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 9121–9140 of 38,428 recalls
Recalled Item: HeartWare HVAD Pump Kit
The Issue: Over time, the driveline cover may become hardened,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Products are labeled as: Skippack Medical Lab SARS-CoV-2 Antigen Rapid
The Issue: Distribution of SARS-CoV-2 Antigen Rapid Test Kits without
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DeRoyal Tonsillectomy Tray
The Issue: DeRoyal is recalling certain lots of surgical procedure
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alinity Reaction Vessels
The Issue: Reaction vessels may contain a potential contaminant that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RSDL (Reactive Skin Decontamination Lotion) Kit
The Issue: Complaints of leaking packets were received
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Luminos Agile Max (VE10
The Issue: Under certain unlikely circumstances during a fluoroscopic examination,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Luminos dRF Max (VE10
The Issue: Under certain unlikely circumstances during a fluoroscopic examination,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LUMINOS Lotus Max (VF11)
The Issue: Under certain unlikely circumstances during a fluoroscopic examination,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: COVIDIEN Emprint Ablation Catheter with Thermosphere Technology
The Issue: The product is labeled with the incorrect expiration
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Revaclear 300 dialyzers. Indicated for treatment of chronic and acute
The Issue: Reports of Polyurethane Displacement in the dialyzer, and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Revaclear 400 dialyzers. Indicated for treatment of chronic and acute
The Issue: Reports of Polyurethane Displacement in the dialyzer, and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Revaclear 400 Dialyzer. Product Code: 114749M. Not distributed in the
The Issue: for Internal Blood Leaks due to a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Revaclear 400 Dialyzer. Product Code: 114746L. Used to treat chronic
The Issue: for Internal Blood Leaks due to a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Revaclear 400 dialyzers. Indicated for treatment of chronic and acute
The Issue: Reports of Polyurethane Displacement in the dialyzer, and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Liquid Assayed Specific Protein Control Level 2- In vitro diagnostic use
The Issue: Concentration of Rheumatoid Factor has decreased in Specific
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Liquid Assayed Specific Protein- In vitro diagnostic use
The Issue: Concentration of Rheumatoid Factor has decreased in Specific
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Liquid Assayed Specific Protein Control Level 3- In vitro diagnostic use
The Issue: Concentration of Rheumatoid Factor has decreased in Specific
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Abbott Alinity m Resp-4-Plex Amp Kit
The Issue: Reports of an increase in reactive negative controls
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Abbott Alinity m Resp-4-Plex Amp Kit
The Issue: Reports of an increase in reactive negative controls
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips SmartPath to Ingenia Elition X MR System
The Issue: Gradient Coil may act as a heat source
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.