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 7541–7560 of 38,428 recalls
Recalled Item: Calibrate (Cs-137) nanoDot D2DNS
The Issue: LANDAUER received reports indicating that some nanoDots may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: QC (80 kVp) nanoDot D2DNS
The Issue: LANDAUER received reports indicating that some nanoDots may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: nanoDot D2DNS
The Issue: LANDAUER received reports indicating that some nanoDots may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Calibrate (Cs-137) nanoDot D2DNS
The Issue: LANDAUER received reports indicating that some nanoDots may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: nanoDot D2DXN
The Issue: LANDAUER received reports indicating that some nanoDots may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: nanoDot D2DNN
The Issue: LANDAUER received reports indicating that some nanoDots may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Calibrate (unexposed) nanoDot D2DNS
The Issue: LANDAUER received reports indicating that some nanoDots may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Calibrate (80 kVp) nanoDot D2DNS
The Issue: LANDAUER received reports indicating that some nanoDots may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: nanoDot D2DNN
The Issue: LANDAUER received reports indicating that some nanoDots may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NanoDots
The Issue: LANDAUER received reports indicating that some nanoDots may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Beckman Coulter
The Issue: Lipemic interference failed to meet the performance specification
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The Air/Water Valve is provided/used with the following Endoscopes: ULTRASONIC
The Issue: The air/water valve MAJ-1444 used with OER-Pro and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IMPIX S
The Issue: There is a potential for a product packaging
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IMPIX C+
The Issue: There is a potential for a product packaging
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IMPIX MANTA
The Issue: There is a potential for a product packaging
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Carina Sub-Acute Care Ventilator
The Issue: Presence of polyether polyurethane (PE-PUR) and emission of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IMPIX ALIF
The Issue: There is a potential for a product packaging
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GRANVIA-C
The Issue: There is a potential for a product packaging
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IMPIX MANTA+
The Issue: There is a potential for a product packaging
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IMPIX DLIF
The Issue: There is a potential for a product packaging
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.