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 20021–20040 of 38,428 recalls
Recalled Item: Bausch + Lomb Stellaris Elite Vision Enhancement System
The Issue: The back cap separates from the body of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Bausch + Lomb Stellaris Elite Vision Enhancement System
The Issue: The back cap separates from the body of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Bausch + Lomb Stellaris Elite Vision Enhancement System
The Issue: The back cap separates from the body of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Minimed Model 503 Remote Transmitter (MMT-503
The Issue: There is a potential security vulnerability related to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Minimed Model 500 Remote Control (MMT-500
The Issue: There is a potential security vulnerability related to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ImplantDirect simply RePlant Implant
The Issue: The incorrect device was packaged in the vial
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ysio MAX (model number 10762470) with Tube stand 3D V
The Issue: In rare cases of high clinical workload, the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ysio (model number 10281013 or 10281163) with Tube stand 3D
The Issue: In rare cases of high clinical workload, the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AXIOM Multix MT (model number 8395415 or 8395399 or 8395381)
The Issue: In rare cases of high clinical workload, the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Polyisoprene condomns Product Usage: The Durex Synthetic polyisoprene male...
The Issue: Product marketed in U.S. does not have sufficient
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Laparoscopy Instruments Instructions For Use (IFU) for the following:...
The Issue: The Manual cleaning process and the usability of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Multix Fusion system is a radiographic system: Models: Multix Fusion
The Issue: Steel cables inside the lifting column of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Enterprise Imaging Desktops Enterprise Imaging Desktops (Radiology...
The Issue: Adding an additional comparison study to the Clinical
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Biomet Sports Medii cine Juggerknot Long Flex Drill Bit with
The Issue: Expiration date incorrectly listed on the label
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Xper Flex Cardio Physiomonitoring System Model # 453564669081 Software Version
The Issue: Released with an incorrect, older firmware version installed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MOSAIQ Oncology Information System
The Issue: Order Status Remains Approved When Should Indicate Complete
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CINtec p16 Histology (250)
The Issue: Leaking and sticking reagent dispensers for horseradish peroxidase
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Campylobacter Blood Free Selective Medium
The Issue: The product is labeled with an incorrect expiration
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Palcam Agar Base
The Issue: Expiration date on the label is incorrect. Correct
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vanguard 360 Revision Knee System 75x 5mm Universal Tibial Block Augment
The Issue: The implant only has one bolt in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.