Browse Device Recalls
71 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 71 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 71 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jun 11, 2014 | Thermo Scientific VersaTREK REDOX 1, Ref 7102-44, 80ml with Stir Bar (O2 aero... | Bottles did not provide positive signals within the time frame of the quality control specificati... | Class II | Remel Inc |
| Mar 17, 2014 | Oxoid Legionella Pneumo Groups 2-14, DR0802M, containing 50 tests per box. T... | A reagent contained within the product may return false negative results. | Class II | Remel Inc |
| Mar 17, 2014 | Oxoid Legionella Latex Test, DR0800M, containing 50 tests per box. The box c... | A reagent contained within the product may return false negative results. | Class II | Remel Inc |
| Feb 18, 2014 | Oxoid Vancomycin 30 mcg, each cartridge contains 50 susceptibility discs, CT0... | Some of the discs may not be impregnated with the antibiotic. | Class II | Remel Inc |
| Jan 24, 2014 | Oxoid Legionella BCYE Growth Supplement, For 500 ml of medium, SR0110C, packa... | The product may contain high levels of microbial contamination | Class II | Remel Inc |
| Nov 21, 2013 | Oxoid Antimicrobial Susceptibility Testing Disc, MEM10, REF: CT0774B, 10 mcg ... | Individual discs in the lot may not be sufficiently impregnated with antibiotic, resulting in sma... | Class II | Remel Inc |
| May 2, 2013 | Streptex* kit, Ref R30950501 ZL50, Rapid latex test for Streptococcal groupin... | The product may give weak or false negative test results. | Class II | Remel Inc |
| May 2, 2013 | Streptex* Latex D, Ref R30950901 ZL54, IVD, Latex reagent for streptococcal g... | The product may give weak or false negative test results. | Class II | Remel Inc |
| Apr 9, 2013 | Oxoid Antimicrobial Susceptibility Test Discs, Cefpodoxime 10 mcg., CT1612B, ... | Cartridges may contain individual discs which were not impregnated with antibiotic. | Class II | Remel Inc |
| Apr 9, 2013 | Oxoid Antimicrobial Susceptibility Test Discs, Ertapenem 10 mcg., CT1761B, pa... | Cartridges may contain individual discs which were not impregnated with antibiotic. | Class II | Remel Inc |
| Apr 9, 2013 | Oxoid Antimicrobial Susceptibility Test Discs, Norfloxacin 10 mcg., CT0434B, ... | Cartridges may contain individual discs which were not impregnated with antibiotic. | Class II | Remel Inc |
| Apr 9, 2013 | Oxoid Antimicrobial Susceptibility Test Discs, Ampicillin 10 mcg., CT0003B, p... | Cartridges may contain individual discs which were not impregnated with antibiotic. | Class II | Remel Inc |
| Apr 4, 2013 | remel RapID Yeast Plus System, 20 tests, Ref: R8311007, IVD, containing a 15-... | The two reagents supplied in the RapID Yeast Plus System kit (Reagent A and Reagent B) are mislab... | Class II | Remel Inc |
| Mar 25, 2013 | Oxoid Antimicrobial Susceptibility Test Discs F300 (Nitrofurantoin), Cat. #CT... | Use of affected lots may give false indication of susceptibility to Nitrofurantoin. | Class III | Remel Inc |
| Feb 19, 2013 | Remel X/pect Flu A&B Control Swabs, For In Vitro Diagnostic Use, Ref R246003... | Flu A+ Control Swabs incorrectly give Flu A- results when used for quality control testing with t... | Class III | Remel Inc |
| Nov 21, 2012 | Oxoid Antimicrobial Susceptibility Test Discs, CTO425B Ciprofloxacin CIP 5 mc... | Boxes labeled as CIP5 may contain cartridges of AMP5. | Class III | Remel Inc |
| Oct 10, 2012 | The product is a lyophilized growth supplement for use with dehydrated cultur... | The product may contain low level microbial contamination which could result in incorrect results. | Class II | Remel Inc |
| Aug 21, 2012 | Oxoid Antimicrobial Susceptibility Discs, Cefoxitin 30ug REF CT0119B, package... | The firm is recalling the product because the cartridges may contain discs that have an insuffici... | Class II | Remel Inc |
| Aug 21, 2012 | Oxoid Antimicrobial Susceptibility Test Discs, Aztreonam 30 ug, IVD, REF CT0... | The firm is recalling the product due to some cartridges may contain individual discs that are no... | Class II | Remel Inc |
| Aug 20, 2012 | Remel Xpect Clostridium difficile Toxin A/B, IVD, 20 clostridium difficile t... | The firm is recalling the products due to a potential for false negative test results. | Class II | Remel Inc |
| Aug 20, 2012 | Remel Xpect Clostridium difficile Toxin A/B, IVD, 40 clostridium difficile t... | The firm is recalling the products due to a potential for false negative test results. | Class II | Remel Inc |
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.