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Browse Device Recalls

183 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 183 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Medical Device Recalls

Browse 183 FDA device recalls.

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DateProductReasonClassFirm
Sep 9, 2013 BBL (tm) MGIT (tm) Mycobacteria Growth Indicator Tube, part # 245122, package... An in-vitro diagnostic reagent may be labeled with an incorrect barcode, which when scanned on as... Class II Becton Dickinson & Co.
Jul 8, 2013 PrepStain AG. For use in the screening and detection of cervical cancer. PrepStain system rack setting was incorrectly entered on one PrepStain system during a routine pr... Class II Becton Dickinson & Co.
Jul 8, 2013 PrepStain Tecan US-II. For use in the screening and detection of cervical ... PrepStain system rack setting was incorrectly entered on one PrepStain system during a routine pr... Class II Becton Dickinson & Co.
Jul 8, 2013 PrepStain Tecan US-I. For use in the screening and detection of cervical c... PrepStain system rack setting was incorrectly entered on one PrepStain system during a routine pr... Class II Becton Dickinson & Co.
Jun 13, 2013 BD Affirm VPIII Microbial Identification Tests, packaged in kits, 120 test\ki... In vitro diagnostic test kit may exhibit invalid internal negative control results. Class II Becton Dickinson & Co.
Jun 6, 2013 BD BBL CDC Anaerobe 5% Sheep Blood Agar with Kanamycin and Vancomycin (KV), p... Microbiological identification media may exhibit reduced levels of Vancomycin. Class II Becton Dickinson & Co.
Jun 6, 2013 BBL Campylobacter CSM Agar (Charcoal-Based Selective Medium), Catalog # 29961... Microbiological identification media may exhibit reduced levels of Vancomycin. Class II Becton Dickinson & Co.
Jun 6, 2013 BBL Brucella Laked Blood Agar with Kanamycin and Vancomycin (KV), Catalog # 2... Microbiological identification media may exhibit reduced levels of Vancomycin. Class II Becton Dickinson & Co.
Jun 6, 2013 BD BBL BCYE Selective Agar with PAV, Catalog # 297880, packaged in cartons of... Microbiological identification media may exhibit reduced levels of Vancomycin. Class II Becton Dickinson & Co.
Jun 6, 2013 BD BBL Anaerobe CNA Agar with 5% Sheep Blood // Anaerobe Laked Sheep Blood KV... Microbiological identification media may exhibit reduced levels of Vancomycin. Class II Becton Dickinson & Co.
Jun 6, 2013 BD BBL BBE // CDC Anaerobe Laked Sheep Blood Agar with KV, packaged in carton... Microbiological identification media may exhibit reduced levels of Vancomycin. Class II Becton Dickinson & Co.
Jun 6, 2013 BD BBL Schaedler K-V Agar with 5% Sheep Blood, carton of 20 plates, catalog #... Microbiological identification media may exhibit reduced levels of Vancomycin. Class II Becton Dickinson & Co.
Jun 6, 2013 BD BBL Vancomycin Screen Agar, carton of 10 plates, catalog # 222204, labeled... Microbiological identification media may exhibit reduced levels of Vancomycin. Class II Becton Dickinson & Co.
May 31, 2013 BD MAX Instrument, catalog #441916 Product Usage: The BD MAX System, use... Electrical power module installed on some in vitro diagnostic instruments does not meet industry ... Class III Becton Dickinson & Co.
Apr 12, 2013 BBL DrySlide Oxidase Kit, catalog number 231746 Product Usage: Presumptiv... In-vitro diagnostic agents were placed into incorrect packaging for distribution to microbiologic... Class II Becton Dickinson & Co.
Apr 12, 2013 BBL DrySlide PYR Kit, catalog number 231747 Product Usage: Presumptive di... In-vitro diagnostic agents were placed into incorrect packaging for distribution to microbiologic... Class II Becton Dickinson & Co.
Mar 11, 2013 BBL(tm) Trypticase (tm) Soy Agar with 5% Sheep Blood. Used for culturing m... Microbiological media may be contaminated with bacteria. Class II Becton Dickinson & Co.
Mar 11, 2013 BBL(tm) CDC Anaerobe 5% Sheep Blood Agar. Used for culturing microorganisms. Microbiological media may be contaminated with bacteria. Class II Becton Dickinson & Co.
Mar 11, 2013 BBL(tm) Trypticase (tm) Soy Agar with 5% Sheep Blood and MacConkey II-I Plate... Microbiological media may be contaminated with bacteria. Class II Becton Dickinson & Co.
Feb 8, 2013 BD ProbeTec Neisseria gonorrhoeae (GC) Qx Amplified DNA Assay Reagent Pack, R... Increased levels of false positives in BD Probe Tech Neisseria gonorrhoeae Q Amplified DNA assay ... Class II Becton Dickinson & Co.
Dec 13, 2012 Becton, Dickinson and Company, BBL Crystal Enteric/Nonfermenter ID Kit, Catal... In-vitro diagnostic reagents for microbiological testing may be reversed in well positions in the... Class II Becton Dickinson & Co.
Dec 11, 2012 BD MAX PCR Cartridges Catalog #437519, box of 24 cartridges labeled in part:*... Cartridges are not sealing properly during PCR testing and may cause false results, indeterminate... Class II Becton Dickinson & Co.
Dec 10, 2012 BBL(TM) Fildes Enrichment, catalog number 211866, 10 tubes/pack, labeled in p... Enrichment media intended to enhance the cultivation of various microorganisms may fail to suppo... Class II Becton Dickinson & Co.
Nov 6, 2012 BD Phoenix PMIC-108 Panels, Catalog number 448418, labeled in part ***Becton,... An antibiotic susceptibility test kit may produce false intermediate or false resistant results w... Class II Becton Dickinson & Co.
Oct 22, 2012 BD BBL Taxo XV Factor Strips, Catalog number 231104, in shelf pack vials, fif... In vitro diagnostic test kit was not manufactured according to specifications and may cause false... Class II Becton Dickinson & Co.
Sep 18, 2012 Becton, Dickinson and Company, BD MAX (tm) (6 channel) Instruments, Catalog ... Clinical diagnostic instrument may exhibit minor defects, which could lead to erroneous test resu... Class II Becton Dickinson & Co.
May 22, 2012 BD GeneOhm Cdiff Assay , Catalog # 441401, 200 box tests 2-3 labeled in pa... Leakage in Cepheid SmartCycler reaction tubes. Class II Becton Dickinson & Co.
May 22, 2012 BD GeneOhm Cdiff Assay , Catalog #441400 200, box tests 1-3 labeled in part**... Leakage in Cepheid SmartCycler reaction tubes. Class II Becton Dickinson & Co.
May 22, 2012 BD GeneOhm MRSA ACP Assay, Catalog #441639, box 200 tests labeled in part***G... Leakage in Cepheid SmartCycler reaction tubes. Class II Becton Dickinson & Co.
May 22, 2012 BD GeneOhm VanR Assay , Catalog # 441250, 5 box tests labeled in part***Gene... Leakage in Cepheid SmartCycler reaction tubes. Class II Becton Dickinson & Co.
May 22, 2012 BD GeneOhm MRSA ACP Assay Catalog #441637, box 48 tests labeled in part***Gen... Leakage in Cepheid SmartCycler reaction tubes. Class II Becton Dickinson & Co.
Apr 12, 2012 Gram Crystal Violet 250 mL, catalog #212525, in cartons of 4 bottles. Gra... Potential for increase level of artifacts to appear as large, spherical and easy to distinguish o... Class II Becton Dickinson & Co.
Apr 12, 2012 BD Gram Stain Kit, containing 1- 250 mL bottle of Gram Crystal Violet, and a... Potential for increase level of artifacts to appear as large, spherical and easy to distinguish o... Class II Becton Dickinson & Co.

Frequently Asked Questions

When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.

All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.

Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.