Medical Device Recalls
This is our largest category by volume. The FDA tracks recalls for an enormous range of medical devices: implants, pacemakers, insulin pumps, surgical tools, blood glucose monitors, X-ray machines, prosthetics, contact lenses, and home health equipment, among many others. We have records dating back to 2005 and add new ones as the FDA publishes them.
Device recalls can happen because of software bugs, manufacturing defects, bacterial contamination, incorrect labeling, or design flaws that lead to inaccurate results or equipment failure. Class I recalls are the most serious and mean the device could cause injury or death.
Showing 9241–9260 of 38,428 recalls
Recalled Item: ETEST CLINICAL COLISTIN CO 256 US B100
The Issue: As the temperature and time out of range
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ETEST CLINICAL ETEST MEROPENEM/VABORBACTAM MEV US S30
The Issue: As the temperature and time out of range
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VIDAS CLINICAL VIDAS RUB IGG 60 TESTS
The Issue: As the temperature and time out of range
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PPM CLINICAL CRAPONNE CHROMID VRE 20 PLT US
The Issue: As the temperature and time out of range
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: API LISTERIA 10 STRIPS+10 MEDIA
The Issue: As the temperature and time out of range
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITEK 2 REAGENT NH TEST KIT VTK2 20 CARDS
The Issue: As the temperature and time out of range
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITEK 2 REAGENT AST-XN09 TEST KIT 20 CARDS
The Issue: As the temperature and time out of range
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITEK MS CLINICAL REAGENT VITEK MS-DS
The Issue: As the temperature and time out of range
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITEK 2 REAGENT AST-GP78 TEST KIT 20 CARDS
The Issue: As the temperature and time out of range
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PPM LOMBARD PRODUCTS IRR COUNT-TACT 3P AGAR 100 PLT
The Issue: As the temperature and time out of range
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ETEST CLINICAL ETEST MEROPENEM MP M100 US
The Issue: As the temperature and time out of range
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PPM CLINICAL CHROMID MRSA 20 PLT US
The Issue: As the temperature and time out of range
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ETEST CLINICAL CEFTAZIDIM/AVIBACTAM US S30
The Issue: As the temperature and time out of range
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITEK 2 REAGENT AST-GN79 TEST KIT 20 CARDS
The Issue: As the temperature and time out of range
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ETEST CLINICAL MINOCYCLINE MC 256 US S30
The Issue: As the temperature and time out of range
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VIDAS CLINICAL VIDAS SALMONELLA 60T
The Issue: As the temperature and time out of range
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PPM LOMBARD PRODUCTS TSA 3P W NEUTRALIZERS 100 PLT
The Issue: As the temperature and time out of range
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TEMPO REAGENTS TEMPO CONTROL KIT
The Issue: As the temperature and time out of range
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: API 20 C AUX 25 STRIPS+25 MEDIA
The Issue: As the temperature and time out of range
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITEK 2 REAGENT AST-GN81 TEST KIT 20 CARDS
The Issue: As the temperature and time out of range
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.