Browse Device Recalls
2,276 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,276 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 2,276 FDA device recalls in 2022.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 | 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 | 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 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 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 | 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 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 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 | 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 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-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 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 | 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 | 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 | 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 | 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 | 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 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 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 8, 2022 | 9 Gauge Disposable Trocars with Blunt Pushers for Use with Subcutaneous Impla... | No expiration dates printed on the packaging | Class II | ENDO Pharmaceuticals Solutions, Inc. |
| Nov 8, 2022 | InPen Diabetes Management App, part of the InPen System, REF: MMT-105ELBLNA, ... | Diabetes management app may crash immediately upon opening, while using the app and/or while app ... | Class II | Companion Medical, Inc. |
| Nov 8, 2022 | FoundationOne Liquid CDx (F1LCDx), TECH-0009 version 6.0 | Reports were sent to customers without the companion diagnostic (CDx) Claims Page. Claims pages ... | Class II | Foundation Medicine, Inc. |
| Nov 8, 2022 | Corin BIOLOX DELTA MOD HEAD,032mm, EX LONG +7mm, REF 104.3215 | The BIOLOX Delta Ceramic Head size 36XL is labelled as the size 32XL and vice-versa. | Class II | Corin Ltd |
| Nov 8, 2022 | Corin BIOLOX DELTA MOD HEAD, 036mm EX LONG +8mm, REF 104.3615 | The BIOLOX Delta Ceramic Head size 36XL is labelled as the size 32XL and vice-versa. | Class II | Corin Ltd |
| Nov 8, 2022 | FoundationOne CDx (F1CDx), RAL-0003 version 31.0 | Reports were sent to customers without the companion diagnostic (CDx) Claims Page. Claims pages ... | Class II | Foundation Medicine, Inc. |
| Nov 7, 2022 | Cordis Angiographic Catheter Extensions. Used to transport fluid from th... | There is a potential for separation at the male connector. | Class II | Cordis US Corp |
| Nov 7, 2022 | Flow-c Anesthesia System (Product Code 6887700) Flow-e Anesthesia System (Pr... | The power backup battery, under certain conditions, may exhibit reduced battery run-time while in... | Class II | Getinge Usa Sales Inc |
| Nov 7, 2022 | R&D CBC-3D Hematology Control: (1) CBC-3D Normal Pack Hematology Control, ... | For one lot of CBC-3D Hematology Control, the Normal Level may exhibit hemolysis or deterioration... | Class III | R & D Systems, Inc. |
| Nov 7, 2022 | Tobra Full Dose CE Antibiotic Simplex P- Indicated for the fixation of prosth... | Instructions for Use (IFU) included in the packaging is missing a translation in the Turkish lan... | Class III | Howmedica Osteonics Corp. |
| Nov 7, 2022 | Full Dose CE Simplex P Single Bone Cement - Indicated for the fixation of pro... | Instructions for Use (IFU) included in the packaging is missing a translation in the Turkish lan... | Class III | Howmedica Osteonics Corp. |
| Nov 4, 2022 | HF Resection Electrodes, Model Numbers WA22602S, WA22603S, WA22621S and WA22657S | An incompatible HF cable may be packaged with the HF Resection Electrodes. This cable cannot be c... | Class II | Olympus Corporation of the Americas |
| Nov 4, 2022 | IMMULITE 2000 Systems 3gAllergy Specific IgE Universal Kit Tests OUS, excep... | Potential for falsely elevated specific IgE mold allergen reactivity with quality control materia... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Nov 4, 2022 | Medical Action INDUSTRIES INC. Port a Cath Kit REF 58647D, cardiac catheter i... | XXX | Class II | Medical Action Industries, Inc. 306 |
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.