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 9281–9300 of 38,428 recalls
Recalled Item: BIOBALL K.RHIZOPHILA (30X20)
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-GN70 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 VANCOMYCIN VA 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: VITEK 2 REAGENT BCL 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 MS CLINICAL REAGENT VITEK MS-CHCA
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 C.DIFFICILE 20 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 VANCOMYCIN VA 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: VITEK 2 REAGENT AST-GP67 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 IMIPENEM RELEBACTAM IPR 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 ESTRADIOL II 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 INDUSTRY COMBOURG BACARA 20PLATES 90MM
The Issue: As the temperature and time out of range
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: API VP1 VP2 REAGENTS
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 T PHOSPHATE BUFFERSTERILE 20X9ML
The Issue: As the temperature and time out of range
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: API JAMES 2AMP
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 AMOXI/CLAV 2/1 XL 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: VITEK 2 REAGENT AST-GN69 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: VIDAS CLINICAL VIDAS LH 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: ETEST CLINICAL BENZYLPENICIL PG 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: VITEK 2 REAGENT GN 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: ASTUTE REAGENT NEPHROCHECK LIQUID CONTROLS KIT US
The Issue: As the temperature and time out of range
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.