Browse Device Recalls
35,307 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 35,307 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 35,307 FDA device recalls, Class II.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Nov 9, 2022 | BIOBALL P.AERUGINOSA NCTC 12924 550X20, CATALOG 56017 | As the temperature and time out of range was exceeded, product performances cannot be guaranteed | Class II | Biomerieux Inc |
| Nov 9, 2022 | ETEST CLINICAL FLUCONAZOLE FL 256 US S30, CATALOG 412333 | As the temperature and time out of range was exceeded, product performances cannot be guaranteed | Class II | Biomerieux Inc |
| Nov 9, 2022 | ETEST CLINICAL ERYTHROMYCIN EM 256 US S30, CATALOG 412333 | As the temperature and time out of range was exceeded, product performances cannot be guaranteed | Class II | Biomerieux Inc |
| Nov 9, 2022 | ETEST CLINICAL LEVOFLOXACIN LE 32 US S30, CATALOG 412392 | As the temperature and time out of range was exceeded, product performances cannot be guaranteed | Class II | Biomerieux Inc |
| Nov 9, 2022 | VITEK MS CLINICAL REAGENT VITEK MS-FA, CATALOG 411072 | As the temperature and time out of range was exceeded, product performances cannot be guaranteed | Class II | Biomerieux Inc |
| Nov 9, 2022 | PREVI COLOR GRAM REAGENT IODINE-B (NA), CATALOG 29586 | As the temperature and time out of range was exceeded, product performances cannot be guaranteed | Class II | Biomerieux Inc |
| Nov 9, 2022 | VITEK 2 REAGENT AST-GN95 TEST KIT 20 CARDS, CATALOG 421982 | As the temperature and time out of range was exceeded, product performances cannot be guaranteed | Class II | Biomerieux Inc |
| Nov 9, 2022 | VITEK 2 REAGENT YST TEST KIT VTK2 20 CARDS, CATALOG 21343 | As the temperature and time out of range was exceeded, product performances cannot be guaranteed | Class II | Biomerieux Inc |
| Nov 9, 2022 | VITEK 2 REAGENT GP TEST KIT VTK2 20 CARDS, CATALOG 21342 | As the temperature and time out of range was exceeded, product performances cannot be guaranteed | Class II | Biomerieux Inc |
| Nov 9, 2022 | ETEST CLINICAL AMOXI/CLAV 2/1 XL 256 US S30, CATALOG 412252 | As the temperature and time out of range was exceeded, product performances cannot be guaranteed | Class II | Biomerieux Inc |
| Nov 9, 2022 | VIDAS CLINICAL VIDAS MEASLES IGG 60TESTS, CATALOG 30219 | As the temperature and time out of range was exceeded, product performances cannot be guaranteed | Class II | Biomerieux Inc |
| Nov 9, 2022 | VIDAS CLINICALVIDAS VARICEL. ZOSTER IGG 60 T, CATALOG 30217 | As the temperature and time out of range was exceeded, product performances cannot be guaranteed | Class II | Biomerieux Inc |
| Nov 9, 2022 | VIDAS CLINICAL VIDAS BRAHMS PROCALCITONIN 60T, CATALOG 30450-01 | As the temperature and time out of range was exceeded, product performances cannot be guaranteed | Class II | Biomerieux Inc |
| Nov 9, 2022 | ASTUTE REAGENT ASTUTE ELECTRONIC QUALITY CTRL DEVICE US, CATALOG 400016 | As the temperature and time out of range was exceeded, product performances cannot be guaranteed | Class II | Biomerieux Inc |
| Nov 9, 2022 | ETEST CLINICAL CEFTOLOZANE/TAZO C/T US S30, CATALOG 414445 | As the temperature and time out of range was exceeded, product performances cannot be guaranteed | Class II | Biomerieux Inc |
| Nov 9, 2022 | VITEK 2 REAGENT AST-GN73 TEST KIT 20 CARDS, CATALOG 413404 | As the temperature and time out of range was exceeded, product performances cannot be guaranteed | Class II | Biomerieux Inc |
| Nov 9, 2022 | DCOUNT SYSTEMS REAGENTS CHEMCHROME V14 (6X1.8ML), CATALOG 306-R1026-01 | As the temperature and time out of range was exceeded, product performances cannot be guaranteed | Class II | Biomerieux Inc |
| Nov 9, 2022 | API 20 E 25 STRIPS, CATALOG 20100 | As the temperature and time out of range was exceeded, product performances cannot be guaranteed | Class II | Biomerieux Inc |
| Nov 9, 2022 | VIDAS CLINICAL VIDAS PROGESTERONE 60 TESTS, CATALOG 30409-01 | As the temperature and time out of range was exceeded, product performances cannot be guaranteed | Class II | Biomerieux Inc |
| Nov 9, 2022 | API STAPH 25 STRIPS+25 MEDIA, CATALOG 20500 | As the temperature and time out of range was exceeded, product performances cannot be guaranteed | Class II | Biomerieux Inc |
| Nov 9, 2022 | PPM LOMBARD PRODUCTS IRR COUNT-TACT 3P AGAR 100 PLT, CATALOG 418049 | As the temperature and time out of range was exceeded, product performances cannot be guaranteed | Class II | Biomerieux Inc |
| Nov 9, 2022 | ETEST CLINICAL ETEST MEROPENEM MP M100 US, CATALOG 423786 | As the temperature and time out of range was exceeded, product performances cannot be guaranteed | Class II | Biomerieux Inc |
| Nov 9, 2022 | PPM CLINICAL CHROMID MRSA 20 PLT US, CATALOG 43841 | As the temperature and time out of range was exceeded, product performances cannot be guaranteed | Class II | Biomerieux Inc |
| Nov 9, 2022 | ETEST CLINICAL CEFTAZIDIM/AVIBACTAM US S30, CATALOG 419046 | As the temperature and time out of range was exceeded, product performances cannot be guaranteed | Class II | Biomerieux Inc |
| Nov 9, 2022 | VITEK 2 REAGENT AST-GN79 TEST KIT 20 CARDS, CATALOG 413436 | As the temperature and time out of range was exceeded, product performances cannot be guaranteed | Class II | Biomerieux Inc |
| Nov 9, 2022 | ETEST CLINICAL MINOCYCLINE MC 256 US S30, CATALOG 412407 | As the temperature and time out of range was exceeded, product performances cannot be guaranteed | Class II | Biomerieux Inc |
| Nov 9, 2022 | VIDAS CLINICAL VIDAS SALMONELLA 60T, CATALOG 30702 | As the temperature and time out of range was exceeded, product performances cannot be guaranteed | Class II | Biomerieux Inc |
| Nov 9, 2022 | PPM LOMBARD PRODUCTS TSA 3P W NEUTRALIZERS 100 PLT, CATALOG 423723 | As the temperature and time out of range was exceeded, product performances cannot be guaranteed | Class II | Biomerieux Inc |
| Nov 9, 2022 | TEMPO REAGENTS TEMPO CONTROL KIT , CATALOG 80000 | As the temperature and time out of range was exceeded, product performances cannot be guaranteed | Class II | Biomerieux Inc |
| Nov 9, 2022 | API 20 C AUX 25 STRIPS+25 MEDIA, CATALOG 20210 | As the temperature and time out of range was exceeded, product performances cannot be guaranteed | Class II | Biomerieux Inc |
| Nov 9, 2022 | VITEK 2 REAGENT AST-GN81 TEST KIT 20 CARDS, CATALOG 413438 | As the temperature and time out of range was exceeded, product performances cannot be guaranteed | Class II | Biomerieux Inc |
| Nov 9, 2022 | VITEK 2 REAGENT AST-GP75 TEST KIT 20 CARDS, CATALOG 415670 | As the temperature and time out of range was exceeded, product performances cannot be guaranteed | Class II | Biomerieux Inc |
| Nov 9, 2022 | PPM LOMBARD PRODUCTS TSA 3P W NEUTRALIZERS 100 PLT, CATALOG 419014 | As the temperature and time out of range was exceeded, product performances cannot be guaranteed | Class II | Biomerieux Inc |
| Nov 9, 2022 | PPM CLINICAL CRAPONNE CLINICAL CHROMID CANDIDA 20 PLATES, CATALOG 43631 | As the temperature and time out of range was exceeded, product performances cannot be guaranteed | Class II | Biomerieux Inc |
| Nov 9, 2022 | PPM LOMBARD PRODUCTS CT&TI-TSA + L & P80 10PLT, CATALOG C6045-TI | As the temperature and time out of range was exceeded, product performances cannot be guaranteed | Class II | Biomerieux Inc |
| Nov 9, 2022 | GENE-UP REAGENT GENE-UP Salmonella 2, CATALOG 423105 | As the temperature and time out of range was exceeded, product performances cannot be guaranteed | Class II | Biomerieux Inc |
| Nov 9, 2022 | ETEST CLINICAL CEFTRIAXONE TX 32 US S30, CATALOG 412302 | As the temperature and time out of range was exceeded, product performances cannot be guaranteed | Class II | Biomerieux Inc |
| Nov 9, 2022 | PPM LOMBARD PRODUCTS R2A MEDIUM 10PLT, CATALOG M1065 | As the temperature and time out of range was exceeded, product performances cannot be guaranteed | Class II | Biomerieux Inc |
| Nov 9, 2022 | VIDAS CLINICAL QCV-QUALITY CONTROL VIDAS 60T, CATALOG 30706 | As the temperature and time out of range was exceeded, product performances cannot be guaranteed | Class II | Biomerieux Inc |
| Nov 9, 2022 | PPM INDUSTRY COMBOURG LPT BROTH (4X3L), CATALOG 410849 | As the temperature and time out of range was exceeded, product performances cannot be guaranteed | Class II | Biomerieux Inc |
| Nov 9, 2022 | PPM CLINICAL CHROMID MRSA S AUREUS 20PLT US, CATALOG 414524 | As the temperature and time out of range was exceeded, product performances cannot be guaranteed | Class II | Biomerieux Inc |
| Nov 9, 2022 | GENE-UP REAGENT GENE-UP LYSIS KIT, CATALOG 414057 | As the temperature and time out of range was exceeded, product performances cannot be guaranteed | Class II | Biomerieux Inc |
| Nov 9, 2022 | ETEST CLINICAL ETEST VANCOMYCIN VA M100 US, CATALOG 423788 | As the temperature and time out of range was exceeded, product performances cannot be guaranteed | Class II | Biomerieux Inc |
| Nov 9, 2022 | ETEST CLINICAL IMIPENEM IP 32 US S30, CATALOG 412373 | As the temperature and time out of range was exceeded, product performances cannot be guaranteed | Class II | Biomerieux Inc |
| Nov 9, 2022 | PREVI COLOR GRAM REAGENT NOZZLE CLEANING SOLUTION (NA), CATALOG 29588 | As the temperature and time out of range was exceeded, product performances cannot be guaranteed | Class II | Biomerieux Inc |
| Nov 9, 2022 | VITEK 2 REAGENT AST-ST02 TEST KIT 20 CARDS, CATALOG 420915 | As the temperature and time out of range was exceeded, product performances cannot be guaranteed | Class II | Biomerieux Inc |
| Nov 9, 2022 | VITEK 2 REAGENT AST-GN99 TEST KIT 20 CARDS, CATALOG 423102 | As the temperature and time out of range was exceeded, product performances cannot be guaranteed | Class II | Biomerieux Inc |
| Nov 9, 2022 | API NIT1 NIT2 REAGENTS, CATALOG 70442 | As the temperature and time out of range was exceeded, product performances cannot be guaranteed | Class II | Biomerieux Inc |
| Nov 9, 2022 | BIOBALL A.BRASILIENSIS NCPF 2275 550X20, CATALOG 56011 | As the temperature and time out of range was exceeded, product performances cannot be guaranteed | Class II | Biomerieux Inc |
| Nov 9, 2022 | ETEST CLINICAL TOBRAMYCIN TM 256 US S30, CATALOG 412478 | As the temperature and time out of range was exceeded, product performances cannot be guaranteed | Class II | Biomerieux 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.