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 15, 2022 | ConvaTec AQUACEL Foam Ag Adhesive, wound dressing advesive | ConvaTec are voluntarily recalling a batch of AQUACEL¿ Foam Ag Adhesive 10cm x 10cm (x 10 pack) d... | Class II | ConvaTec, Inc |
| Nov 14, 2022 | iTotal Identity Impactor Handle, Model No. 1080-212/ED-07827 REV AE | Loctite thread locker (epoxy) may not have been applied to the screw that is part of the handle. ... | Class II | Conformis, Inc. |
| Nov 14, 2022 | Omnipod 5 Automated Insulin Delivery System Product catalog numbers: PT-000... | The firm has become aware of an issue with the Omnipod 5 Controller where the Controller charging... | Class II | Insulet Corporation |
| Nov 11, 2022 | Power-PRO 2, Model No. 6507, Item No. 650705550001 (US); 650700000000 (Intern... | Cot may experience unintended motion due to damaged cables. Potential risk of soft tissue injury ... | Class II | Stryker Medical Division of Stryker Corporation |
| Nov 11, 2022 | Abbott Alinity m System, REF 08N53-002, containing Amplification Detetction U... | The instrument was found to be installed without plunger assemblies in the clamp bar for an Ampli... | Class II | Abbott Molecular, Inc. |
| Nov 10, 2022 | Vivid S5 N ultrasound. Not marketed in the US. Used in ultrasound imaging... | Potential for batteries that have not been replaced at 2 years, as recommended in the Service Man... | Class II | GE Medical Systems, LLC |
| Nov 10, 2022 | Vivid S5 Ultrasound. Used in ultrasound imaging and analysis in Fetal/Ob... | Potential for batteries that have not been replaced at 2 years, as recommended in the Service Man... | Class II | GE Medical Systems, LLC |
| Nov 10, 2022 | Vivid i ultrasound. Marketed under the following 510(k) numbers: K033139, K0... | Potential for batteries that have not been replaced at 2 years, as recommended in the Service Man... | Class II | GE Medical Systems, LLC |
| Nov 10, 2022 | Vivid q ultrasound. Used in ultrasound imaging and analysis in Fetal/Obs... | Potential for batteries that have not been replaced at 2 years, as recommended in the Service Man... | Class II | GE Medical Systems, LLC |
| Nov 10, 2022 | Vivid q N ultrasound. Not marketed in the US. Used in ultrasound imagin... | Potential for batteries that have not been replaced at 2 years, as recommended in the Service Man... | Class II | GE Medical Systems, LLC |
| Nov 10, 2022 | X-CORE 2 Ti Core, Static. Part of the NuVasive X-Core Expandable VBR System ... | Potential that insert will be unable to disengage from the vertebral body replacement device/implant | Class II | NuVasive Inc |
| Nov 10, 2022 | Vivid S6 N ultrasound. Not marketed in the US. Used in ultrasound imaging... | Potential for batteries that have not been replaced at 2 years, as recommended in the Service Man... | Class II | GE Medical Systems, LLC |
| Nov 10, 2022 | Vivid i N ultrasound. Not marketed in the US. Used in ultrasound imaging ... | Potential for batteries that have not been replaced at 2 years, as recommended in the Service Man... | Class II | GE Medical Systems, LLC |
| Nov 10, 2022 | Vivid S6 ultrasound. Used in ultrasound imaging and analysis in Fetal/Ob... | Potential for batteries that have not been replaced at 2 years, as recommended in the Service Man... | Class II | GE Medical Systems, LLC |
| Nov 9, 2022 | PPM LOMBARD PRODUCTS TSA 10PLT, CATALOG M1040 | 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 LISTERIA 60T, CATALOG 30700 | 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 HCG 60 TESTS, CATALOG 30405-01 | 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 CHROMID CARBA US 20 PLT, CATALOG 414012 | 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-GN80 TEST KIT 20 CARDS, CATALOG 413437 | As the temperature and time out of range was exceeded, product performances cannot be guaranteed | Class II | Biomerieux Inc |
| Nov 9, 2022 | ETEST CLINICAL AMIKACIN AK 256 US S30, CATALOG 412218 | As the temperature and time out of range was exceeded, product performances cannot be guaranteed | Class II | Biomerieux Inc |
| Nov 9, 2022 | ETEST CLINICAL RIFAMPICIN RI 32 US S30, CATALOG 412449 | 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-N801 TEST KIT 20 CARDS, CATALOG 423416 | As the temperature and time out of range was exceeded, product performances cannot be guaranteed | Class II | Biomerieux Inc |
| Nov 9, 2022 | BIOBALL B.SPIZIZENII NCTC 10400 550X20, CATALOG 56012 | As the temperature and time out of range was exceeded, product performances cannot be guaranteed | Class II | Biomerieux Inc |
| Nov 9, 2022 | ETEST CLINICAL MEROPENEM MP 32 US S30, CATALOG 412401 | As the temperature and time out of range was exceeded, product performances cannot be guaranteed | Class II | Biomerieux Inc |
| Nov 9, 2022 | ETEST CLINICAL ERAVACYCLINE ERV US S30, CATALOG 421553 | As the temperature and time out of range was exceeded, product performances cannot be guaranteed | Class II | Biomerieux Inc |
| Nov 9, 2022 | ETEST CLINICAL COLISTIN CO 256 US B100, CATALOG 537348 | 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/VABORBACTAM MEV US S30, CATALOG 421560 | 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 RUB IGG 60 TESTS, CATALOG 30226 | 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 VRE 20 PLT US, CATALOG 43851 | As the temperature and time out of range was exceeded, product performances cannot be guaranteed | Class II | Biomerieux Inc |
| Nov 9, 2022 | API LISTERIA 10 STRIPS+10 MEDIA, CATALOG 10300 | 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 NH TEST KIT VTK2 20 CARDS, CATALOG 21346 | 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-XN09 TEST KIT 20 CARDS, CATALOG 423425 | 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-DS, CATALOG 410893 | 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-GP78 TEST KIT 20 CARDS, CATALOG 421051 | 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 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 | 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 | 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 | 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 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 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 |
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.