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 9221–9240 of 38,428 recalls
Recalled Item: Vivid S6 ultrasound. Used in ultrasound imaging and analysis in
The Issue: for batteries that have not been replaced
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vivid S5 N ultrasound. Not marketed in the US. Used
The Issue: for batteries that have not been replaced
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vivid S5 Ultrasound. Used in ultrasound imaging and analysis in
The Issue: for batteries that have not been replaced
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vivid i ultrasound. Marketed under the following 510(k) numbers: K033139
The Issue: for batteries that have not been replaced
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vivid q ultrasound. Used in ultrasound imaging and analysis in
The Issue: for batteries that have not been replaced
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vivid q N ultrasound. Not marketed in the US. Used
The Issue: for batteries that have not been replaced
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: X-CORE 2 Ti Core
The Issue: that insert will be unable to disengage
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vivid S6 N ultrasound. Not marketed in the US. Used
The Issue: for batteries that have not been replaced
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vivid i N ultrasound. Not marketed in the US. Used
The Issue: for batteries that have not been replaced
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ETEST CLINICAL AMIKACIN AK 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-GN80 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 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 VIDAS LISTERIA 60T
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 HCG 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 CHROMID CARBA US 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 RIFAMPICIN RI 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: VITEK 2 REAGENT AST-N801 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: BIOBALL B.SPIZIZENII NCTC 10400 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 MEROPENEM MP 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: ETEST CLINICAL ERAVACYCLINE ERV US S30
The Issue: As the temperature and time out of range
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.