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 2581–2600 of 38,428 recalls
Recalled Item: Monterey AL Implant Inserter
The Issue: for the gold unlock button to separate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Monterey AL Implant Inserter
The Issue: for the gold unlock button to separate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Spectral CT on Rails
The Issue: Multiple problems identified with the software version leading
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Access Vitamin B12 Reagent
The Issue: Beckman Coulter has received complaints of erroneous Vitamin
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: t:slim X2 Insulin Pump with Interoperable Technology
The Issue: A software defect in Version 7.9 of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Tandem Mobi Insulin Pump with Interoperable Technology
The Issue: A software defect in Version 7.9 of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FilmArra Pneumonia Panel plus (Pneumoplus)
The Issue: Increased risk of control failures and false negative
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Premier Solo Diamond - Large Invented Cone
The Issue: The hardness not meeting the material specification and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Brand Names: MyDay Toric
The Issue: a limited number of lots were manufactured with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NexGen LPS Flex
The Issue: The "Use with plate 7, 8, 9, 10"
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hippo 072 Aspiration System including Cheetah Delivery Tool and Aspiration
The Issue: Aspiration catheter distal tip features and characteristics may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DxC 500 AU Clinical Chemistry Analyzer
The Issue: Beckman Coulter has determined that device software versions
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff Reusable Inner
The Issue: Tracheostomy tube with cuff reusable inner cannula has
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Da Vinci 5 Product Name: ASSY
The Issue: Due to an increase in complaints concerning foot
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Veradius Unity. Product Code 718132. The devices are used for
The Issue: A wireless foot switch pedal may get stuck
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Zenition 70. Product Code 718133. The devices are used for
The Issue: A wireless foot switch pedal may get stuck
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Zenition 50. Product Code 718096. The devices are used for
The Issue: A wireless foot switch pedal may get stuck
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Otopore Cylinder outer ear wound dressing
The Issue: There is a potential for blister seals on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Nasopore FD fragmentable nasal dressing
The Issue: There is a potential for blister seals on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Otopore Square outer ear wound dressing
The Issue: There is a potential for blister seals on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.