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 41–60 of 38,428 recalls
Recalled Item: CS100 IABP. Software Version CS100 IABP Q.01.
The Issue: The firm has identified that the battery runtime
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PHYSIO CONTROL INFANT/CHILD Reduced Energy Defibrillator Electrodes Catalog...
The Issue: Due to pediatric defibrillator electrode delamination
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EVO+ Visian Toric Implantable Collamer Lens (TICL)
The Issue: Toric Implantable Collamer for correction/reduction of myopia in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Adapt Pump
The Issue: Agiliti identified an issue where the Adapt Pump
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MONARCH Platform
The Issue: Device for bronchoscopic visualization, patient airway access has
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MOLLI 2 System System includes: MM1000 (Pack of 10) - MOLLI Introducer (8cm
The Issue: Due to a need to update the product
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GEM Premier 5000 PAK
The Issue: Confirmed customer complaints indicating that GEM PAKs (cartridges)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GEM Premier 5000
The Issue: Confirmed customer complaints indicating that GEM PAKs (cartridges)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GEM Premier 5000
The Issue: Confirmed customer complaints indicating that GEM PAKs (cartridges)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GEM Premier 5000
The Issue: Confirmed customer complaints indicating that GEM PAKs (cartridges)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GEM Premier 5000
The Issue: Confirmed customer complaints indicating that GEM PAKs (cartridges)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GEM Premier 5000 PAK
The Issue: Confirmed customer complaints indicating that GEM PAKs (cartridges)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GEM Premier 5000 PAK
The Issue: Confirmed customer complaints indicating that GEM PAKs (cartridges)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GEM Premier 5000 PAK
The Issue: Confirmed customer complaints indicating that GEM PAKs (cartridges)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GEM Premier 5000
The Issue: Confirmed customer complaints indicating that GEM PAKs (cartridges)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GEM Premier 5000 PAK
The Issue: Confirmed customer complaints indicating that GEM PAKs (cartridges)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GEM Premier 5000 PAK
The Issue: Confirmed customer complaints indicating that GEM PAKs (cartridges)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GEM Premier 5000
The Issue: Confirmed customer complaints indicating that GEM PAKs (cartridges)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GEM Premier 5000
The Issue: Confirmed customer complaints indicating that GEM PAKs (cartridges)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GEM Premier 5000
The Issue: Confirmed customer complaints indicating that GEM PAKs (cartridges)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.