Browse Device Recalls
368 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 368 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 368 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jan 5, 2026 | VITEK 2 Gram-negative Susceptibility Cards Containing o Polymyxin B (pb02n) ... | Potential risk of Quality Control failures and/or false resistant antibiotic results when testing... | Class II | Biomerieux Inc |
| Mar 14, 2024 | VITEK 2 - AST Test kits (in vitro diagnostic test cards for antimicrobial sus... | Ceftriaxone (cro02n) concentration errors associated with specific recently manufactured test kit... | Class I | Biomerieux Inc |
| Feb 6, 2023 | MYLA comprises AST Filters in conjunction with VITEK MS; middleware which con... | For users with MYLA V4.8.X / V4.9 that use VITEK MS to identify organisms as part of their workfl... | 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 | 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 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 | 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 | 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 | 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 | 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 | 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 | 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 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 | 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 | 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 | 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 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 | 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 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 | 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 | 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 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 | 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 ERTAPENEM ETP 32 US S30, CATALOG 412331 | 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 IR&DB - TSA (32ML) 10PLT, CATALOG M1205-IR | 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&IR&DB-TSA + L & P80 10PLT, CATALOG C6045-IR | As the temperature and time out of range was exceeded, product performances cannot be guaranteed | Class II | Biomerieux Inc |
| Nov 9, 2022 | ASTUTE REAGENT NEPHROCHECK LIQUID CONTROLS KIT US, CATALOG 500013 | 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 GN TEST KIT VTK2 20 CARDS, CATALOG 21341 | As the temperature and time out of range was exceeded, product performances cannot be guaranteed | Class II | Biomerieux Inc |
| Nov 9, 2022 | ETEST CLINICAL BENZYLPENICIL PG 256 US S30, CATALOG 412262 | 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 LH 60 TESTS, CATALOG 30406-01 | 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-GN69 TEST KIT 20 CARDS, CATALOG 413400 | 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 412240 | As the temperature and time out of range was exceeded, product performances cannot be guaranteed | Class II | Biomerieux Inc |
| Nov 9, 2022 | API JAMES 2AMP, CATALOG 70542 | 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 T PHOSPHATE BUFFERSTERILE 20X9ML, CATALOG T8035 | As the temperature and time out of range was exceeded, product performances cannot be guaranteed | Class II | Biomerieux Inc |
| Nov 9, 2022 | API VP1 VP2 REAGENTS, CATALOG 70422 | 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 BACARA 20PLATES 90MM, CATALOG AEB520100 | 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 ESTRADIOL II 60 TESTS, CATALOG 30431-01 | 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 RELEBACTAM IPR US S30, CATALOG 420927 | 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-GP67 TEST KIT 20 CARDS, CATALOG 22226 | 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 | PPM CLINICAL CRAPONNE CHROMID C.DIFFICILE 20 PLT, CATALOG 43871 | 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-CHCA, CATALOG 411071 | 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 BCL TEST KIT VTK2 20 CARDS, CATALOG 21345 | As the temperature and time out of range was exceeded, product performances cannot be guaranteed | Class II | Biomerieux Inc |
| Nov 9, 2022 | ETEST CLINICAL VANCOMYCIN VA 256 US S30, CATALOG 412486 | 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-GN70 TEST KIT 20 CARDS, CATALOG 413401 | As the temperature and time out of range was exceeded, product performances cannot be guaranteed | Class II | Biomerieux Inc |
| Nov 9, 2022 | BIOBALL K.RHIZOPHILA (30X20), CATALOG 412690 | 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 STREPTO B US 20 PLT, CATALOG 419751 | 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-XN15 TEST KIT 20 CARDS, CATALOG 423829 | 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 |
| 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 |
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.