Data / Medical devices / United States / C.R. Bard, Inc.
C.R. Bard, Inc.: FDA-registered device maker in Covington, GA, United States, 73 510(k) clearances
C.R. Bard, Inc. is registered with the FDA (registration 1018233) in Covington, GA, United States. It lists 162 device types. The FDA files 73 510(k) clearances under its listings, the newest dated July 10, 2026. 66 recall events name it as the recalling firm (1 Class I). Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 1018233
- Address
- 8195 Industrial BLVD., Covington, GA, United States, 30014
- Owner or operator
- C. R. Bard, Inc. (2212754)
- Roles
- Complaint file establishment, Contract manufacturer, Contract sterilizer, Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- July 22, 1992
- Registered through
- 2027
- Brand names listed
- "J" Guidewires, & Foley Tray (I.C.), (Tieman Model) Coude Tip, 100cc Silicone Evacuator, 3-spring Y-connector, 30cc Balloon w/o Catheter, 4 Channel Monitor w/ Uroflow, 42-4012, Introducer Kit 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.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 10, 2026 | K253514 | Minnesota Four-Lumen Esophagogastric Tamponade Tube - 18 French (0092220); Blakemore Esophageal-Nasogastric Tube - 20 French (0092100); Blakemore Esophageal-Nasogastric Tube - 16 French (0092300) | KNT | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| May 29, 2026 | K254076 | BD Touchless Plus Unisex Pre-Lubricated Urethral Catheter Kit | FCM | Unknown | C.R. Bard, Inc. | accessdata.fda.gov |
| March 17, 2026 | K252971 | Elyra Thulium Fiber Laser System and Elyra Plus Thulium Fiber Laser System (Laser, Fibers, and Accessories) | GEX | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| February 23, 2026 | K251864 | Rubber Utility Catheter | KOD | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| May 15, 2025 | K251186 | Bard® Temporary Pacing Electrode Catheter Needle / Cannula (Introducer) | LDF | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| September 19, 2018 | K180781 | Bard Vertus Foley Catheter | EZL | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| September 20, 2017 | K172247 | Magic3 Go Intermittent Urinary Catheter | EZD | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| September 2, 2016 | K161602 | Arctic Sun Temperature Management System | DWJ | Substantially Equivalent | Medivance, Inc. | accessdata.fda.gov |
| March 31, 2016 | K160861 | Proxis Ureteral Access Sheath | FED | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| May 11, 2015 | K150345 | Magic3 Go Intermittent Urinary Catheter | EZD | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| December 18, 2014 | K142702 | Arctic Sun Temperature Management System, ArcticGel Pads (Universal, XXS, XS, S, M and L), Small Universal ArcticGel Pad, Neonatal ArcticGel Pad | DWJ | Substantially Equivalent | Medivance, Inc. | accessdata.fda.gov |
| May 9, 2014 | K133251 | BARD DIGNISHIELD STOOL MANAGEMENT SYSTEM | KNT | Unknown | C.R. Bard, Inc. | accessdata.fda.gov |
| July 27, 2012 | K120926 | ENDOBEAM HOLMIUM LASER FIBERS | GEX | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| April 1, 2011 | K101722 | ALYTE Y-MESH GRAFT | OTO | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| May 7, 2010 | K093747 | ALIGN AND ALIGN TO URETHRAL SUPPORT SYSTEMS | OTN | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| November 20, 2009 | K092607 | AJUST ADJUSTABLE SINGLE INCISION SLING | PAH | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| January 15, 2009 | K083839 | AVAULTA SOLO SYNTHETIC SUPPORT SYSTEM, AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM | OTP | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| October 23, 2008 | K080944 | X-FORCE NEPHROSTOMY BALLOON DILATION CATHETER | LJE | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| September 30, 2008 | K082571 | AVAULTA SUPPORT SYSTEM | OTP | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| December 7, 2007 | K070582 | BARDEX ALL-SILICONE, BARDEX LUBRI-SIL, AND BARDEX LUBRI-SIL I.C. TEMPERATURE-SENSING FOLEY CATHETERS | EZL | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| December 7, 2007 | K070558 | BARDEX LUBRI-SIL AND BARDEX LUBRI-SIL I.C. ANTI-INFECTIVE ALL-SILICONE FOLEY CATHETERS | EZL | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| November 6, 2007 | K071365 | AGENTO I.C. SILVER-COATED ENDOTRACHEAL TUBE | BTR | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| August 3, 2007 | K071341 | MODIFICATION TO ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 2000 | DWJ | Substantially Equivalent | Medivance, Inc. | accessdata.fda.gov |
| August 1, 2007 | K070201 | BARD INTRA-ABDOMINAL PRESSURE MONITORING DEVICE, MODEL IAP-001 | PHU | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| April 24, 2007 | K070879 | BARD MALECOT AND PEZZER DRAINS | FEW | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| March 21, 2007 | K070073 | ALIGN URETHRAL SUPPORT SYSTEM | OTN | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| March 12, 2007 | K063712 | AVAULTA SUPPORT SYSTEM/AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM | OTP | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| March 9, 2007 | K070508 | BARDEX LUBRI-SIL ALL-SILICONE LUBRICIOUS COATED FOLEY CATHETER 6 FR | EZL | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| January 5, 2007 | K063632 | X-FORCE N30 NEPHROSTOMY BALLOON DILATION CATHETER | LJE | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| May 26, 2005 | K050875 | U-BALLOON DILATION CATHETER | EZN | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| April 6, 2005 | K050688 | TEGRESS IMPLANT NEEDLE | FBK | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| December 7, 2004 | K043193 | BARD INLAYOPTIMA URETERAL STENT WITH SUTURE | FAD | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| November 9, 2004 | K042949 | PELVILACE TRANSOBTURATOR BIOURETHRAL SUPPORT SYSTEM (PELVILACE TO SYSTEM) | PAG | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| September 29, 2004 | K040658 | BARDEX I.C. LATEX FOLEY CATHETER | MJC | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| June 10, 2004 | K033477 | HYDROPHILIC-ANTIBACTERIAL INTERMITTENT CATHETER, INTERMITTENT CATHETER CLOSED SYSTEM KIT | MJC | Substantially Equivalent | Rochester Medical Corp. | accessdata.fda.gov |
| May 14, 2004 | K040504 | BARDEX, LUBRI-SIL AND LUBRI-SIL IC ALL-SILICONE FOLEY CATHETERS | EZL | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| February 4, 2004 | K033719 | BARD TIGERTAIL URETERAL CATHETER | KOD | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| January 9, 2004 | K033830 | OPTION-VF URINARY CATHETER WITH ADAPTOR, MODEL FVA14218; OPTION-V CONTINUOUS DRAINAGE ADAPTOR, MODEL CDA1000 | EZL | Substantially Equivalent | Opticon Medical, Inc. | accessdata.fda.gov |
| December 30, 2003 | K033778 | MODIFICATION TO BARD AQUAGUIDE URETERAL CONDUIT | FED | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| November 14, 2003 | K032521 | BARD DUAL LUMEN URETERAL CATHETER | EYB | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| May 20, 2003 | K030518 | AMERITEK SURE-POINT TRACKER SYSTEM | ITX | Substantially Equivalent | Amertek Medical, Inc. | accessdata.fda.gov |
| May 15, 2003 | K031332 | BARD PELVISOFT ACELLULAR COLLAGEN BIOMESH | FTM | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| May 15, 2003 | K031295 | BARD INNERLACE BIOURETHRAL SUPPORT SYSTEM | PAG | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| July 7, 2000 | K001143 | RELEASE NF ANTIBACTERIAL FOLEY CATHETER, ANTIBACTERIAL PERSONAL CATHETER | MJC | Substantially Equivalent | Rochester Medical Corp. | accessdata.fda.gov |
| May 19, 2000 | K000723 | HYDROPHILIC SILICONE FOLEY CATHETER AND PERSONAL CATHETER (HYDROPHILIC AND NON-HYDROPHILIC) | KOD | Substantially Equivalent | Rochester Medical Corp. | accessdata.fda.gov |
| January 31, 2000 | K993840 | BARD UROFORCE BALLOON DILATION CATHETER | EZN | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| December 10, 1999 | K993464 | BARDEX I.C. PEDIATRIC FOLEY CATHETER | MJC | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| February 16, 1999 | K984136 | BARDEX LUBRI-SIL I.C. FOLEY CATHETER | MJC | Substantially Equivalent | Bard Medical Div. | accessdata.fda.gov |
| February 1, 1999 | K984084 | BARDEX LUBRI-SIL FOLEY CATHETER | EZL | Substantially Equivalent | Bard Medical Div. | accessdata.fda.gov |
| December 15, 1998 | K983498 | BARD INLAY LUBRICIOUS DOUBLE PIGTAIL URETERAL STENT WITH SUTURE (HEREINAFTER REFERRED TO AS BARD LUBRICIOUS URETERAL STE | FAD | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| November 3, 1998 | K983101 | BARDEX I.C 4-WAY FOLEY CATHETER MODEL 1865SIXX XX = 18,20,22,24 | MJC | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| August 15, 1997 | K972152 | DEVMED STEPPING AND STABILIZING SYSTEM | ITX | Substantially Equivalent | Devmed Corp. | accessdata.fda.gov |
| December 17, 1996 | K962538 | BARD COAGULATING RESECTOR MODEL (3552XX; XX=01,02,03,04,05 OR 06) | FAS | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| October 9, 1996 | K961841 | BARD V-MAX ROLLER BAR (3551XX;XX=01,02,03,04,05, OR 06) | FAS | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| July 24, 1996 | K960176 | DAVOL NASOGASTRIC SUMP TUBE W/PREVENT FILTER | FEG | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| September 27, 1995 | K951260 | URINARY INTERMITTENT CATHETERS W/O HYDROMER HYDROPHILIC LUBRICANT | KOD | Substantially Equivalent | Biosearch Medical Products, Inc. | accessdata.fda.gov |
| April 28, 1995 | K951103 | SILASTIC BRAND FOLEY CATHETER | EZL | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| August 18, 1994 | K910318 | BARD(R) HYDROGEL/SILVER-COATED FOLEY CATHETER | MJC | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| September 21, 1993 | K924714 | BARD URODYNAMIC CATHETER | FEN | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| March 25, 1993 | K922431 | BARD LATEX URINARY CATHETERS | KOD | Unknown | C.R. Bard, Inc. | accessdata.fda.gov |
| January 27, 1992 | K913341 | BARD(R) COUDE TIP TEMPERATURE SENSING CATHETER | EZC | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| August 16, 1991 | K910846 | BARD LATEX URINARY CATHETERS DRAINS- DESIGNS MODIF | EZC | Unknown | C.R. Bard, Inc. | accessdata.fda.gov |
| August 9, 1991 | K910197 | HYDROGEL-COATED URETHRAL CATHETERS AND DRAINS | EZC | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| August 9, 1991 | K910195 | BARD HYDROGEL-COATED FOLEY CATHETERS | EZC | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| May 6, 1991 | K910653 | TOUCHLESS II INTERMITTENT CATHETER | FCM | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| April 30, 1991 | K903345 | BARD (R) LUBRICIOUS - COATED URETERAL STENT SUTURE | FAD | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| April 9, 1991 | K905102 | BARD(R) SYRINGE ASSIST IRRIGATION | OCX | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| May 27, 1983 | K823487 | BARD URETERAL STENT | FAD | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| June 24, 1982 | K821745 | BARDEX ALL SILICONE PEDIATRIC CATHETER | KOD | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| November 12, 1980 | K802665 | TOUCHLESS CLEAN-CATH | KOD | Substantially Equivalent | Diamed Division Ill. Tool Works, Inc. | accessdata.fda.gov |
| April 16, 1980 | K800298 | USCI BIPOLAR BALLON PACING ELECTRODE | LDF | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| October 18, 1977 | K770814 | CATHETER, URETHERAL | KOD | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| August 23, 1976 | K760093 | CATHETER, SILICONE FOLEY (BARDEX) | GBM | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| June 25, 2026 | 98840 | Class II | Ongoing | Products that contain the Pericare Wipes: Bardex Lubricath Foley Catheter Tray REF: 899914 899916 899918 UDI codes: 00801741024801 10801741024808 00801741024818 10801741024815 00801741024825 10801741024822 SureStep" Fole | Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermittent Catheter Trays. | accessdata.fda.gov |
| April 23, 2026 | 98716 | Class II | Ongoing | Silastic Foley Catheters Silastic Brand Foley Catheter 30cc REF: 33416 33418 33420 33422 33424 Silastic Brand Foley Catheter 5cc REF: 33614 33616 33618 33620 33622 33624 | Due to stain present on the surface of affected foley catheters. | accessdata.fda.gov |
| November 6, 2025 | 97985 | Class II | Ongoing | Bard InLay Optima Size: 6 Fr. x 14 cm, Ureteral Stent Kit REF 787614 | Labeling discrepancy; Ureteral stent actual size may not match the actual product label. | accessdata.fda.gov |
| July 17, 2025 | 97273 | Class II | Ongoing | SureStep Foley Tray System Bardex I.C. Complete Care Infection Control Foley Catheter Tray, REF: A303316A | Foley catheter trays have incorrect inserts, user may think:1)Silicone, when it's natural rubber latex, or 2)Natural rubber latex with infection control coating, when it's silicone hydrogel with antimicrobial coating, or 3)Natural latex with infection control, when it's silicone hydrogel coated without antimicrobial coating, which may cause infection and/or | accessdata.fda.gov |
| June 18, 2025 | 97041 | Class II | Ongoing | Bardex Lubri-Sil I.C. 400-series Temperature Sensing Silver/Hydrogel Coated All-Silicone Foley Catheter 5cc Balloon, REF: 119314; SureStep Foley Tray System Lubri-Sil I.C. Complete Care, REF: A319514A; Bard Silver Lubri- | Foley catheter may have an obstructed lumen, which may result in an inability to drain the bladder, of urine and may include pelvic or abdominal pain, flank pain, bladder dysfunction, obstructive uropathy, acute kidney injury and/or hydronephrosis. | accessdata.fda.gov |
| June 3, 2025 | 96961 | Class II | Ongoing | BD Heyman Follower Straight Tip for following sizes: 10Fr - REF:21110, 12Fr - REF:21112, 14Fr - REF: 21114, 20Fr - REF: 21120 | Cather packaging may contain the incorrect French size. | accessdata.fda.gov |
| April 17, 2025 | 96645 | Class I | Ongoing | Bard Minnesota Four Lumen Esophagogastric Tamponade Tube, REF:0092220 18 Fr. (6mm, 7/32"), 41" Length (104cm) with 8" (20.3cm) Balloon X-Ray Opaque Rubber | Due to customer complaints, there is a potential for users to be unable to or find it difficult to remove the plastic plugs in order to inflate the gastric and/or esophageal balloons. | accessdata.fda.gov |
| May 9, 2024 | 94722 | Class II | Ongoing | Bard Medical SureStep Foley Tray System, 16 Fr., Catalog #A319416AM; and Bard Medical Bardex IC Complete Care Infection Control Temperature-Sensing Foley Catheter Tray with Bard Hydrogel and Bacti-Guard Silver Alloy Coat | Some of the devices may function incorrectly resulting in no temperature display or erratic temperatures being displayed on the temperature monitoring devices. | accessdata.fda.gov |
| December 20, 2023 | 93679 | Class II | Ongoing | Bard Nasogastric Sump Tube with ENFit, 10Fr., 36in Long, REF EN0042100 | BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred. | accessdata.fda.gov |
| November 15, 2023 | 93375 | Class II | Ongoing | Sensica Urine Output System, Catalog Number SCCS1002 | BD (C.R. Bard) has received user complaints reporting that when the device was connected to WiFi/Internet, the time displayed on the Sensica device changed during a patient monitoring session which resulted in 1) incorrect time displayed on the monitoring screen, 2) incorrect hour block timestamps on the monitoring screen, 3) incorrect hour timestamps on dat | accessdata.fda.gov |
| April 20, 2023 | 92082 | Class II | Ongoing | Magic3 Go Intermittent Urinary Catheters, Female Catalog Numbers: a) REF 51808, b) REF 51810, c) REF 51812, d) REF 51814, e) REF 51816, f) REF 51818 | Some catheters had a manufacturing defect where the clear resealing label separating from the product foil pouch, resulting in a possible opening into the product packaging that could impact product sterility. | accessdata.fda.gov |
| May 19, 2022 | 90251 | Class II | Ongoing | Sensica Urine Output System | Complaints relating to urine output measurement accuracy. | accessdata.fda.gov |
| January 27, 2022 | 89288 | Class II | Terminated | BARD SURESTEP INTERMITTENT CATHETER TRAY, 14Fr, REF INTS14C | There is a potential to leak from the catheter where it connects to the drain bag | accessdata.fda.gov |
| August 5, 2021 | 88499 | Class II | Ongoing | Catalog A119216M, SureStep" Foley Tray, Lubri-Sil", Urine Meter, Temperature Sensing Dual, StatLock" Stabilization Device | There is potential for packaging defects that may impact the sterile barrier. | accessdata.fda.gov |
| January 11, 2021 | 87163 | Class II | Terminated | Bard Clean-Cath Intermittent Catheter, 12 French female length (catheter, urological) - Product Usage: for urological use only. | The device catheter tip was cut off (no tip) and the product packaging was not fully sealed. | accessdata.fda.gov |
| April 15, 2020 | 85585 | Class II | Terminated | SureStep Foley Tray System - Product Usage: Intended for use in the drainage and/or collection and/or measurement of urine. Generally, drainage is accomplished by inserting the catheter through the urethra and into the b | There is potential for a white paper-type residue attached to the catheter. | accessdata.fda.gov |
| January 13, 2020 | 84744 | Class II | Terminated | The Bard Intra-abdominal Pressure Monitoring Device is composed of a tubing set used for infusing fluid into the urinary bladder through the Foley catheter sampling port. It utilizes a clamping device to occlude the urin | Leaks or disconnect near the sampling port of the Intra Abdominal Pressure Monitoring Device which could lead to the potential of inaccurate readings. The measurement should be confirmed with other means, such as a new IAP system of the same kind or by choosing other diagnostic means such as but not limited to alternative systems, such as open IAP measuremen | accessdata.fda.gov |
| December 13, 2018 | 81889 | Class II | Terminated | SureStep(TM) FOLEY TRAY SYSTEM, Preconnected Closed System Foley Tray, Product Codes: A119214M, A119216M, A119218M, A119416M, A153200, A300916A, A301216, A301216A, A303314A, A303316A, A303318A, A303414A, A303416A, A30341 | potential for urine leakage around the vent on the vented sample port | accessdata.fda.gov |
| December 6, 2018 | 81750 | Class II | Ongoing | BARD SureStep Foley Tray System Bardex I.C. Complete Care Temperature Sensing Infection Control Foley Catheter with Bard Hydrogel and Bacteria-Guard Silver Alloy Coating. Sterile. Intended for use in the drainage and/or | Some SureStep" Foley Tray Systems with product catalog number A319418AM and lot number NGCT1929 contain vented sample ports that may have an increased likelihood of leaking urine from the vent on the sample port. | accessdata.fda.gov |
| June 13, 2018 | 80375 | Class II | Terminated | Arctic Sun Temperature Management System, Model 5000. The Arctic Sun 5000 model is a non-invasive, thermal regulating system, indicated for monitoring and controlling patient temperature within a range of 32C to 38.5C (8 | An improper wiring connection on the chiller assembly may result in overheating of the connection and potential failure of certain components in the system. | accessdata.fda.gov |
| March 21, 2018 | 80624 | Class II | Terminated | Bard Midstream Urine Collector with Rigid Funnel and Iodophor Prep Pads. Product Packaging: Three (3) PVP-I prep pads are packed into each urine collection kit carton along with a pre-connected drainage funnel, specimen | Medline notified BMD that the Aplicare Povidone Iodine (PVP-I) Prep Pads were not meeting the iodine assay level requirements to support 36 month expiration dating. | accessdata.fda.gov |
| February 27, 2018 | 79507 | Class II | Terminated | Bard(R) Premature Infant Feeding Tube, ENFit(TM), REF EN0036400 Product Usage: BARD(R) Nasogastric Sump Tubes with ENFit(TM) connector are intended to be used for: Decompression of stomach by suction or aspiration of gas | BMD has identified that the product code/lot number combination identified above may have ineffectively fused tubing and ENFit(TM) connector. | accessdata.fda.gov |
| December 13, 2017 | 80150 | Class II | Terminated | Bardex Lubricath 3-Way 75cc Continuous Irrigation Foley Catheter (Creevy), 22Fr. Rx (01267522) | Foley Catheter with Incorrect Retainer Cap Print | accessdata.fda.gov |
| November 10, 2017 | 80085 | Class II | Ongoing | CritiCore Automated Urine Output and Temperature Monitor | Issues identified with the monitor including urine output measurement errors, temperature measurement errors and undesired alarms. | accessdata.fda.gov |
| November 10, 2017 | 78622 | Class II | Terminated | BARD(R) CRITICORE(R) MONITOR, Model: 000002N Series The CritiCore(R) Automated Urine Output and Temperature Monitor is indicated to monitor urine output and core bladder temperature. | BMD has identified that some lots of CritiCore(R) monitors may experience failures involving urine output volume measurement fluctuations, core bladder temperature measurement fluctuations and alarm errors. | accessdata.fda.gov |
| November 8, 2017 | 82450 | Class II | Terminated | Medivance(R) ARCTIC SUN(R) ARCTICGEL(TM) Pads: Description, Catalog Number a) Intrepid ArcticGel Small Pad Kit, 31705I b) Intrepid ArcticGel Medium Pad Kit, 31707I c) Intrepid ArcticGel Large Pad Kit, 31709I d) Intrepid | Specific lots of ArcticGel Pads have potential issues which may result in the insufficient adhesion of the hydrogel to the pad. | accessdata.fda.gov |
| October 16, 2017 | 78664 | Class II | Terminated | Medivance ArcticGel Small Pad Kit - a box containing a single foil pouch, which contains a set of four (4) pads. A set of pads comprise a left and a right torso pad, and a left and a right thigh pad. Is a Thermal regulat | Hydrogel peeling from the pads. | accessdata.fda.gov |
| September 29, 2017 | 78231 | Class II | Terminated | BARD UROS AUTOMATED URINE OUPTUT AND TEMPERATURE MONITOR, MODEL BK10001M The Uros(TM) Automated Urine Output and Temperature Monitor is indicated to monitor urine output and core bladder temperature. | The possibility exists that use of the Uros Automated Urine Output and Temperature Monitor may lead to the loss of urine output measurement data and/or urine output measurement inaccuracies resulting in an impact on clinical treatment decisions. | accessdata.fda.gov |
| September 14, 2017 | 78642 | Class II | Terminated | HydroSil Gripper Intermittent Catheters- 10" lengths - 30 catheters per box, each catheter is packaged in an individual pouch. MGC3 Product Usage Intermittent catheters are intended for urinary bladder drainage in patien | Several instances of a catheter caught in the sterile barrier seal and in some instances cut catheters were observed. | accessdata.fda.gov |
| July 28, 2017 | 78031 | Class II | Terminated | Bard Magic 3 Antibacterial Hydrophilic Intermittent Catheter Female, 14 FR (30/box), Rx Only intended for urinary bladder drainage in patients requiring catheterization for management of incontinence, voiding dysfunction | Specific lots labeled as an Antibacterial Hydrophilic Intermittent Catheter may lack the hydrophilic coating. | accessdata.fda.gov |
| June 2, 2017 | 77733 | Class II | Terminated | BARD DISPOZ-A-BAG Leg Bag with Flip-Flo Valve with Drain Extension, Extension Tube and Latex Straps, 19 oz. Packaged as single unit in thermoformed trays. There are 50 units per case. Product Usage: Vinyl leg bag to be u | Customer complaint of a cut in the side of the leg bag, indicating a potential breach of the product's sterile barrier. | accessdata.fda.gov |
| June 2, 2017 | 77469 | Class III | Ongoing | Arctic Sun ArcticGel Pads - Medium, Product Code 317-07 | Label on product box contains the incorrect reference #317-09 while the shelf box label with barcode and the internal foil pouch label are correctly labeled with product code 317-07 and lot number NDAR0462. | accessdata.fda.gov |
| March 31, 2017 | 77794 | Class II | Ongoing | Arctic Sun 5000 Temperature Management System, V North America and V US | Potential failure of the Arctic Sun 5000 Temperature Management System may occur when the continued use is in excess of 2000 system hours without preventive maintenance. | accessdata.fda.gov |
| March 9, 2017 | 76775 | Class II | Completed | SURESTEP Tray, Bardex I.C. Complete Care Drainage Bag, 2000 ml Drainage Bag, 16 Fr., Sterile. | Misbranded: Product labeled, Not made with natural rubber latex, may in fact contain natural rubber latex. | accessdata.fda.gov |
| December 9, 2016 | 77439 | Class II | Terminated | I-125 CE Marked QuickLink Cartridges; Sterile; Bard Brachysource Radioactive Seeds in QuickLink Cartridges Indicated for permanent interstitial treatment of selected localized tumors such as: head and neck, lung, pancrea | Activity and quantity of seeds sent in shipments were incorrect. | accessdata.fda.gov |
| October 13, 2016 | 75492 | Class II | Terminated | Bard Fluoro-4 Silicone Ureteral Stent, Bard Fluoro-4", Silicone Ureteral Coil Stent; Bard Silicone Uretera l Coil Stent with Figure Four, End, Manufacturer: C.R. Bard, Inc., Covington, GA 30014. | Labeling: Statement was added to the Warnings/Precautions section requesting end users to consider the presence of a knot if significant resistance is encountered during attempts at removal. | accessdata.fda.gov |
| October 12, 2016 | 75452 | Class II | Terminated | X-Force Nephrostomy Balloon Dilation Catheter Kit with Inflation Device, PTFE Sheath, 8 mm x 15 cm, Product Code 996081 The product is a dual lumen catheter with a 24 (8mm) or 30Fr (10mm) balloon mounted on the distal ti | Contract manufacturer packaged an incorrect sheath with the product. Packaged 30Fr instead of 24Fr. | accessdata.fda.gov |
| October 12, 2016 | 75428 | Class II | Terminated | C-Max" Cutting Loop Electrodes, Storz One-Stem, 24 Fr,.014in.,.35 mm, Sterile, Rx only, Manufactured by: C.R. Bard, Inc., Covington, GA 30014. | Defect; The contact part could possibly separate from the electrode affecting to functionality of the device. | accessdata.fda.gov |
| October 5, 2016 | 75365 | Class II | Terminated | Magic3 Antibacterial Hydrophilic Intermittent Catheter, Male 14 Fr. (30/Box), Sterile Product Usage: The catheter is an all silicone, single lumen, drainage tube with drainage eyes at the proximal end and a tapered funne | Misbranding; the product labeled as an Antibacterial Hydrophilic Intermittent Catheter, is instead an Antibacterial Intermittent Catheter (no Hydrophilic Coating). | accessdata.fda.gov |
| August 3, 2016 | 75469 | Class II | Terminated | BARD Irrigation, Syringe 70cc With Resectoscope Tip, Catheter Tip, Luer Adapter And Cap, Rx Only, Sterile, The BARD Syringe is available in a single use plastic design which features a 60cc or 70cc capacity graduated bar | Package Defect: Products may be at risk for having a slit defect on the package and that may affect the product sterility. | accessdata.fda.gov |
| July 11, 2016 | 75952 | Class II | Terminated | SURESTEP Tray, BARDEX I.C. COMPLETE CARE, Urine Meter, Temperature STATLOCK Stabilization Device | The product contained a latex catheter instead of a silicone catheter. | accessdata.fda.gov |
| July 11, 2016 | 74712 | Class II | Terminated | Option-vf Urinary Catheter. Female use only. Latex Free. Sterile, Rx only. | During an FDA inspection it was found out that the Practical Foley Catheters to be potentially nonsterile. | accessdata.fda.gov |
| June 30, 2016 | 74609 | Class III | Terminated | Medivance ArcticGel Neonatal Pad The pad is designed to fit into an incubator and provide whole body cooling for patients. | An internal review of an available product found that the Information For Use only contained English and Japanese languages when a CE-marked 23 language version was expected. | accessdata.fda.gov |
| June 29, 2016 | 74610 | Class III | Terminated | SureStep Tray, with Add-a-Foley, COMPLETE CARE, Drainage Bag, and STATLOCK Stabilization The product is a urine collection system that includes a STATLOCK Foley Stabilization Device | Labeling problem | accessdata.fda.gov |
| March 4, 2016 | 73454 | Class II | Terminated | BARD ArcticGel Pads Product Usage: The Arctic Sun Temperature Management System is intended for monitoring and controlling patient temperature. ArcticGel Pads are only for use with an Arctic Sun Temperature Management Sy | Complaints were received of restricted/inaccurate flow rate. | accessdata.fda.gov |
| January 4, 2016 | 72977 | Class III | Terminated | REF 0038460 Toomey Syringe 70cc Syringe with Catheter Tip and Luer Tip Adapters, Single Use, Rx Only, Latex Free, 50 units. Product Usage: Product is intended for Resectoscope irrigation, catheter irrigation and Foley ca | Report by a customer of an open package seal. | accessdata.fda.gov |
| December 18, 2015 | 72922 | Class II | Terminated | BARDEX I.C. Anti-Infective 2-Way 3cc Foley Catheter, Rx only. Intended for urinary bladder drainage in female patients requiring catheterization for management of incontinence, voiding dysfunction and surgical procedure. | Labeling error: Catalog contains Instructions for Use (IFU) error; incorrect inflation volume. | accessdata.fda.gov |
| November 10, 2015 | 72756 | Class II | Terminated | Arctic Sun 5000 and Arctic Sun 2000; Intended for monitoring and controlling patient temperatures. | Improper targeted temperature therapy was delivered to patients because the Temperature Simulator Key was connected to the patient temperature cable instead of the patient temperature probe. | accessdata.fda.gov |
| November 9, 2015 | 73827 | Class II | Terminated | Arctic Sun Temperature Management System, 5000, 100-120V and 220-240V The product is a thermal regulating system indicated for monitoring and controlling patient temperature | The product may contain electronic components that lead to a premature drainage of the internal control panel coin cell battery responsible for maintaining the system close and Static Random Access Memory (SRAM). This premature coin cell battery drainage could render the device unresponsive upon System startup. | accessdata.fda.gov |
| October 2, 2015 | 72398 | Class III | Terminated | Antibacterial Hydro Personal Catheter, Male 12 Fr, Product Code 63512, sold in boxes of 30 units | Incorrect unit labeling. The case label and shelf box are correct, Product Code 63512 and Catheter Size 12 French. The unit label (catheter package) may state Product Code 63516 and Catheter Size 16 French. | accessdata.fda.gov |
| August 24, 2015 | 72024 | Class II | Terminated | Magic3 Intermittent Catheter with Sure Grip Hydrophilic Coated Silicone Coude tip, Product Code 50614. The catheters are packaged in film-to-film pouches and packaged 30 per box. Used as an Intermittent Urinary Catheter | Potential breach of the sterile barrier packaging. | accessdata.fda.gov |
| July 7, 2015 | 71722 | Class II | Terminated | Magic3 Hydrophilic-coated Female Intermittent Urinary Catheters (6"), 10 Fr, (30/box), Product Code 51610. Intermittent catheter. | Potential breach of the sterile barrier packaging. | accessdata.fda.gov |
| January 30, 2015 | 70666 | Class II | Terminated | Bard 100% Latex-Free Urinary Drainage Bag with Anti-Reflux Chamber and Bard EX-Lok Sampling; Product Code 154006: Lot # NGYJ0603 and NGYJ1671 | Potential breach of the sterile barrier packaging. | accessdata.fda.gov |
| October 7, 2014 | 69462 | Class II | Terminated | Bard Dimension Stone Basket Product Usage: The Bard Dimension Stone basket is a teardrop-shaped basket with the ability to capture stones by, opening and closing the basket and articulating or moving the basket from side | The product is non-sterile. | accessdata.fda.gov |
| September 7, 2012 | 63136 | Class II | Terminated | 8 Fr. Bardex Pediatric All-Silicone Foley Catheter with a 3cc balloon. The product is packaged individually with 12 units per corrugated case. The product is sold sterile for single use and is used to provide continuous | The 8 Fr. Bardex All-Silicone Foley Catheter with 3cc balloon had an incorrect inflation volume (10 ml instead of 5 ml) printed on the valve cap. | accessdata.fda.gov |
| June 29, 2012 | 62774 | Class II | Terminated | Bard Foley procedural trays packaged in breather bags. The product is packaged ten units in each shipper box, and are sold sterile for single use. Used to catheterize patients. The finished trays are sold in Tyvek breath | Incomplete seal on sterile packages of product. | accessdata.fda.gov |
| November 17, 2010 | 57291 | Not yet classified | Terminated | Bard CritiCore Monitor, Software Version 2.1, Catalog number 000002N, C.R. Bard, Inc., Covington, GA 30014. Intended for multiple uses as it is an electronic battery-operated monitor used in conjunction with a single-use | Error can occur in the reading of the Present Interval Output (PIO) reading when the device is subjected to bumping or forceful replacement of the fluid container. | accessdata.fda.gov |
| October 28, 2010 | 57117 | Not yet classified | Terminated | Bard Rectal Tubes, 22 French, 20 Long (51 cm), X-Ray Opaque Rubber with Funnel end, Open Tip, One Eye, Non sterile, 12 Each, C.R. Bard, Inc., Covington, GA 30014 | The product is misbranded. The product is labeled as 22 French, however the product is actually 20 French. | accessdata.fda.gov |
| April 2, 2009 | 52046 | Not yet classified | Terminated | Bard StatLock Intravenous (IV) Catheter Stabilization Kit, Catalog number: IVK0124, C.R. Bard, Inc., Covington, GA 30014, USA. | The affected units may contain extension sets with the microbore tubing instead of extension sets with the macrobore tubing. | accessdata.fda.gov |
| November 3, 2005 | 34037 | Not yet classified | Terminated | Bard UroForce Balloon Dilation Catheter with Glissando Coating * BARD * C.R. Bard, Inc. Covington, Georgia 30014 * * Sterile/EO | There is a potential for the lumen to collapse and prevent passage over a guidewire. | accessdata.fda.gov |
| September 28, 2005 | 33780 | Not yet classified | Terminated | Bard RespiShield * Closed Suction System with InnoValve * Endotracheal Start Kit * QTY 1 Unit * 14F/4.7mm * Sterile * Rx Only * C.R.Bard, Inc., Covington, GA 30014,, www. bardmedical.com * Manufactured in Mexico. | Varying degrees of difficulty were encountered when opening and closing the InnoValve. | accessdata.fda.gov |
| August 17, 2005 | 33284 | Not yet classified | Terminated | Bard * Davol Reliavac 400 Closed Wound Suction Kit * Sterile/EO * Single use * Medium-Large 3/16'' (15 Fr., 4.7mm) O.D. PVC Drain * 12.5'' (31.7cm) Hole Pattern, X-ray Opaque Stripe Attached Trocar * 400cc Evacuator ** Y | An incorrect Y-connector was placed in the kit. | accessdata.fda.gov |
| February 10, 2004 | 28310 | Not yet classified | Terminated | BardiaComplete Foley Kit, Single use only, Do not resterilize, For urological use only, Reorder: 800518, 18 Fr., Lot 76IN0317, Inflate with 10ml sterile water, Contents: 5cc Silicone Elastomer-Coated Foley Catheter, Wate | The Foley trays contain a 16 French catheter instead of an 18 French catheter as specified by the product insert/labeling. | accessdata.fda.gov |
| December 22, 2003 | 28010 | Not yet classified | Terminated | Bard Dimension Stone Basket, Rx only, Sterile, C.R.Bard, Inc., Covington, GA 30014 | Product packaging may contain holes compromising sterility. | accessdata.fda.gov |
| March 25, 2003 | 25894 | Not yet classified | Terminated | Bard Dispoz-A-Bag, Disposable Urinary Leg Bags, with Flip-Flo Drainage Valve, 19 oz or 32 oz with a Fabric Leg Strap, C.R.Bard, Inc., Covington, GA 30014, Contents Sterile. | There is a potential for package seals to be open after sterilization. | accessdata.fda.gov |
| August 29, 2002 | 26828 | Not yet classified | Terminated | Bardex Foley Catheter, 22 Fr 40cc- 20cc Ribbed Balloons, Coleman Model Red Latex, 3 Way Radiopaque, Lubricath Coated, Sterile, Single Use Device, C.R. Bard, Inc., Covington, GA 30014. The catheter is an open whistle tip | On some units the inflation valve labeling is reversed on the Prostate and Bladder balloon inflation ports. | accessdata.fda.gov |
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Updated September 4, 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.