Data / Medical devices / United States / Carefusion 2200, Inc.
Carefusion 2200, Inc.: FDA-registered device maker in Vernon Hills, IL, United States, 157 510(k) clearances
Carefusion 2200, Inc. is registered with the FDA (registration 1423507) in Vernon Hills, IL, United States. It lists 64 device types. The FDA files 157 510(k) clearances under its listings, the newest dated February 25, 2026. 18 recall events name it as the recalling firm (2 Class I). Registered through 2027. FDA data exported November 3, 2026.
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- FDA registration number
- 1423507
- FEI number
- 3008002452
- Address
- 75 North Fairway Drive, Vernon Hills, IL, United States, 60061
- Owner or operator
- CAREFUSION (10030506)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- October 12, 2009
- Registered through
- 2027
- Brand names listed
- 42-4012, Introducer Kit, 42-4016, Introducer Kit, Alcohol Swab, AvaMax, Axillary Block Needle, BD 1mL Luer-Lok" Hypodermic Syringe, BD 27G and 29G Spinal Needles, BD Alaris Infusion Set 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 157.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 25, 2026 | K253996 | BD Surgiphor Antimicrobial Irrigation System (910110) | FQH | Substantially Equivalent | Becton, Dickinson and Company (BD) | accessdata.fda.gov |
| February 20, 2026 | K253445 | BD Surgiphor 1000 mL Antimicrobial Irrigation System (910120) | FQH | Substantially Equivalent | Bd | 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 |
| October 30, 2025 | K250325 | BD Alaris Pump Infusion Set | FPA | Substantially Equivalent | Carefusion (Bd) | accessdata.fda.gov |
| October 8, 2025 | K251422 | BD Saf-T-Intima Subcutaneous Catheter System | FOZ | Substantially Equivalent | Becton Dickinson Infusion Therapy Systems, Inc. | 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 25, 2025 | K243403 | BD Nexiva Closed IV Catheter System | FOZ | Substantially Equivalent | Becton Dickinson Infusion Therapy Systems, Inc. | accessdata.fda.gov |
| July 11, 2025 | K251155 | BD Cathena Safety IV Catheter | FOZ | Substantially Equivalent | Becton Dickinson Infusion Therapy Systems, Inc. | accessdata.fda.gov |
| June 27, 2025 | K251654 | BD Insyte Autoguard Shielded IV Catheter, BD Insyte Autoguard BC Shielded IV Catheter and BD Insyte Autoguard BC Pro Shielded IV Catheter | FOZ | Substantially Equivalent | Becton Dickinson Infusion Therapy Systems, Inc. | accessdata.fda.gov |
| June 3, 2025 | K250682 | BD Nexiva Diffusics Closed IV Catheter System and BD Nexiva Diffusics Closed IV Catheter System with BD MaxZero Needle-free Connector | FOZ | Substantially Equivalent | Becton Dickinson Infusion Therapy Systems, Inc. | accessdata.fda.gov |
| December 6, 2024 | K241946 | PeritX 1L Drainage Kit (90-1010); PeritX 2L Drainage Kit (90-2010); PeritX Peritoneal Catheter Kit (50-9000C); PeritX Peritoneal Catheter and Starter Kit (50-9900C); PeritX Peritoneal Catheter Mini Kit (50-9050A); PleurX Low Profile Catheter Mini Kit (50-8050); Valve Cap (50-7235A); PeritX Valve Kit (50-7272); Catheter Access Kit (50-7280A); Lockable Drainage Line (50-7245A); Lockable Drainage Line Kit (50-7265A); PleurX Supplemental Insertion Kit (50-7262); Procedure Pack (50- | PNG | Substantially Equivalent | Bard Peripheral Vascular, Inc. | accessdata.fda.gov |
| March 6, 2024 | K233021 | BD SmartSite 13mm Vial Access Device; BD SmartSite 20mm Vial Access Device | LHI | Substantially Equivalent | Care Fusion | accessdata.fda.gov |
| December 1, 2023 | K233529 | BD Nexiva Diffusics Closed IV Catheter System with BD MaxZero Needle-free Connector | FOZ | Substantially Equivalent | Becton Dickinson Infusion Therapy Systems, Inc. | accessdata.fda.gov |
| September 28, 2023 | K230865 | PIVO Pro Needle-free Blood Collection Device | JKA | Substantially Equivalent | Becton Dickinson Infusion Therapy Systems, Inc. | accessdata.fda.gov |
| September 25, 2023 | K231888 | BD Texium Needle-Free Syringe | FMF | Substantially Equivalent | Care Fusion | accessdata.fda.gov |
| September 22, 2023 | K231239 | Nexiva Closed IV Catheter System with NearPort IV Access | FOZ | Substantially Equivalent | Becton Dickinson Infusion Therapy Systems, Inc. | accessdata.fda.gov |
| July 21, 2023 | K221327 | BD Alaris Pump Infusion Sets | FPA | Substantially Equivalent | Care Fusion | accessdata.fda.gov |
| April 7, 2023 | K223088 | BD SmartSite Needle-Free Connector | FPA | Substantially Equivalent | Care Fusion | accessdata.fda.gov |
| March 24, 2023 | K223076 | BD Texium Closed Male Luer | ONB | Substantially Equivalent | Care Fusion | accessdata.fda.gov |
| October 14, 2022 | K221504 | BD Surgiphor Antimicrobial Irrigation System | FQH | Substantially Equivalent | Bd | 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 |
| March 31, 2022 | K220584 | BD Cathena Safety IV Catheter | FOZ | Substantially Equivalent | Becton Dickinson Infusion Therapy Systems, Inc. | 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 |
| May 6, 2021 | K201936 | SmartSite Bag 500mL, SmartSite Bag 250 mL, SmartSite Bag 100 mL | KPE | Substantially Equivalent | Gilero, LLC | accessdata.fda.gov |
| February 23, 2021 | K200439 | Velano ExT Extension Set | FPA | Substantially Equivalent | Velano Vascular | accessdata.fda.gov |
| December 18, 2020 | K201075 | BD Insyte Autoguard Shielded IV Catheter, BD Insyte Autoguard BC Shielded IV Catheter, BD Insyte Autoguard BC Pro Shielded IV Catheter | FOZ | 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 |
| October 21, 2020 | K201155 | PleurX Peritoneal Catheter System | PNG | Unknown | Care Fusion | 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 22, 2020 | K201717 | BD Cathena Safety IV Catheter | FOZ | Substantially Equivalent | Becton Dickinson Infusion Therapy Systems, Inc. | 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 |
| January 21, 2020 | K193569 | PIVO(TM) | JKA | Substantially Equivalent | Velano Vascular | accessdata.fda.gov |
| May 13, 2019 | K190604 | PIVO | JKA | Substantially Equivalent | Velano Vascular | accessdata.fda.gov |
| April 30, 2019 | K182092 | BD Intelliport System | PHC | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| March 26, 2019 | K182897 | Velano Vascular Q2 Extension Set | FPA | Substantially Equivalent | Velano Vascular | accessdata.fda.gov |
| March 20, 2019 | K183399 | BD Nexiva Closed IV Catheter System | FOZ | Substantially Equivalent | Becton Dickinson Infusion Therapy Systems, Inc. | accessdata.fda.gov |
| November 30, 2018 | K181221 | BD PhaSeal Optima Closed System Transfer Device | ONB | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| December 15, 2017 | K173354 | BD Nexiva Diffusics Closed IV Catheter Systems | FOZ | Substantially Equivalent | Becton Dickinson Infusion Therapy Systems, Inc. | accessdata.fda.gov |
| November 2, 2017 | K170405 | BD Curve Ascites Shunt | KPM | Unknown | Care Fusion | accessdata.fda.gov |
| September 11, 2017 | K171531 | Jamshidi Bone Marrow Biopsy/Aspiration Needle, Jamshidi T-Handle Bone Marrow Biopsy/Aspiration Needle, Jamshidi Evolve Bone Marrow Biopsy/Aspiration Needle | KNW | Substantially Equivalent | Care Fusion | accessdata.fda.gov |
| September 1, 2017 | K171117 | Carefusion NeutraClear Needle-free connector (EL-NC1000) | FPA | Substantially Equivalent | Cair Lgl | accessdata.fda.gov |
| August 15, 2017 | K171118 | Carefusion NeutraClear multi-fuse Extension Set with needle-free connector(s) | FPA | Substantially Equivalent | Cair Lgl | accessdata.fda.gov |
| July 31, 2017 | K171132 | Carefusion NeutraClear Needle-free connector | FPA | Substantially Equivalent | Cair Lgl | accessdata.fda.gov |
| July 19, 2017 | K171957 | MaxZero Extension Sets with Needless Connector | FPA | Substantially Equivalent | Carefusion 303, Inc. | accessdata.fda.gov |
| February 27, 2017 | K163591 | BD PosiFlush Heparin Lock Flush Syringe | NZW | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| February 9, 2017 | K163508 | PIVO | JKA | Substantially Equivalent | Velano Vascular | 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 |
| October 31, 2016 | K160450 | Pleurx Pleural Catheter System | DWM | Substantially Equivalent | Care Fusion | 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 |
| January 7, 2016 | K152924 | TIVA¿ | JKA | Substantially Equivalent | Velano Vascular | accessdata.fda.gov |
| September 2, 2015 | K151766 | BD Single Use, Hypodermic Syringe | FMF | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| July 27, 2015 | K151698 | BD Angiocath IV Catheter, BD Insyte IV Catheter | FOZ | Substantially Equivalent | Becton Dickinson Infusion Therapy Systems, Inc. | accessdata.fda.gov |
| January 8, 2015 | K142946 | TIVA | JKA | Substantially Equivalent | Velano Vascular, Inc. | accessdata.fda.gov |
| November 20, 2014 | K143234 | MaxZero Administration Sets | FPA | Substantially Equivalent | Care Fusion | accessdata.fda.gov |
| September 19, 2014 | K142527 | Extension Set with BD Q-Syte Luer Access Split Septum | FPA | Substantially Equivalent | Acacia, Inc. | 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 |
| April 15, 2014 | K140831 | MAXZERO EXTENSION SET WITH NEEDLESS CONNECTOR | FPA | Substantially Equivalent | Care Fusion | accessdata.fda.gov |
| October 4, 2013 | K132863 | SMARTSITE VIALSHIELD | LHI | Substantially Equivalent | Yukon Medical, LLC | accessdata.fda.gov |
| August 29, 2013 | K132413 | MZ1000 | FPA | Substantially Equivalent | Care Fusion | 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 |
| August 14, 2012 | K122265 | VIALOK SINGLE VIAL ACCESS DEVICE VENTED | LHI | Substantially Equivalent | Yukon Medical, LLC | accessdata.fda.gov |
| May 3, 2012 | K121182 | VIALOK NON-VENTED | LHI | Substantially Equivalent | Yukon Medical, LLC | accessdata.fda.gov |
| March 19, 2012 | K113854 | PLEURX PERITONEAL CATHETER SYSTEM | PNG | Unknown | Care Fusion | accessdata.fda.gov |
| February 16, 2012 | K112831 | PLEURX PLEURAL CATHETER SYSTEMS | DWM | Substantially Equivalent | Care Fusion | accessdata.fda.gov |
| September 29, 2011 | K112434 | BD ORAL/ENTERAL SYRINGE WITH BD UNIVIA CONNECTION | KNT | Substantially Equivalent | Bd Medical Surgical | accessdata.fda.gov |
| May 13, 2011 | K110771 | BD SINGLE USE, HYPODERMIC SYRINGE | FMF | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| January 6, 2011 | K102520 | BD NEXIVA CLOSED IV CATHETER SYSTEM | FOZ | Substantially Equivalent | Becton Dickinson Infusion Therapy Systems, Inc. | accessdata.fda.gov |
| February 19, 2010 | K100209 | BD ECLIPSE NEEDLE WITH SMARTSLIP TECHNOLOGY | FMI | Substantially Equivalent | Becton, Dickinson & CO | accessdata.fda.gov |
| December 7, 2009 | K092782 | INJECTOR LUER, MODEL N34, INJECTOR LUER LOCK, MODEL N35, INJECTOR LUER LOCK, N35C, CONNECTOR LUER LOCK, MODEL C35, | LHI | Substantially Equivalent | Carmel Pharma Ab. | 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 23, 2009 | K090634 | PHASEAL PROTECTOR P14, P21, P28 AND P50 | LHI | Substantially Equivalent | Carmel Pharma Ab. | accessdata.fda.gov |
| December 9, 2008 | K083472 | MEDEGEN PRESSURE RATED EXTENSION SETS | FPA | Substantially Equivalent | Medegen, Inc. | accessdata.fda.gov |
| July 17, 2008 | K081446 | BD SPINAL NEEDLE, MODELS: 405081, 405235, 405236, 405237 | BSP | Substantially Equivalent | Becton, Dickinson & CO | accessdata.fda.gov |
| December 14, 2007 | K071400 | SMARTSITE STOPCOCK | FMG | Substantially Equivalent | Cardinal Health, Alaris Products | accessdata.fda.gov |
| September 25, 2007 | K072542 | MAXPLUS TRU-SWAB POSITIVE DISPLACEMENT CONNECTOR | FPA | Substantially Equivalent | Medegen Medical Manufacturing System | accessdata.fda.gov |
| May 24, 2007 | K071108 | TEXIUM SYRINGE | FMF | Substantially Equivalent | Cardinal Health, Alaris Products | accessdata.fda.gov |
| March 16, 2007 | K070440 | BD HYPOINT NEEDLE | FMI | Substantially Equivalent | Becton, Dickinson & CO | accessdata.fda.gov |
| July 26, 2006 | K061285 | SMARTSITE NEEDLE FREE VALVE ADMINISTRATION SETS | FPA | Substantially Equivalent | Cardinal Health, Alaris Products | accessdata.fda.gov |
| January 12, 2006 | K053049 | ALARIS SAFETY MALE LUER | FPA | Substantially Equivalent | Cardinal Health, Alaris Products | accessdata.fda.gov |
| August 16, 2005 | K051930 | DRUG ACCESS SPIKE | FMF | Substantially Equivalent | Medegen Medical Manufacturing Services | accessdata.fda.gov |
| June 22, 2005 | K051499 | INTRAVASCULAR ADMINISTRATION SET AND EXTENSION SET | FPA | Substantially Equivalent | Medegen Medical Manufacturing Services | accessdata.fda.gov |
| April 1, 2005 | K050115 | BLOOD HAND PUMP ADMINISTRATION SET | BRZ | Substantially Equivalent | Cardinal Health, Alaris Products | accessdata.fda.gov |
| December 29, 2004 | K043397 | MODIFICATION TO BD ECLIPSE HYPODERMIC NEEDLE | FMI | Substantially Equivalent | Becton, Dickinson & CO | accessdata.fda.gov |
| September 9, 2003 | K032528 | BD ECLIPSE BIFURCATED NEEDLE | SCL | Substantially Equivalent | Becton, Dickinson & CO | accessdata.fda.gov |
| May 8, 2003 | K030573 | BD VACUTAINER PUSH BUTTON BLOOD COLLECTION SET, MODELS 367338, 367344, 367336, 367342, 367335, 367341 | JKA | Substantially Equivalent | Bd Vacutainer Systems Preanalyical Solutions | accessdata.fda.gov |
| August 6, 2002 | K022209 | ALARIS MEDICAL INFUSION SYSTEM ADMINISTRATION SETS | FPA | Substantially Equivalent | Alaris Medical Systems, Inc. | accessdata.fda.gov |
| July 19, 2002 | K021475 | BD SINGLE LUMEN NEEDLE, SYRINGE AND BLOOD COLLECTION SET | FMI | Substantially Equivalent | Bd | accessdata.fda.gov |
| June 12, 2002 | K020834 | BD INTROSYTE PRECISION INTRODUCER; BD INTROSYTE-N PRECISION INTRODUCER; BD INTROSYTE AUTOGUARD SHIELDED INTRODUCER; BD I | DYB | Substantially Equivalent | Becton Dickinson Infusion Therapy Systems, Inc. | accessdata.fda.gov |
| April 16, 2002 | K013621 | BD SAF-T PRN LUER ACTIVATED VALVE, MODEL 385100 | FPA | Substantially Equivalent | Becton Dickinson Infusion Therapy Systems, Inc. | accessdata.fda.gov |
| March 20, 2002 | K020523 | BD BIFURCATED NEEDLE, MODELS 301754, 301755, 301756, 301757 | SCL | Substantially Equivalent | Bd | accessdata.fda.gov |
| December 21, 2001 | K013800 | INSYTE, ANGIOCATH, INSYTE AUTOGUARD, ANGIOCATH AUTOGUARD, AUTOGUARD PRO, INTIMA, AND SAF-T-INTIMA INTRAVASCULAR CATHETE | FOZ | Substantially Equivalent | Becton Dickinson Infusion Therapy Systems, 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 |
|---|---|---|---|---|---|---|
| July 13, 2023 | 92561 | Class II | Ongoing | Snowden-Pencer MIS DIAMOND-TOUCH GRASPER MCKERNAN FUNDUS 5MM, 32CM, RATCHETED, REF SP90-7012; endoscopic surgical device | Specific lots of the product have the potential to exhibit cracking or breaking of the rotation knob due to the incorrect use of an adhesive in the manufacturing process. | accessdata.fda.gov |
| March 16, 2023 | 91722 | Class II | Ongoing | (1) Carefusion V. Mueller Graves Vaginal Speculum, Catalog #GL11, Medium Blade, 4 x 1 3/8" (10.2 X 3.5cm); and (2) Carefusion V. Mueller Pederson Vaginal Specula, Catalog #GL31, Medium, 4 x 7/8" (10.2 x 2.2cm). | A portion of the two products were incorrectly marked (etched) and packaged resulting in a product mismatch. The labels and laser etchings were switched on the two products. | accessdata.fda.gov |
| January 30, 2023 | 91572 | Class II | Ongoing | CD5 Series of Genesis Reusable Rigid Sterilization Container Systems catalog number and product name: 1. CD5-3B, CONTAINER SHALLOW LG ENDO 3IN PERF; 2. CD5-3C, CONTAINER SHALLOW LG ENDO 3IN SOLID; 3. CD5-61B, GENESIS CON | Product did not meet shelf-life testing requirements resulting in a breach of the sterility of the Genesis container holding surgical equipment. | accessdata.fda.gov |
| November 2, 2022 | 90967 | Class II | Ongoing | CareFusion V. Mueller CUSHING BAYONET BIPOLAR INSULATED FORCEPS, 0.7MM TIP OVERALL LENGTH 7-1/2" (190MM), REF F-1000 | BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the device power supply, as well as cleaning and maintenance instructions. Refer to the attached V. Mueller" Bipolar Forcep IFU. | accessdata.fda.gov |
| September 26, 2022 | 90958 | Class II | Ongoing | CareFusion V.Mueller GENESIS MINI CONTAINER 10-1/2 X 7-1/2" (26.7X19.0CM) 3" (7.6CM) DEEP STERRAD COMPATIBLE, REF CD0-3ST | Genesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirements for aerosol challenge testing. | accessdata.fda.gov |
| February 23, 2022 | 89561 | Class II | Terminated | (a) CareFusion Snowden-Pencer Plastics, Endoplastic Endoscope 10 mm, 30 degrees 7", 17.5 cm, Catalog #88-5910; (b) CareFusion Snowden-Pencer Plastics, Endoplastic Endoscope 5 mm, 30 degrees 7", 17.5 cm, Catalog #88-5920; | The finished device package did not contain the IFU. | accessdata.fda.gov |
| May 28, 2020 | 85751 | Class II | Terminated | Thora-Para 5 Fr Non-Valved Catheter Drainage Tray | The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the introduction of up to 30cc of air into the patient. | accessdata.fda.gov |
| May 18, 2020 | 85747 | Class II | Terminated | Mueller Knife Handle, Hexagonal - Product Usage: Intended to hold surgical blades. | Becton Dickinson and Company, is conducting a voluntary recall on the V. MuellerTM 3H Knife Handles catalog number listed in the table above. BD has been informed by our supplier that the external threads on some of the collets (Figure 1) contain a machining burr, potentially causing the collet to not fully seat in the knife handle (Figure 2), inhibiting com | accessdata.fda.gov |
| February 23, 2017 | 76620 | Class II | Terminated | Manometer, 550 ml three-Way Stopcock; STERILE | The integrity of the sterile packaging is potentially compromised. | accessdata.fda.gov |
| September 23, 2016 | 75297 | Class II | Terminated | V. Mueller Neuro/Spine, SHADOW-LINE, SPINAL DISTRACTION SCREW, STERILE, various sizes (12mm, 14mm, 16mm and 18mm) 5 PER BOX. | Potential risk associated with corrosion demonstrated on the distraction screw surface. | accessdata.fda.gov |
| July 1, 2016 | 74465 | Class I | Terminated | DIAMOND-FLEX CIRCULAR RETRACTOR, ANGLED, 40MM 5MM, Product Code 89-6114, Lot Code(s): 878971; 879366; 879404, and Date Code: C16. Designed to retract or elevate organs and tissue to provide better visualization access. | BD, formerly CareFusion, has identified a potential risk associated with a weld failure which could result in the wire protruding thru the tip of the instrument when articulated. If this failure were to occur while in use in a procedure it has the potential to damages tissue or organs | accessdata.fda.gov |
| June 29, 2016 | 74647 | Class II | Terminated | Broselow/Hinkle, PEDIATRIC EMERGENCY SYSTEM, PINK/RED Oxygen Delivery Module 2/PACK, Product Code 7700RAW2 | The Oral Airway pouch within the PINK/RED Oxygen Delivery Module, 7700RAW, was incorrectly packaged with the 8 cm Berman Oral Airway. The pouch contained within the module is correctly labeled as 5 cm but actually contains an 8 cm Berman Oral Airway component. Therefore, the component within the pouch is incorrect. The PINK/RED Oxygen Delivery Module, 7700RA | accessdata.fda.gov |
| July 31, 2014 | 68955 | Class II | Terminated | CareFusion AirLife Heated Infant Breathing Circuit Product Usage: Respiratory breathing circuits are used with a ventilator when mechanical ventilation is administered to a patient. | The CareFusion AirLife Heated Infant Breathing Circuit is being recalled due to a regulatory compliance risk involving a material change. The changes to the gas pathway may potentially impact the safety of the device and quality of the gas condensates to the patient. | accessdata.fda.gov |
| August 28, 2013 | 66123 | Class II | Terminated | 1) Cat. 4341B; Qty. 10; Thoracentesis Tray; With Catheter; Sterile; CareFusion; 1500 Waukegan Road; McGaw Park, IL 60085 USA; *** 2) Cat. 4341BSDF; Qty. 10; Safe-T Thoracentesis Tray; With Catheter and Sharps Injury Prot | Catheters included in Thoracentesis Tray and Safe-T Thoracentesis Tray - Drug Free may occlude, preventing drainage of excessive fluid from the pleural cavity leading to a potential delay in the medical procedure and potentially serious patient complications. | accessdata.fda.gov |
| April 22, 2013 | 64971 | Class II | Terminated | 1) Adult Manual Resuscitator, 2K8004, Oxygen Reservoir Bag, Adult Mask; 2) Adult Manual Resuscitator, 2K8005, 40" (1.0 m) Oxygen Reservoir Tubing, Adult Mask; 3) Adult Manual Resuscitator, 2K8017, Variable Volume Oxygen | CareFusion has received four (4) customer reports of a component (oxygen connector) within the resuscitation bag being occluded which disables the flow of supplemental oxygen to the resuscitation bag and thus may pose a serious patient safety risk. | accessdata.fda.gov |
| May 29, 2012 | 61943 | Class I | Terminated | AirLife Isothermal Breathing Circuit, Infant Respiratory Circuit, Heated; an Rx device for single patient use; CareFusion, 22745 Savi Ranch Parkway, Yorba Linda, CA 92887 USA, Made in Mexico Respiratory breathing circuit | The Y adapter within the breathing circuit may spontaneously crack, causing a leak in the closed ventilation system. This leak could lead to a decrease in the tidal volume delivered to the ventilated patient. | accessdata.fda.gov |
| February 7, 2012 | 61103 | Not yet classified | Terminated | Wet PVP-I Small Procedure Preoperative Skin Prep Tray containing 1 - 59 mL bottle Povidone Iodine Cleansing Solution (Scrub) USP 7.5% and 1 - 59 mL bottle Povidone Iodine Topical Solution (Paint) USP 10% with Powder-Free | The povidone-iodine (PVP-I) solution bottles in the trays may have loose caps, allowing leakage and also elevated levels of ethylene oxide (EO) sterilant and/or by-products within the PVP-I solution, which may represent a patient safety hazard. | accessdata.fda.gov |
| June 25, 2010 | 56085 | Not yet classified | Terminated | Temno Coaxial Chiba Fine Needle Aspiration; a coaxial introducer needle (20G x 15 cm) with a Chiba biopsy needle (22G x 20 cm); sterile, for single use only sets, 5 sets per case; CareFusion, McGaw Park, IL 60085 USA, Ma | The introducer needle is only 10 cm in length instead of the required 15 cm. | accessdata.fda.gov |
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Updated February 25, 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.