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 9261–9280 of 38,428 recalls
Recalled Item: VITEK 2 REAGENT AST-GP75 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 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: PPM CLINICAL CRAPONNE CLINICAL CHROMID CANDIDA 20 PLATES
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 CT&TI-TSA + L & P80 10PLT
The Issue: As the temperature and time out of range
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GENE-UP REAGENT GENE-UP Salmonella 2
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 CEFTRIAXONE TX 32 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: PPM LOMBARD PRODUCTS R2A MEDIUM 10PLT
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 QCV-QUALITY CONTROL VIDAS 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 INDUSTRY COMBOURG LPT BROTH (4X3L)
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 S AUREUS 20PLT US
The Issue: As the temperature and time out of range
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GENE-UP REAGENT GENE-UP LYSIS KIT
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 IP 32 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: PREVI COLOR GRAM REAGENT NOZZLE CLEANING SOLUTION (NA)
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-ST02 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 2 REAGENT AST-GN99 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: API NIT1 NIT2 REAGENTS
The Issue: As the temperature and time out of range
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BIOBALL A.BRASILIENSIS NCPF 2275 550X20
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 TOBRAMYCIN TM 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-XN15 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 CLINICAL CHROMID STREPTO B US 20 PLT
The Issue: As the temperature and time out of range
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.