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 13761–13780 of 38,428 recalls
Recalled Item: Greffe Aorte-LF (product info is in French)
The Issue: The cylindrical sponge component is not x-ray detectable
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Simple Neck Dissection
The Issue: The cylindrical sponge component is not x-ray detectable
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Randox Mg R1 - Product Usage: For the quantitative in
The Issue: Failing to meet the linearity performance claims quoted
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Randox Rx Series Mg - Product Usage: For the quantitative
The Issue: Failing to meet the linearity performance claims quoted
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CareLink Personal Software Therapy Management Software Tool for Diabetes...
The Issue: Incomplete basal rate information may be transmitted leading
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic Intellis Spinal Cord Stimulator
The Issue: A710 Intellis Clinician Application has a software issue
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Infinity ACL Tibial Tip Guide- indicated for use in open
The Issue: Tips of the Infinity ACL Tibial Elbow and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Infinity ACL Tibial Elbow Guide-indicated for use in open and
The Issue: Tips of the Infinity ACL Tibial Elbow and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stimulan Kit 10cc
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VNS Therapy SENTIVA DUO # 1000-D - Product Usage: indicated
The Issue: During internal testing, it was found that upon
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Life2000 Ventilation System
The Issue: Under certain conditions, there is a risk for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Canon PET-CT SCANNER
The Issue: A software problem has been identified which could
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item:
The Issue: There is a potential that the fitment between
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: (Adult Elongated O2/CO2 Mask - Product Usage: intended
The Issue: There is a potential that the fitment between
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Smoothbore breathing system with exhalation port 22 mm Device REF
The Issue: The device was assembled with the incorrect exhalation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Adult Elongated CO2/O2 Mask
The Issue: There is a potential that the fitment between
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item:
The Issue: There is a potential that the fitment between
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item:
The Issue: There is a potential that the fitment between
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Westmed DISPOSABLE RESPIRATORY PRODUCTS NON-REBREATHER MASK
The Issue: There is a potential that the fitment between
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: (1) Capiox FX25 (West) Advance Oxygenator- with left port
The Issue: Capiox FX25 Advance oxygenator may be the incorrect
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.