Data / Medical devices / United States / Becton Dickinson
Becton Dickinson: FDA-registered device maker in Franklin Lakes, NJ, United States, 102 510(k) clearances
Becton Dickinson is registered with the FDA (registration 2243072) in Franklin Lakes, NJ, United States. It lists 52 device types. The FDA files 102 510(k) clearances under its listings, the newest dated April 15, 2026. 129 recall events name it as the recalling firm (4 Class I). Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 2243072
- Address
- 1 Becton Dr, Franklin Lakes, NJ, United States, 07417
- Owner or operator
- Becton Dickinson and Company (9922032)
- Roles
- Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- July 12, 1991
- Registered through
- 2027
- Brand names listed
- Alcohol Swab, B-D GUARDIAN NESTABLE SHARPS COLLECTORS, BACTO-CAPILLARY TUBES, BD 1mL Luer-Lok Hypodermic Syringe, BD 1mL Luer-Lok Hypodermic Syringe with BD Eclipse Hypodermic Needle, BD 1mL Luer-Lok Hypodermic Syringe with BD Hypodermic Needle, BD 1mL Luer-Lok Insulin Syringe, BD 1ml Insulin Syringe U-100 Luer-Lok Tip and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance. Newest 100 of 102.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 15, 2026 | K260128 | BD Preset and BD A-Line Arterial Blood Collection Syringes | JKA | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| April 10, 2026 | K252506 | BD Vacutainer® Safety-Lok Blood Collection Set; BD Vacutainer® Safety-Lok Blood Collection Set with Pre-Attached Holder | JKA | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| April 10, 2026 | K252378 | BD® MiniDraw Capillary Blood Collection System with BD® MiniDraw SST Capillary Blood Collection Tube | JKA | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| March 13, 2026 | K252040 | BD Vacutainer® Plasma Separator Tubes (PST), BD Vacutainer® Sodium Heparin Blood Collection Tubes | JKA | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| December 2, 2025 | K250884 | 0.9 % Sodium Chloride Injection, USP, BD PosiFlush SP Syringe | NGT | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| September 12, 2025 | K250059 | BD PhaSeal Optima Connecting Set (C83-O); BD PhaSeal Optima Spike Set (C180-O) | ONB | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| July 29, 2025 | K251350 | BD Plastipak Syringe | FMF | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| July 3, 2025 | K243207 | BD Vacutainer® Eclipse Blood Collection Needle | JKA | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| March 21, 2025 | K243649 | BD Vacutainer® Multiple Sample Luer Adapter | JKA | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| November 1, 2024 | K242320 | BD Vacutainer® One Use Holder | JKA | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| February 2, 2024 | K231373 | BD Vacutainer® K2 EDTA Blood Collection Tubes | JKA | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| January 19, 2024 | K231237 | BD Vacutainer® Fluoride Blood Collection Tubes | JKA | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| December 20, 2023 | K230855 | BD Vacutainer® Serum Separator (SST) Blood Collection Tubes | JKA | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| December 1, 2023 | K230391 | BD MiniDraw Capillary Blood Collection System with BD MiniDraw SST Capillary Blood Collection Tube | JKA | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| November 27, 2023 | K230493 | BD MiniDraw Capillary Blood Collection System with BD MiniDraw H&H Capillary Blood Collection Tube | GIM | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| August 25, 2023 | K213670 | BD Vacutainer K2EDTA Blood Collection Tubes, BD Vacutainer K3EDTA Blood Collection Tubes | GIM | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| July 21, 2023 | K231161 | 0.9% Sodium Chloride Injection, USP BD PosiFlush SF Saline Flush Syringe | NGT | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| July 17, 2023 | K213953 | BD Vacutainer® Trace Element K2EDTA Tubes, BD Vacutainer® Trace Element Serum Tubes | JKA | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| March 24, 2023 | K220212 | BD Vacutainer® Push Button Blood Collection Set, BD Vacutainer® Push Button Blood Collection Set with Pre-Attached Holder | JKA | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| March 10, 2023 | K222478 | BD Vacutainer® Luer-Lok Access Device, BD Vacutainer® Blood Transfer Device | JKA | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| December 16, 2022 | K223243 | BD Microtainer® Contact-Activated Lancets; BD Microtainer® Quikheel Lancets | FMK | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| July 16, 2022 | K213955 | 0.9% Sodium Chloride Injection, USP, BD PosiFlush SafeScrub | QTI | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| July 1, 2022 | K211085 | BD Perisafe Tuohy Epidural Needle, BD Perisafe Weiss Epidural Needle | BSP | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| May 19, 2022 | K210983 | BD Epilor Syringe | CAZ | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| February 4, 2022 | K212724 | BD Vacutainer UltraTouch Push Button Blood Collection Set | JKA | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| December 22, 2021 | K210978 | BD Quincke Spinal Needle, BD Whitacre Spinal Needle, BD Spinal Introducer Needle | BSP | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| November 9, 2020 | K193190 | BD PureHub Disinfecting Cap | QBP | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| September 29, 2020 | K193131 | BD Quincke Spinal NRFit Needle, BD Whitacre Spinal NRFit Needle, BD Spinal Introducer NRFit Needle | BSP | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| September 25, 2020 | K202446 | BD Preset Syringe & BD A-Line Syringe | JKA | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| September 4, 2020 | K192538 | BD Syringe NRFit Lok and BD Syringe NRFit Slip | QEH | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| August 12, 2020 | K201099 | BD PhaSeal Optima Closed System Drug Transfer Device | ONB | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| March 14, 2019 | K182589 | BD Plastipak Syringe | FMF | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| December 20, 2018 | K182320 | BD Contoured Base Pen Needle | FMI | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| November 30, 2018 | K181221 | BD PhaSeal Optima Closed System Transfer Device | ONB | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| February 27, 2017 | K163591 | BD PosiFlush Heparin Lock Flush Syringe | NZW | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| February 2, 2017 | K161552 | 0.9% Sodium Chloride Injection, USP BD PosiFlush SP Syringe | NGT | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| December 19, 2016 | K162081 | BD 1ml Luer-lok Hypodermic Syringe, BD 1 mL Luer-Lok Hypodermic Syringe with BD Hypodermic Needle or BD Eclipse Hypodermic Needle, BD 1ml Luer-lok Insulin Syringe | FMF | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| December 9, 2016 | K162516 | BD Pen Needle | FMI | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| May 27, 2016 | K161170 | BD Eclipse Hypodermic Needle | FMI | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| April 4, 2016 | K153481 | 0.9% Sodium Chloride Injection, USP BD PosiFlush SF Syringe | NGT | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| September 2, 2015 | K151766 | BD Single Use, Hypodermic Syringe | FMF | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| July 25, 2014 | K141311 | 0.9% SODIUM CHLORIDE INJECTION, USP BD POSIFLUSH; SP SYRINGE, SF SYRINGE | NGT | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| May 14, 2014 | K140591 | BD PHASEAL CLOSED SYSTEM TRANSFER DEVICE - INJECTOR | ONB | Substantially Equivalent | Becton, Dickinson & CO | accessdata.fda.gov |
| March 20, 2013 | K121655 | BD ALCOHOL SWAB | LKB | Substantially Equivalent | Becton, Dickinson & CO | accessdata.fda.gov |
| February 27, 2013 | K130197 | BD PHASEAL CLOSED SYSTEM TRANSFER DEVICE - P55 | ONB | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| January 9, 2013 | K123213 | BD PHASEAL CLOSED SYSTEM TRANSFER DEVICE | ONB | Substantially Equivalent | Becton, Dickinson & CO | accessdata.fda.gov |
| March 28, 2012 | K112774 | BD RECYKLEEN SHARPS COLLECTORS | MMK | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| September 29, 2011 | K112434 | BD ORAL/ENTERAL SYRINGE WITH BD UNIVIA CONNECTION | KNT | Substantially Equivalent | Bd Medical Surgical | accessdata.fda.gov |
| July 27, 2011 | K110703 | BD AUTOSHIELD DUO PEN NEEDLE | FMI | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| May 13, 2011 | K110771 | BD SINGLE USE, HYPODERMIC SYRINGE | FMF | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| April 28, 2011 | K110105 | BD PEN NEEDLE | FMI | Substantially Equivalent | Becton, Dickinson and Company (BD) | accessdata.fda.gov |
| June 29, 2010 | K101502 | BD VACUTAINER RAPID SERUM TUBE BLOOD COLLECTION TUBE, MODEL 368774 | JKA | Substantially Equivalent | Becton, Dickinson & CO | accessdata.fda.gov |
| February 19, 2010 | K100209 | BD ECLIPSE NEEDLE WITH SMARTSLIP TECHNOLOGY | FMI | Substantially Equivalent | Becton, Dickinson & CO | accessdata.fda.gov |
| January 21, 2010 | K093972 | BD MICROTAINER MAP MICROTUBE FOR AUTOMATED PROCESS, MODEL 363706 | JKA | Substantially Equivalent | Becton, Dickinson & CO | accessdata.fda.gov |
| October 9, 2009 | K091758 | BD SPINAL NEEDLE 27G | BSP | Substantially Equivalent | Becton Dickson & Co. | accessdata.fda.gov |
| August 25, 2009 | K091292 | BD VACUTAINER RAPID SERUM TUBE PLUS BLOOD COLLECTION TUBE, MODEL 368771 | JKA | Substantially Equivalent | Becton, Dickinson and Company (BD) | accessdata.fda.gov |
| July 2, 2009 | K091377 | BD FLU+ SYRINGE | FMF | Substantially Equivalent | Becton, Dickinson & CO | accessdata.fda.gov |
| June 10, 2009 | K090680 | HEPARIN LOCK FLUSH SOLUTION, USP BD POSIFLUSH HEPARIN LOCK FLUSH SYRINGE | NZW | Substantially Equivalent | Becton, Dickinson & CO | accessdata.fda.gov |
| March 16, 2007 | K070440 | BD HYPOINT NEEDLE | FMI | Substantially Equivalent | Becton, Dickinson & CO | accessdata.fda.gov |
| May 14, 2004 | K041071 | BD VACUTAINER TRACE ELEMENT SERUM PLUS TUBE AND BD VACUTAINER TRACE ELEMENT K2EDTA PLUS TUBE, MODELS 368380/368381 | JKA | Substantially Equivalent | Becton, Dickinson & CO | accessdata.fda.gov |
| March 26, 2003 | K024240 | BD VACUTAINER PLUS PLASTIC URINE C&S PRESERVAYIVE TUBES AND KITS | JSM | Substantially Equivalent | Bd | accessdata.fda.gov |
| July 19, 2002 | K021475 | BD SINGLE LUMEN NEEDLE, SYRINGE AND BLOOD COLLECTION SET | FMI | Substantially Equivalent | Bd | accessdata.fda.gov |
| February 1, 2002 | K013971 | BD VACUTAINER SAFETY COAGULATION TUBE | JKA | Substantially Equivalent | Becton, Dickinson & CO | accessdata.fda.gov |
| January 23, 2002 | K011967 | BD PRE-FILLED HEPARIN LOCK FLUSH IN 0.9% SODIUM CHLORIDE INJECTION, USP SYRINGE | FOZ | Substantially Equivalent | Bd | accessdata.fda.gov |
| July 17, 2001 | K011982 | 0.9% SODIUM CHLORIDE INJECTION, USP BD PRE-FILLED FLUSH SYRINGE | FOZ | Substantially Equivalent | Bd | accessdata.fda.gov |
| June 13, 2001 | K011103 | BD SPRING BASED SYRINGE | MEG | Substantially Equivalent | Bd | accessdata.fda.gov |
| March 1, 2001 | K010188 | BD ECLIPSE HYPODERMIC NEEDLE | FMI | Substantially Equivalent | Bd Medical Systems | accessdata.fda.gov |
| November 2, 2000 | K002456 | MICROTAINER BRAND SODIUM FLUORIDE/EDTA TUBE WITH MICROGARD CLOSURE, MODEL 365992 | JKA | Substantially Equivalent | Becton Dickinson Vacutainer Systems | accessdata.fda.gov |
| October 1, 1999 | K992734 | BECTON DICKINSON SYRINGE | MEG | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic | accessdata.fda.gov |
| July 28, 1999 | K991702 | MICROTAINER BRAND CHEMISTRY TUBES WITH MICROGARD CLOSURE, MODEL 365965, 365985, 365963, 365967, 36578 | JKA | Substantially Equivalent | Becton Dickinson Vacutainer Systems | accessdata.fda.gov |
| May 19, 1999 | K991120 | VACUTAINER BRAND CTAD TUBE (MULTIPLE) | JKA | Substantially Equivalent | Becton Dickinson Vacutainer Systems | accessdata.fda.gov |
| June 25, 1998 | K980580 | BECTON DICKINSON SYRINGES | FMF | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic | accessdata.fda.gov |
| June 17, 1998 | K981013 | VACUTAINER PLUS TUBE WITH EDTA ANTICOAGULANT ANDD VACUTAINER PLUS SERUM TUBE | JKA | Substantially Equivalent for Some Indications | Becton Dickinson Vacutainer Systems | accessdata.fda.gov |
| June 11, 1998 | K980987 | BECTON DICKINSON SYRINGE | FMF | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic | accessdata.fda.gov |
| February 24, 1998 | K972075 | VACUTAINER BRAND PPT PLASMA PREPARATION TUBE | PJE | Substantially Equivalent | Becton Dickinson Vacutainer Systems | accessdata.fda.gov |
| October 30, 1997 | K972878 | ULTRASAFE INJECTION SYSTEM NEEDLE GUARD, MODELS B50,B100L,B150,B225, AND B300 | FMF | Substantially Equivalent | Safety Syringes, Inc. | accessdata.fda.gov |
| March 29, 1996 | K960250 | VACUTAINER BRAND PLUS SERUM & SST TUBES | JKA | Substantially Equivalent | Becton Dickinson Vacutainer Systems | accessdata.fda.gov |
| November 30, 1995 | K953790 | BD PERISAFE EPIDURAL ANESTHESIA TRAY | CAZ | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic | accessdata.fda.gov |
| November 28, 1995 | K954592 | VACUTAINER BRAND PST PLASMA SEPARATION TUBE | JKA | Substantially Equivalent | Becton Dickinson Vacutainer Systems | accessdata.fda.gov |
| October 7, 1995 | K951254 | SAFETYGLIDE NEEDLE | FMI | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic | accessdata.fda.gov |
| January 11, 1995 | K944757 | PISTON SYRINGES | FMI | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic | accessdata.fda.gov |
| November 28, 1994 | K943139 | B-D GUARDIAN ONE PIECE SHARPS COLLECTORS | FMI | Substantially Equivalent | Med-Safe Systems, Inc. | accessdata.fda.gov |
| November 28, 1994 | K943138 | VACUTAINER BRAND NEEDLE DISPOSAL CONTAINER | MMK | Substantially Equivalent | Med-Safe Systems, Inc. | accessdata.fda.gov |
| November 10, 1994 | K944566 | VACUTAINER BRAND PLUS SODIUM HEPARIN TUBE | JKA | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic | accessdata.fda.gov |
| November 7, 1994 | K943141 | B-D GUARDIAN POINT OF USE HORIZONTAL AND SIDE ENTRY SHARPS COLLECTORS | FMI | Substantially Equivalent | Med-Safe Systems, Inc. | accessdata.fda.gov |
| November 7, 1994 | K943140 | B-D GURADIAN CHEMOTHERAPY SHARPS COLLECTORS | FMI | Substantially Equivalent | Med-Safe Systems, Inc. | accessdata.fda.gov |
| November 7, 1994 | K943134 | B-D GUARDIAN NESTABLE SHARPS COLLECTORS | FMI | Substantially Equivalent | Med-Safe Systems, Inc. | accessdata.fda.gov |
| October 14, 1994 | K943575 | B-D GUARDIAN NESTABLE SHARPS COLLECTORS | FMI | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic | accessdata.fda.gov |
| August 2, 1994 | K940905 | MICROTAINER BRAND TUBE WITH EDTA(K2) | JKA | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic | accessdata.fda.gov |
| May 26, 1994 | K941562 | 1ML LUER-LOK SYRINGE | FMF | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic | accessdata.fda.gov |
| September 28, 1993 | K931368 | MICROTAINER BRAND TUBE WITH EDTA | JKA | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic | accessdata.fda.gov |
| August 27, 1993 | K932249 | DURASAFE B-D COMBINED SPINAL EPIDURAL ANESTHESIA | CAZ | Unknown | Bd Becton Dickinson Vacutainer Systems Preanalytic | accessdata.fda.gov |
| January 14, 1993 | K925902 | B-D LOSS OF RESISTANCE SYRINGE | CAZ | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic | accessdata.fda.gov |
| December 17, 1992 | K924072 | BECTON DICKINSON SAFETY-LOK SYRINGE | FMF | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic | accessdata.fda.gov |
| December 15, 1992 | K911731 | LEUCOPREP(R) BRAND CELL SEPARAT TUBE W/SODIUM CITR | JCF | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic | accessdata.fda.gov |
| August 9, 1990 | K901449 | VACUTAINER PLUS WITH HEMOGARD CLOSURE | JKA | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic | accessdata.fda.gov |
| May 26, 1989 | K891407 | LEUCOPREP CELL SEPARATION TUBE | JCF | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic | accessdata.fda.gov |
| September 14, 1988 | K881697 | BREAST LESION LOCALIZATION NEEDLE | IZH | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic | accessdata.fda.gov |
| June 1, 1988 | K880988 | PUDENDAL/LOCAL ANESTESIA BLOCK TRAY | KNE | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic | accessdata.fda.gov |
| September 4, 1987 | K872233 | INJECT-EASE | KZH | Substantially Equivalent | Palco Laboratories, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI. Newest 100 of 129.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| April 27, 2026 | 98842 | Class I | Ongoing | BDSpinal Tray with BDQuincke Needle 22 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (8.25%), 2 mL (marcaine). Catalog Number: 405609. | This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identified during an FDA manufacturing facility inspection, citing specific quality deficiencies related to acceptance testing. | accessdata.fda.gov |
| January 27, 2026 | 98314 | Class II | Ongoing | 10mL Non-Sterile BD Luer-Lok Tip Syringe Only. Catalog Number: 301029. 850 bulk non-sterile units per case. | During the bulk packaging process, some Luer Slip syringes were incorrectly included in a batch designated for Luer Lok syringes. | accessdata.fda.gov |
| October 14, 2025 | 97737 | Class II | Ongoing | BD Luer Tip Caps; Catalog Number(s) or Model Number(s): 308341 | BD has confirmed through internal testing that certain device trays failed routine biocompatibility testing. | accessdata.fda.gov |
| November 16, 2023 | 93562 | Class II | Ongoing | PosiFlush Prefilled Saline Syringe with General Pump Compatibility (10mL Syringe with 10mL Saline Fill), Catalog Number 306547 | An incorrect stopper was used in nine lots of 10mL BD PosiFlush Normal Saline Flush Syringes with General Pump Compatibility. The use of BD PosiFlush Prefilled Flush Syringes with this stopper causes an increase in injection force, which has the potential to trigger alarms if used with a syringe pump. | accessdata.fda.gov |
| October 11, 2023 | 93266 | Class II | Ongoing | BD Alaris Pump infusion sets (Product Name, Catalog #) BD AlarisTM Pump Infusion Set Vented syringe adapter Smallbore Tubing, Catalog # 10010483; BD AlarisTM Pump Infusion Set 1.2 Micron Filter Low Sorbing Tubing (PE Lin | Affected infusion sets labeled as free of DEHP actually do contain di(2-ethylhexyl) phthalate (DEHP). | accessdata.fda.gov |
| February 1, 2023 | 91495 | Class II | Ongoing | BD Ultra-Fine Insulin Syringe 0.5mL, 6mm, 31G - Insulin Syringes are designed for administering insulin in the treatment of diabetes mellitus. Catalog Number: 326679 | Nonsterile syringe potentially exposing the patient to pathogenic microorganisms and a risk of local infection. | accessdata.fda.gov |
| September 15, 2022 | 90824 | Class II | Ongoing | BD Vacutainer Tube Sodium Fluoride: 100 mg, Potassium Oxalate: 20 mg, Catalog Number 367001. For collecting, transporting, separating, and processing blood for blood alcohol determination. | The affected product contains isobutylene which has recently demonstrated potential interference in determination of methanol by gas chromatography methods. The interference may lead to false positive results in methanol testing. | accessdata.fda.gov |
| July 18, 2022 | 90567 | Class II | Ongoing | BD PhaSealTM Y-Site Connector (C80)- airtight and leak-proof Closed System Drug Transfer Device (CSTD) that mechanically prohibits the transfer of environmental contaminants into the system and the escape of drug or vapo | Incorrect expiration date listed on the product labels. The expiration date listed on the product label is beyond the expiration date of the product. | accessdata.fda.gov |
| May 9, 2022 | 90304 | Class II | Ongoing | BD Connecta Stopcock with OFF Directed Tap Without Extension Tube (500 eaches/carton) Catalog No. 394910 (US) | May have the potential for leakage at the housing component of the stopcock, may result in delay or interruption in treatment, exposure to infusate and biohazardous material, under dosing/under infusion, contamination and/or air ingress. | accessdata.fda.gov |
| January 6, 2022 | 89486 | Class III | Ongoing | BD Vacutainer Luer Lok Access Device - intended as a sterile, single use device designed to provide a connection to a catheter port equipped with a threaded female luer during blood or urine sample collection using evacu | May shed contaminant particles into the urine specimen that may be misidentified as Red Blood Cells when used in conjunction with the Sysmex UF-1000i or UX-2000 Analyzers and lead to false elevations in RBC counts | accessdata.fda.gov |
| September 27, 2021 | 88805 | Class II | Terminated | BD Syringe Tip Cap Bulk Sterile Convenience Pak-1000 units/shelf carton. Used to seal syringes and maintain container closure integrity throughout the shelf life of the BD WWD syringe. Catalog Number: 305822 | Holes in product packaging impacts package integrity and may compromise sterility. | accessdata.fda.gov |
| December 23, 2020 | 87158 | Class II | Terminated | BD Hypodermic Syringe 10 ml, eccentric tip. Catalog (Ref No.) 305482 | The product packaging for the 10 ml eccentric tip syringe may exhibit open seals. An open seal impacts package integrity and potentially compromises sterility of the syringe. | accessdata.fda.gov |
| December 9, 2020 | 86994 | Class II | Terminated | BD Stimex Insulated Needle 22G x 2.13in ( 50 units/cs.) Indicated for administration of medications to affect anesthesia or analgesia to a specific anatomical location (region). Catalog No. 404204 | BD was advised by the European Notified Body, NSAI, that the instructions for use (IFU) needs to be updated to include the general contraindications | accessdata.fda.gov |
| November 18, 2020 | 86857 | Class II | Terminated | BD PrecisionGlide Needle 30G x 1/2 (0.3 mm X 13mm) REF 305106 - Product Usage: used for general purpose injection and aspiration of fluids from vials, ampoules and parts of the body below the surface of the skin. | BD has confirmed the presence of blood on the cannulas of the BD PrecisionGlide needles 30G X 1/2" Lot No. 9128897. The possibility of infection may be present if the blood is not noticed prior to use by the clinician. | accessdata.fda.gov |
| October 23, 2020 | 86679 | Class II | Terminated | BD Ultra-Fine Pen Needles 32G x 4mm (5/32' )-intended for parenteral administration of a drug from a cartridge contained in a drug pen injector Catalog Number: 320122 | Product shelf cartons incorrectly labeled as products intended for the Latin American market. Although the product description on the label 32G x 4mm pen needles is correct, information pertinent to users in the US regarding compatibility with specific pen needles is missing. | accessdata.fda.gov |
| September 14, 2020 | 86477 | Class II | Terminated | Bard 3F SL PowerMidline Basic Kit CE-indicated for short term access to the peripheral venous system for selected intravenous therapies, blood sampling, and power injection of contrast media Ref: P6153118 | Kits do not contain the stylet/T-lock assembly indicated as a component on the label, may lead to a procedural delay and possibly discard of the kit. | accessdata.fda.gov |
| September 14, 2020 | 86434 | Class II | Terminated | BD Nexiva Closed IV Catheter System Dual Port (20 GA 1.75 IN) Catalog (Ref) No. 383538 BD Nexiva closed IV catheter systems are intended to be inserted into a patient s vascular system for short term use to sample blood, | Dull/blunt needles within the IV Catheter System may lead to missed insertion attempts and delay in diagnosis or treatment until a new needle is inserted | accessdata.fda.gov |
| July 28, 2020 | 86120 | Class II | Terminated | BD SafetyGlideTM 3ml 25G x 1 3mL SafetyGlide syringes, 50 units in pack | Printed scale markings on the 3mL SafetyGlide syringes, with catalog # 305924, Lot# 8289599, are printed incorrectly. The scale is skewed to different degrees, resulting in missing and/or partially printed scale numbers and scale lines. | accessdata.fda.gov |
| June 19, 2020 | 85853 | Class II | Terminated | PowerLoc MAX Power Injectable Infusion Set AllPoints Port Access System; Catalog Numbers AN132075 (UDI 00801741118968), AN142010 (UDI 00801741119231), AN142010G (UDI 00801741119323), AN142075 (UDI 00801741119224) | Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. Devices that have developed breaks or cracks can cause leakage resulting in exposure to chemicals such a chemotherapeutics or biohazard material (e.g., blood). A crack or break could result in potential blood loss, catheter occlusion, air embolism, under or interru | accessdata.fda.gov |
| April 16, 2020 | 85432 | Class II | Terminated | BD Posiflush SF Saline Flush Syringe (US Distributed Catalog 306553), UDI 50382903065535 | This product has been confirmed to exhibit holes in the packaging, which impacts package integrity and potentially compromises a sterile field. | accessdata.fda.gov |
| March 26, 2020 | 85380 | Class II | Terminated | CareFusion Safe-T-Centesis Catheter Drainage Tray, Sterile, For Single Use Only, Rx only, Catalog Number PIG1280T, UDI Number 01)10885403108402(17) 210930(10)0001304986 | The 8 Fr catheter was manufactured with the 6.9 Fr needle instead of the 8 Fr needle. | accessdata.fda.gov |
| March 17, 2020 | 85287 | Class II | Terminated | PowerGlide ST Midline Catheter Maximal Barrier Kit-18 gauge,10 cm length Catalog Number: ST018101D | Iincorrectly packaged without the required lidocaine as labeled | accessdata.fda.gov |
| February 26, 2020 | 85334 | Class II | Terminated | BARD MYPICC KIT 5F Dual-Lumen, Catalog Number CK000025 | The kits contain surgical gowns which were subject to a recall by the supplier. | accessdata.fda.gov |
| November 4, 2019 | 84262 | Class II | Terminated | Site~Rite 8 Ultrasound Systems-intended for diagnostic ultrasound imaging of the human body. Site~Rite 8 Ultrasound System, Catalog No.9770500 Refurbished, Site~Rite 8 System, Catalog No.9770500R Site~Rite 8 Ultrasound S | The indicator may show available charge when the battery is close to depletion. As a result, the Site~Rite 8 has the potential to abruptly shut down, without advance warning to the user, when running on battery power only | accessdata.fda.gov |
| October 14, 2019 | 84113 | Class II | Terminated | BD Posiflush Pre-Filled Normal Saline Syringes Catalog Number: 306547 | Limited number of syringes labeled Posiflush Experimental Product and Not for Human Use being mixed with standard BD Posiflush Pre-Filled Normal Saline Syringes. | accessdata.fda.gov |
| September 16, 2019 | 83886 | Class II | Terminated | 13 Fr. Trialysis Catheter with Alphacurve. Catalog No. 5653150. UDI: 00801741066023 Power-Trialysis Short-Term Alphacurve Dialysis Catheter with a third internal umen for IV therapy, power injection of contrast media, an | A portion of the lot was incorrectly packaged with a 12.5cm catheter instead of a 15cm catheter. | accessdata.fda.gov |
| August 1, 2019 | 83537 | Class II | Terminated | 8 G x 10 CM Jamshidi Crown Bone Marrow biopsy/Aspiration Needle with MAC Catalog Number: TMJ4008 | Product Pouches may not be sealed properly and compromise the sterility of the device | accessdata.fda.gov |
| July 31, 2019 | 83507 | Class II | Terminated | BD Vacutainer Push Button Blood Collection Set with Pre-Attached Holder Catalog number 368356 - Product Usage: This product is designed to provide customers an increased level of safety during IV blood collection, conven | Separation of front and rear barrels upon activation of the safety feature that retracts the needle | accessdata.fda.gov |
| June 12, 2019 | 82963 | Class II | Terminated | BD Vacutainer Lithium HeparinN (LH) 37 USP Units Blood Collection Tubes, Catalog Number 366664 | False elevation of carboxyhemoglobin (COHb) results have been reported when using venous blood gas samples collected with tubes analyzed with the IL GEM 4000 instrument. | accessdata.fda.gov |
| June 3, 2019 | 83052 | Class II | Terminated | BD Microtainer Tube w/ BD Microgard Closure, K2EDTA additive, Model Numbers 365974 and 365975 Product Usage: The Microtainer Brand Tube with EDTA(K2) Reorder No. 365974, is used to collect, anticoagulate, transport and s | The products have been confirmed to have reduced or no additive within the tube reservoir. The tubes may develop visible clots within the tube samples or micro clots that are not easily detected during visual inspection of the tubes. A clotted sample may lead to recollection of samples or, retesting of patients, resulting in delayed reporting of test results | accessdata.fda.gov |
| May 30, 2019 | 83020 | Class II | Terminated | BD Vacutainer Fluoride Tubes for Blood Alcohol determinations Part Number: 367001 Product Usage: Blood Alcohol determinations | Lot has been confirmed to have no additive within the tube. Sample processed without the preservative (additive) in the tube, testing has yielded reliable results if the samples were stored at room temperature for no longer than two days. If the sample was stored for more than 2 days, the result for blood alcohol determination might not be accurate (either f | accessdata.fda.gov |
| May 13, 2019 | 82851 | Class II | Terminated | BD Microtainer Z (No Additive Tubes) Part/Catalog No.365963 | Damaged reservoir may lead to a decreased fill volume causing samples to be insufficient for testing and improper blood-to-additive ratio, potentially producing erroneous results. | accessdata.fda.gov |
| May 6, 2019 | 82752 | Class I | Terminated | Alaris Pump Infusion Set, Model Codes 10010453, 10010454, 10012144, 10015294, 10015414, 10933805, 11171447, 11404930, 11522558, 11607704, 10013361T, 2110-0500, 2126-0500, 2200-0500, 2411-0500, 2419-0007, 2420-0007, 2420- | An incomplete occlusion can be caused by a variation in the wall thickness of the pumping segment of the affected infusion sets used with the. The issue has the potential to lead to unintended delivery of medication when the pump module is not in running status or can result in faster than expected drug delivery flow when the pump is infusing. | accessdata.fda.gov |
| May 2, 2019 | 82970 | Class II | Terminated | CareFusion MaxPlus Clear Needleless Connector. Intended for Positive Displacement Connector for needleless access to the IV line and/or IV catheter during IV therapy Cat. No. MP1000-C | After disconnection of a luer, the valve of the connector remains recessed; not fully closing, either temporarily or permanently. The risks of blood loss and air embolism exist if the valve remains permanently open and goes undetected, especially in the neonate population. | accessdata.fda.gov |
| April 10, 2019 | 82453 | Class II | Terminated | MaxZero Extension Sets with Needle-less Connector, Product codes MZ1000 MZ1000-07 MZ5301 MZ5302 MZ5303 MZ5304 MZ5305 MZ5306 MZ5307 MZ5309 MZ5310 MZ5312 MZ5313 MZ5316 MZ8001 MZ8002 MZ8003 MZ9266 MZ9267 MZ9272 MZ9273 MZ927 | BD has decided to initiate a voluntary recall due to a confirmed complaint trend for droplets of fluid separating from the sealed surface of the MaxZero connector, following disconnection. | accessdata.fda.gov |
| March 7, 2019 | 82351 | Class II | Terminated | BD Vacutainer Eclipse Blood Collection Needles 22Gx1.25, cat. no. 368608 | BD PAS received customer complaints indicating the absence of the bevel on the non-patient needle end of the product, causing blood leakage. | accessdata.fda.gov |
| March 7, 2019 | 82317 | Class II | Terminated | BD Blood Collection Assembly with Male Luer Lock, Catalog Number MBC6010 | The luer could break and cause the device to leak or break off and get stuck in the fistula needle port rendering the port inaccessible for dialysis. As a result, the patient would need to be re-cannulated with a new fistula needle to obtain their dialysis treatment. | accessdata.fda.gov |
| March 5, 2019 | 82350 | Class II | Terminated | Gravity IV Set with 3-port Closed Stopcock Manifold Model CS42522E-07 | The firm has initiated a recall due to a confirmed complaint trend for kinked tubing on the specified lots of the product. | accessdata.fda.gov |
| March 1, 2019 | 82330 | Class II | Terminated | BD Nexiva Dual Port 20GA 1.00IN -Closed IV Catheter System intended for use in the peripheral vascular system Catalog Number: 383536 | Leak from the septum assembly or the canister may burst under high pressure which could result in blood exposure to a health care worker. | accessdata.fda.gov |
| February 28, 2019 | 82273 | Class I | Terminated | SmartSite Syringe Administration Set-Product Package Size 50, Catalog Number: 10798696 | Leaking of the Smartsite Syringe Administration Set. May result in delay or interruption of infusion, under-infusion, contamination of the fluid path and HCP exposure to infusates. | accessdata.fda.gov |
| February 1, 2019 | 82138 | Class II | Terminated | 3mL Luer-Lok Syringe, Catalog Number 309657, UDI 30382903096573 | The syringes have scale markings that were printed incorrectly. The scale is skewed to varying degrees, resulting in missing and/or partially printed scale numbers and scale lines. | accessdata.fda.gov |
| September 26, 2018 | 81181 | Class II | Terminated | PCEA ASV Yellow Microbore, Catalog Numbers 30893, 30893-07 Product Usage: PCEA Administration Set. Microbore tubing with Yellow Identification Stripe. Anti-siphon valve. Set cannot be used for gravity infusion 1. Connect | The products have the potential to leak between the connection of the male luer lock and the yellow striped tubing. | accessdata.fda.gov |
| August 30, 2018 | 81148 | Class II | Terminated | BD Vacutainer Urine Collection Cups, Cat. No. 364941 | BD Vacutainer Urine Collection Cups may contribute to a slight elevation of Red Blood Cell (RBC) counts when used with the Sysmex UF Series Analyzers. BD recommends following Good Clinical Practice (GCP) by using microscopy to confirm an elevated RBC Count in a Urine sample as per CLSI GP16-3A. 29(4) and CAP Checklist on Urinalysis. Product will continue to | accessdata.fda.gov |
| August 23, 2018 | 81040 | Class II | Terminated | BD NEXIVA Closed IV Catheter System Dual Port 18GA 1.25 IN (BD Nexiva Catheter), Catalog Number 383539 Product Usage: BD Nexiva Closed IV Catheter System Dual Port (hereafter referred to as BD Nexiva device or catheter) | One lot of the specified needles is not performing as intended due to a failure in the needle tip shield/safety mechanism, which may lead to an increased risk of a contaminated needlestick injury. | accessdata.fda.gov |
| April 11, 2018 | 79901 | Class II | Terminated | The BD Vacutainer Plus Plastic Citrate Blood Collection Tube is an evacuated blood collection tube that provides a means of collecting, transporting, and processing blood in a closed tube. The buffered sodium citrate add | Approximately 3.4% of BD Vacutainer Plus Plastic Citrate Blood Collection Tubes (2.7mL) (light blue top tube) will exhibit over fill draw volumes from ~11-14%. | accessdata.fda.gov |
| March 22, 2018 | 79223 | Class I | Terminated | BD Vacutainer EDTA Lavender Top Tubes: Catalog Numbers: 1. 366401 (UDI: 50382903664011); 2. 366450 (UDI: 50382903664509); 3. 366643 (UDI: 50382903666435); 4. 367835 (UDI: 50382903678353); 5. 367841 (UDI: 50382903678414); | BD Vacutainer EDTA Lavender, Tan, and Pink Top Tubes and BD Vacutainer Lithium Heparin Green Top Tubes can cause an underestimation of lead in blood samples when used with Magellan Diagnostics LeadCare assays, employing the Anodic Stripping Voltammetry (ASV) methodology, or any other assay employing ASV methodology. | accessdata.fda.gov |
| March 20, 2018 | 79687 | Class II | Terminated | BD Vacutainer Push Button Blood Collection Set 0.6 x 19 mm x 305 mm 23G x x 12 (Catalog no 367342) | Products do not meet the labeled sterility claim of a Sterility Assurance Level (SAL) 10-6. | accessdata.fda.gov |
| February 13, 2018 | 79709 | Class II | Terminated | BD VACUTAINER PLUS SST Tube with HEMOGARD closure 13x75mm 3.5ml PLBL Gold, Catalog No. 367983 | Tubes may exhibit stopper creepout/pullout, where the stopper dissociates from the tube | accessdata.fda.gov |
| September 18, 2017 | 78909 | Class II | Terminated | BD Vacutainer Barricor" Lithium Heparin Plasma Blood Collection Tubes for Invitro Diagnostic Use, Catalog Numbers: 365043, 365044, 365045 & 365047 Used to collect, separate, process, transport and store venous blood samp | Increased amount of residual blood present on the top of stopper well after venipuncture | accessdata.fda.gov |
| August 29, 2017 | 79041 | Class II | Terminated | BD Vacutainer K2 EDTA (K2E) 3.6mg Blood Collection Tube (13 x 75 mm x 2.0 mL). Catalog Number: 367841. Used for whole blood hematology determinations, immunohematology testing and blood donor screening. | A limited portion of the lot was manufactured with less than the required amount of K2EDTA additive, an anticoagulant, which may cause erroneous results that could lead to specimen recollection and potential delay of treatment or misdiagnosis/mismanagement of treatment and serious complications, such as failure to detect thrombocytosis or postponing surgery. | accessdata.fda.gov |
| June 13, 2017 | 77650 | Class II | Terminated | BD Needle 22GA 1-1/2in SafetyGlide(TM) Non Sterile, Bulk, REF 301701 The BD SafetyGlide(TM) needle is intended to be used for general purpose injection, aspiration of fluids from parts of the body below the surface of th | Presence of loose polypropylene foreign matter above release specification. | accessdata.fda.gov |
| May 31, 2017 | 77639 | Class II | Terminated | BD Precision Glide Needle 18G x 1 RB, Catalog 305195 Product Usage: These needles are intended for general purpose fluid injection/aspiration, infusion, venipuncture to obtain blood collection and insulin injection. | Hub damage resulting in breakage and/or leakage during use. | accessdata.fda.gov |
| May 25, 2017 | 77415 | Class II | Terminated | BD Insulin Syringes with the BD Ultra-Fine(TM) needle mL 12.7mm 30G, Catalog/REF 328466 BD Insulin Syringes are intended for the subcutaneous injection of insulin | Product mislabel. Lot 6291768 of the BD Insulin Syringes with the BD Ultra-Fine needle mL 12.7mm 30G, Cat (Ref) 328466, was found to have some polybags in the lot incorrectly labeled as BD Ultra-Fine needle mL 8mm 31G, Cat (Ref) 328468. The shelf carton and case carton are correctly labeled as BD Ultra-Fine needle mL 12.7mm 30G. | accessdata.fda.gov |
| March 16, 2017 | 76826 | Class II | Terminated | BD Vacutainer Buffered Sodium Citrate: (9NC) Blood Collection Tubes, 4.5 mL, 13 x 75 mm, Mfd: Becton Dickinson and Company Product Usage: The BD Vacutainer Safety Coagulation tube is an evacuated blood collection Tube th | BD is initiating this product correction of multiple lots of BD Vacutainer Buffered Sodium Citrate: (9NC) Blood Collection Tube (13x75 mm x 4.5 mL). A limited number of tubes in these lots may exhibit stopper pullout from the tube as the user removes the needle from the stopper following specimen collection. | accessdata.fda.gov |
| January 27, 2017 | 78329 | Class II | Terminated | BD Vacutainer Sodium Polyanetholesulfonate 5.95 mg Sodium Chloride 14.4 mg Blood Collection Tubes for Microbiological Studies (8.3 mL * 16x100mm) Catalog No. 364960 | After a receiving a customer complaint for incorrect labeling, BD has confirmed that a portion of SPS tubes associated with catalog 364960, lot 6090812 were incorrectly labeled at the case and shelf pack level. | accessdata.fda.gov |
| January 16, 2017 | 76295 | Class II | Terminated | BD Vacutainer Buffered Sodium Citrate: (9NC) Blood Collection Tube (4.5 ml x 13 x 75 mm) Catalog Number: 369714 Product Usage: The BD Vacutainer Safety Coagulation tube is an evacuated blood collection tube that provides | A portion of this lot of blood collection tubes was manufactured with approximately twice the expected amount of buffered sodium citrate additive, an anticoagulant. | accessdata.fda.gov |
| December 23, 2016 | 76294 | Class II | Terminated | BD FlowSmart Set MiniMed Pro-set Rx Only Distributed by Medtronic MiniMed Inc. 8006464633 8185765555 Legal Manufacturer Becton, Dickinson and Company USA BD Medical-Diabetes Care Becton Dickinson France SAS | Patients are reporting high blood glucose (HBG) levels while using the MiniMed Pro-set and also noticed the catheter of the infusion set was bent/kinked. | accessdata.fda.gov |
| December 20, 2016 | 76129 | Class II | Terminated | Eclipse Hypodermic Needle | BD is initiating a Product Advisory for the Eclipse Hypodermic Needle because of safety complaints covering disengagement and needlestick injuries. | accessdata.fda.gov |
| November 7, 2016 | 75802 | Class II | Terminated | BD Spinal Anesthesia Tray The BD Spinal Anesthesia Tray is intended for use by professional anesthesiologists to perform the spinal anesthesia procedure | BD is conducting a voluntary product recall of the BD Spinal Anesthesia Tray, Cat (Ref) 405671, lot B01K089D since a very low number of trays are incorrectly labeled as BD Single Shot Epidural Tray, Cat (Ref) 406069. | accessdata.fda.gov |
| September 16, 2016 | 77513 | Class II | Terminated | BD 5ml Syringe Luer-Lok" Tip with Blunt Fill Needle 18G x 1 1/2 (1.2mm x 40mm) Catalog #305062 | BD identified that several lots did not receive the specified dose of irradiation necessary to meet the Sterility Assurance Level (SAL) required. | accessdata.fda.gov |
| August 8, 2016 | 75252 | Class II | Ongoing | BD 23 G x.75 in. BD Vacutainer Push Button Blood Collection Set with 12 in. Tubing Catalog # 367342 Intended for venipuncture to obtain blood specimens from patients. | BD has received multiple reports of units associated with the 23 G x.75 in. BD Vacutainer Push Button Blood Collection Set with 12 in. Tubing whose lots are exhibiting separation of front and rear barrels upon activation of the safety feature, which retracts the needle. | accessdata.fda.gov |
| August 8, 2016 | 74909 | Class II | Terminated | BD Vacutainer Push Button Blood Collection Set, Sterile, Rx only, 0.6 x 19 mm x 305 mm, 23G x 3/4" x 12", REF 367342. | Becton Dickinson is recalling various lot numbers of BD Vacutainer Push Button Blood Collection Set because of reports that specific lots exhibit separation of fron and rear barrels upon activation of the safety feature, which retracts the needle. | accessdata.fda.gov |
| August 2, 2016 | 75150 | Class II | Terminated | catalog # 405612 BD Spinal Anesthesia Tray 22G x 3.5 in. BD" Quincke Spinal Needle Lidocaine HCL (5%) with Dextrose (7.5%), 2 mL catalog # 405622 BD Spinal Anesthesia Tray 25G x 3.5 in. BD" Quincke Spinal Needle Bupivaca | A recall was initiated by Hospira, Inc. for several lots of 5% Lidocaine HCI and 7.5% Dextrose Injection, USP, 2mL Ampul, NDC # 0409-4712-01. Some BD" Spinal Trays contain the 5% Lidocaine Hydrochloride and 7.5% Dextrose Injection, USP, 2mL Ampul (NDC Number 0409-4712-01) being recalled by Hospira. As a result, BD is initiating a recall for the affected BD S | accessdata.fda.gov |
| March 25, 2016 | 73828 | Class II | Terminated | Henry Schein Single Use Syringe Luer-Lock, 10 mL, Intended for use by health care professionals for general purpose fluid aspiration/injection | BD 10 mL Syringe Luer-Lok Tip with BD PrecisionGlide Needle 21G x 1 (0.8 mm x 25 mm) and Henry Schein 10 mL Single Use Syringe Luer-Lock are being recalled due to possible adulteration and non-conforming manufacturing practices. | accessdata.fda.gov |
| March 18, 2016 | 73691 | Class II | Terminated | 1) 24 G x 0.75 in. BD Angiocath" Autoguard" shielded IV catheter (0.7 mm x 19 mm) made of FEP polymer catalog number 381700 2) 24 G x 0.56 in. BD Angiocath-N" Autoguard" shielded IV catheter (0.7 mm x 14 mm) made of FEP | The device may have a defect in the catheter. In some instances this defect could result in catheter separation or breakage. | accessdata.fda.gov |
| December 9, 2015 | 73008 | Class II | Terminated | BD Intelliport Medication Management System Sensor The system is indicated for use by healthcare professionals in a hospital or medical center setting with patients who are receiving manually administered bolus intraveno | The sterility of the product cannot be assured. This may result in increased risk of infection. | accessdata.fda.gov |
| December 3, 2015 | 72868 | Class II | Terminated | BD Vacutainer PLUS K2EDTA Tubes (Plastic). 13 x 75 mm x 2.0 mL (Pink) BD Hemogard Additive: K2EDTA (spray dried), 3.6mg Sterile IVD BD, Made in USA The Vacutainer Brand PLUS (Plastic) Tube with EDTA Vacutainer Brand Seru | Some of the Blood Collection Tubes in these lots were manufactured with insufficient EDTA additive. An insufficient EDTA additive may lead to erroneous platelet results, specimen recollection, or a delay of treatment. | accessdata.fda.gov |
| November 17, 2015 | 72700 | Class II | Terminated | BD Vacutainer K2 EDTA (K2E) 5.4mg Plus Blood Collection Tubes. Product Usage: BD Vacutainer tubes are used to collect, transport and process blood in a closed system. These tubes are used for testing serum, plasma or who | Some tubes were manufactured with the stopper not fully inserted into the tube. This may result in the stopper popping-off in a small number of instances which could lead to blood exposure and in some cases to blood splatter or spraying. | accessdata.fda.gov |
| June 23, 2015 | 71633 | Class III | Terminated | BD Vacutainer SST Plus Blood Collection Tubes, 5.0 mL, 13 x 100 mm, Sterile. Provides a means of collecting, transporting, separating, and processing blood in a closed tube. | Some of the tubes were manufactured with stoppers that did not meet current manufacturing specifications. Stoppers were manufactured with a reduced cycle cure time. | accessdata.fda.gov |
| February 19, 2015 | 70593 | Class II | Terminated | BD Q-Syte Luer Access Split Septum, 0.16 ml, Sterile, Rx only, Catalog REF #385100, Manufacturer: Becton Dickinson Infusion Therapy Systems Inc. An accessory to an intravascular administration set that permits injection, | Becton Dickinson received an elevated number of complaints for blood or infusate/medication leakage due to tearing of the silicone septum. | accessdata.fda.gov |
| December 19, 2014 | 70079 | Class II | Terminated | BD 10 mL Syringe BD Luer-Lok Tip with Blunt Plastic Cannula, Not for Skin Injection; Catalog #303348, BD 10 mL Syringe Luer-Lok Tip with Blunt Fill Needle 18G x 1 1/2 (1.2mm x 40 mm), not for skin injection; Catalog #305 | The stopper of the 10mL BD Luer-Lok syringe is not properly seated in the syringe. | accessdata.fda.gov |
| October 9, 2014 | 69604 | Class II | Terminated | BD Insyte Autoguard Catheter An active safety engineered peripheral IV catheter with a retracting needle to reduce accidental needle stick injuries. The safety feature (needle retraction) of this device is activated when | BD Insyte Autoguard may have potential damage along the body of the catheter. | accessdata.fda.gov |
| July 22, 2014 | 69047 | Class II | Terminated | BD PosiFlush SF Saline Flush Syringe 0.9 Sodium Chloride Injection, USP 10 mL REF 306553. Intended to be used only for the flushing of indwelling vascular access devices.10 mL BD PosiFlush Normal Saline Flush Syringes ar | BD received some reports of open seals found on the BD Posiflush SF Flush Syringe 10 mL (Ref #306553). | accessdata.fda.gov |
| July 3, 2014 | 68730 | Class II | Terminated | BD Vacutainer CPT Cell Preparation Tube with Sodium Heparin, 8 mL, 16 x 125 mm, Catalog #REF 362753, Lot #4063409 with expiry 03/2015, intended for the collection of whole blood and the separation of mononuclear cells. | BD has initiated the recall of its Vacutainer CPT Cell Preparation Tube due to poor separation, resulting in a reduced number of recovered mononuclear cells. | accessdata.fda.gov |
| November 26, 2013 | 67098 | Class II | Terminated | BD Interlink threaded lock cannula This is a locking blunt plastic cannula specifically designed for IV connection to an Interlink injection site. It is screwed down over the Interlink injection site and a blunt plastic | BD Interlink Threaded Lock Cannula REF# 303369 and lot #3021392 is being recalled due to the potential that a small percentage of the lot may exhibit open seals which adversely impacts unit package integrity and product sterility. | accessdata.fda.gov |
| August 23, 2013 | 66070 | Class II | Terminated | BD Epilor Syringe BD Franklin Lakes, NJ 07417 BD EDC Laagstraat 57, B-9140 Temse-Belgium The Epilor syringe is used in conjunction with an epidural needle with the purpose of finding the epidural space. | BD has received several reports indicating that the plunger of the 7 mL BD Epilor plastic BD Luer-Lok Loss of Resistance Syringe may stall or stick within the syringe preventing the user from detecting a loss of resistance upon entering the epidural space. | accessdata.fda.gov |
| July 10, 2013 | 66031 | Class II | Terminated | BD Microtainer Quikheel Lancet 1.0 mm incision Depth 2.5 mm Incision Length REF 368101 Rx Only Becton, Dickinson and Company, Franklin Lakes, NJ 07417 USA Made in USA. Used to perform heel sticks for the purpose of colle | The Lancet will not retract after activation thus creating a potential for exposure to a used sharp. | accessdata.fda.gov |
| May 1, 2013 | 65322 | Class II | Terminated | BD Vacutainer Multiple Sample and Direct Draw Luer Adapter BD Franklin Lakes, NJ 07417 USA A sterile non-invasive device used to connect venous access devices such as needles, blood collection sets, ad infusion sets to b | BD Vacutainer Multiple Sample and Direct Draw Luer Adapter may have blood leakage and low draw volume. | accessdata.fda.gov |
| May 1, 2013 | 65243 | Class II | Terminated | BD SafetyGlide Allergy. REF 305950 Sterile Allergy Treatment Syringe Tray. The device is used for aspiration and injection of medications. | There has been an increase in complaints regarding the needle/safety mechanism disengaging from the syringe. | accessdata.fda.gov |
| February 14, 2013 | 64494 | Class III | Terminated | BD Vacutainer C&S Transfer Straw Kit C&S Preservative Plus Urine Tube. 4.0 ml, 13 X 75 mm STERILE REF 364953. Becton Dickinson & Company, Franklin Lakes, NJ USA, The kit consists of a transfer straw and urinalysis tube i | The BD Vacutainer Urinalysis Transfer Straw Kit #364991, Lot 1335484 has preprinted polybags which are incorrectly labeled as Catalog #364953. BD advises any Customer who purchased this Kit that the Tube in this Kit is not a C&S tube. If a Customer relies solely on the polybag labeling and uses the Tube inside the Kit for the purpose of collecting urine for | accessdata.fda.gov |
| November 12, 2012 | 64010 | Class II | Terminated | BD Vacutainer Buffered Sodium Citrate (9NC) Plus Blood Collection Tubes; Sterile; IVD; REF 363083; 13 X 75 mm, 2.7 mL | BD is conducting a recall of the BD Vacutainer 2.7mL Plus Citrate Blood Collection Tube due to extended Partial Thromboplastin Time (aPTT) test results reported in two customer complaints. | accessdata.fda.gov |
| October 2, 2012 | 62394 | Class II | Terminated | Case Carton: BD Oral Dispensing Syringe 1 mL Clear with Tip Cap BD, Franklin Lakes, NJ 07417 USA Made in USA www.bd.com BD, Laagstraat 57, B-9140 Temse, Belgium On 100 unit plastic bag: BD oral syringes are intended to d | BD received a complaint report for mixed syringe tips (oral and non-oral syringe tips) within the same lot. | accessdata.fda.gov |
| March 5, 2012 | 64013 | Class III | Terminated | BD Vacutainer PST Gel and Lithium Heparin (LH); 83 Units; Plus Blood Collection Tubes; Sterile; IVD; REF 367962; 4.5 mL, 13 X 100 mm; BD, Franklin Lakes, NJ USA; Made in USA. Used in hospitals, outpatient clinics and phy | BD is conducting a recall of the BD Vacutainer Plus Plastic Plasma Separator Tube (PST) with Light Green/BD Homogard Closure due to a deformed top of the tube reservoir reported in two customer complaints. | accessdata.fda.gov |
| October 8, 2011 | 60988 | Not yet classified | Terminated | BD 30G1/2" Precision Glide" Needle Needles are used for aspiration and injection of medications | Becton Dickinson has identified clogged needles. | accessdata.fda.gov |
| October 5, 2011 | 61206 | Not yet classified | Terminated | BD Oral Dispensing Syringe Oral Syringe Tip Caps various sizes ( 1 mL, 3 mL, 5 mL. 10 mL BD, Franklin Lakes, NJ 07417 USA Made in USA www.bd.com Ref Numbers 305207, 305218, 305210, 305220, 305208, 305218, 305219 Product | There are complaint reports for loose tip caps in various types of oral syringes | accessdata.fda.gov |
| June 15, 2011 | 60255 | Not yet classified | Terminated | 1.0mL 28 G x 1/2" blister packaged insulin syringe Catalog Number 329424; Lot Number 0039920 Intended use: Subcutaneous injection of insulin. | Experiment labels may be on shelf cartons of 1.0ml 28G x 1/2 blister packaged insulin syringes. | accessdata.fda.gov |
| April 22, 2011 | 59218 | Not yet classified | Terminated | BD Vacutainer Push Button Blood Collection Set; REF 367324 Rx only, 23 G x 3/4" x 12 " (0.6 x 19 mm x 305 mm); BD Vacutainer Push Button Blood Collection Set without Multiple Sample Luer Adaptor, Sterile, Rx only, 21 G x | BD Vacutainer Push Button Blood Collection Set can potentially undergo cannula separation from the hub. | accessdata.fda.gov |
| March 1, 2011 | 58451 | Not yet classified | Terminated | BD Nokor Admix Needle 16 G x 1 TW (1.6mm x 25mm) REF 305216 Sterile BD, Franklin Lakes, NJ MADE IN USA For use in aspiration of medications, typically in the pharmacy setting. | Incorrect unit package labels which reflect Reorder #305216 instead of the correct item, Reorder #305213, were used. | accessdata.fda.gov |
| February 11, 2011 | 59684 | Not yet classified | Terminated | BD Microtainer MAP Microtube for Automated Process with K2EDTA. For the collection, transport, and automated processing of skin punctures samples from infants, children, geriatric, oncology, and critical care patients. | BD Microtainer MAP Microtube is being recalled due to the potential clotting of blood specimens resulting from a reduced amount of EDTA additive. | accessdata.fda.gov |
| October 5, 2010 | 56972 | Not yet classified | Terminated | BD Vacutainer Push Button collection Set; Non-Pyrogenic, Sterile, Rx only; 23 G x 3/4 x 12" (0.6 x 19 mm x 305 mm) Becton Dickinson & Co., Franklin Lakes, NJ, USA Intended use: Blood collection | There is the possibility for certain lots of the BD Vacutainer Push Button Blood Collection sets to have separation of the cannula from the hub. | accessdata.fda.gov |
| August 24, 2010 | 56663 | Not yet classified | Terminated | BD 30G1/2 PrecisionGlide Needle;Catalog/Lot Number: 305106. Needles are intended for use in aspiration and injection of medications. | There have been reports of blocked/clogged needles for the 30 gauge PrecisionGlide Needles | accessdata.fda.gov |
| November 23, 2009 | 53901 | Not yet classified | Terminated | BD 30 ml Syringe; Luer-Lok Tip Catalog # 309650 Becton Dickinson, Franklin Lakes, NJ. | Reports received of open seals on lot # 9175046, BD 30 ml Luer-Lok Syringes. This indicates product sterility may be compromised. | accessdata.fda.gov |
| October 12, 2009 | 53650 | Not yet classified | Terminated | BD Vacutainer Urine Cup Kit with C&S Preservative Tube for Midstream specimens; 50; Becton Dickinson and Company, Franklin Lakes, NJ 07417; Kit contains Sterile Screw-Cap collection cup with Integrated Transfer Device an | A small amount of discoloration was noted on Towelettes included in BD Vacutainer Urine collection kits. The entire kit components retain sterile interiors and no viable growth was detected on the towelettes. | accessdata.fda.gov |
| July 7, 2009 | 52601 | Not yet classified | Terminated | BD 60ml Syringe Luer-Lok tip, Sterile, BD, Franklin Lakes, NJ 07417, Made in USA. | Insufficient Seal: Becton Dickinson received complaints of insufficient/open seals on one lot of 60 ml Luer-Lok Syringes. | accessdata.fda.gov |
| April 30, 2009 | 52023 | Not yet classified | Terminated | BD 20 ml Syringe Luer-Lok Tip Sterile, Do not reuse; Catalog Number 309661. | Potential for compromised sterility: Insufficient packaging seals. | accessdata.fda.gov |
| November 24, 2008 | 50235 | Not yet classified | Terminated | BD 1 ml Integra TB Syringe with Retracting Precision Glide Needle; 1 ml 27 g 1/2 (0.4mm x 13 mm); Sterile; REF # 305298 BD, Franklin Lakes, NJ 07417. Made in USA Syringes for use in aspiration and injection of medication | Expiry date on the shelf carton is incorrect. It reads 2013-13, it should read 2013-03. | accessdata.fda.gov |
| July 15, 2008 | 49015 | Not yet classified | Terminated | BD 60 ml Syringe, Luer-Lok Tip Sterile; Cases : 160 (4 x 40) Shelf Carton: 40 BD; Franklin Lakes, NJ 07417 USA. Made in USA. Syringes for use in aspiration and injection of medications. | Becton Dickinson identified the presence of open seals during an internal inspection process. | accessdata.fda.gov |
| April 25, 2008 | 49086 | Not yet classified | Terminated | Ace Heat Therapy, A BD Product Up to 10 hours of Soothing Heat; Heat therapy for muscle and joint pain. Apply Directly to Skin, Instant, Air-Activated Heat Patches Distributed by: BD Medical, Franklin Lakes, NJ 07417 Cat | Potential for skin irritation and burns associated with the use of this product. | accessdata.fda.gov |
| January 7, 2008 | 46347 | Not yet classified | Terminated | BD 5 ml Syringe Luer Lok Tip Bulk Sterile Convenience Pak. Latex Free. Sterile. Reorder Number: 309703, BD, Franklin Lakes, NJ 07417. | Defective Seal: The convenience trays may have open seals, which can adversely impact tray sterility. | accessdata.fda.gov |
| November 20, 2007 | 45965 | Not yet classified | Terminated | BD Vacutainer Push Button Blood collection Sets with Pre-Attached Holder;Catalog Number : 367352: 21G x 3/4" x 12"; 0.8 x 19mm x 305mm, Wingset PBBCS, BD Diagnostics, Franklin Lakes, NJ | Safety Mechanism Failure: the safety mechanism of the BD Vacutainer Push Button Collection Set with Pre-attached holder cannot be activated; thus the needle cannot retract into the rear barrel. | accessdata.fda.gov |
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Updated May 29, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.