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 13981–14000 of 38,428 recalls
Recalled Item: VNS Therapy¿ AspireSR¿ Generator
The Issue: Due to an extra digit being inadvertently added
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AB PowerCel 170 (velvet black)
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AB PowerCel 230 (velvet black)
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Osteosynthesis Compression Staple EasyClip
The Issue: The device has the potential to release nickel
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: QUIDEL Sofia SARS Antigen FIA IVD
The Issue: Due to false positive results
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Covidien MONOJECT Standard Hypodermic Needle
The Issue: for the needle to detach from the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Equinoxe Platform Fracture Stem
The Issue: The device may be incorrectly laser marked as
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Equinoxe Platform Fracture Stem
The Issue: The device may be incorrectly laser marked as
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene
The Issue: Sterilant (hydrogen peroxide) used in acetabular cup hip
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene
The Issue: Sterilant (hydrogen peroxide) used in acetabular cup hip
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene
The Issue: Sterilant (hydrogen peroxide) used in acetabular cup hip
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene
The Issue: Sterilant (hydrogen peroxide) used in acetabular cup hip
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AMS 700 MS Pump with and without InhibiZone
The Issue: The recalling firm has observed an increase in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene
The Issue: Sterilant (hydrogen peroxide) used in acetabular cup hip
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene
The Issue: Sterilant (hydrogen peroxide) used in acetabular cup hip
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene
The Issue: Sterilant (hydrogen peroxide) used in acetabular cup hip
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene
The Issue: Sterilant (hydrogen peroxide) used in acetabular cup hip
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene
The Issue: Sterilant (hydrogen peroxide) used in acetabular cup hip
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene
The Issue: Sterilant (hydrogen peroxide) used in acetabular cup hip
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene
The Issue: Sterilant (hydrogen peroxide) used in acetabular cup hip
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.