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 32841–32860 of 38,428 recalls
Recalled Item: Aqua 540 SW
The Issue: The seals of the adaptor packaging may be
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Aquapak 340 SW
The Issue: The seals of the respiratory gas humidifier adaptor
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Aquapak 340 SW
The Issue: The seals of the adaptor packaging may be
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Aquapak SW/EAU Sterile
The Issue: The seals of the adaptor packaging may be
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Aquapak 640 SW
The Issue: The seals of the adaptor packaging may be
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Aquapak SW/EAU
The Issue: The seals of the adaptor packaging may be
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Aquapak 340 SW
The Issue: The seals of the adaptor packaging may be
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ROSA Surgical Device 2.5.8 It is intended to be used
The Issue: Software corrections reactivating the cooperative endoscopy mode
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DeRoyal Cardiac Hypothermia Tray
The Issue: The firm distributed surgical kits which contained Irrigation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DeRoyal KNEE ARTHROSCOPY PACK
The Issue: The firm distributed surgical kits which contained Irrigation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: InTouch Critical Care Bed
The Issue: Stryker has received complaints from the field alleging
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PALL Medical Breathing Circuit Filter
The Issue: leak from the filter allowing a small
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare
The Issue: GE Healthcare has become aware of a potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare
The Issue: GE Healthcare has become aware of a potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stride Femoral Component Size 2
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stride Femoral Component Size 2
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Model Number(s): PB840 Ventilator (4-840120DIUU-XX). The product is a component
The Issue: In the case of a loss of GUI
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: eye-pak 7407 Tray Support Cover
The Issue: The peel pouches of the Tray Support Covers
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RECLAIM DISTAL TAPERED
The Issue: The product can be difficult to remove from
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RECLAIM Taper Protector Sleeve. RECLAIM Revision Hip System Orthopedic Manual
The Issue: The product can be difficult to remove from
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.