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 24541–24560 of 38,428 recalls
Recalled Item: Anthrex SpeedBridge Implant System with PEEK SwiveLock Self Punching
The Issue: Some eyelets broke from SwiveLock Anchor on insertion
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dale Medical Stabilock Endotracheal Adhesive Base Product # 273 The
The Issue: ET Tube Holders contain an adhesive faceplate that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dale Medical Stabilock Endotracheal Tube Holder Product # 270 The
The Issue: ET Tube Holders contain an adhesive faceplate that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Blood Agar (TSA w/ 5% Sheep Blood) Plate
The Issue: Listeria Contamination
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Toshiba Medical Radrex - i Digital Radiography X-ray system Radrex-i
The Issue: It was discovered during a procedure that when
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Omega Medical Imaging - 2 over 2 Elevating Monitor Suspension
The Issue: Elevating Monitor Suspension column dropping and will not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sysmex
The Issue: Reported customer complaints of automated hematology analyzers catching
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 1 mL Medallion¿ Syringe. Catalog Numbers: 701989001
The Issue: Merit Medical Systems announces a voluntary field action
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AIA-360 Analyzer is capable of performing two methods of immunoassay:
The Issue: The firm has become aware of a potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Zenith Alpha Thoracic Endovascular Graft The Zenith Alpha" Thoracic Endovascular
The Issue: There have been five reports of graft thrombosis/occlusion
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Wingman 35 Crossing Catheter
The Issue: ReFlow Medical is recalling the Wingman 35 Crossing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NC Trek RX Coronary Dilatation Catheter
The Issue: Products from the identified lots may exhibit difficulty
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NC Traveler RX Coronary Dilatation Catheter
The Issue: Products from the identified lots may exhibit difficulty
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NC Tenku RX PTCA Balloon Catheter
The Issue: Products from the identified lots may exhibit difficulty
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Regenerex Patella RGX 3 PEG SER A PATELLA 28MM RGX
The Issue: pegs shearing post-operatively
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PERI-LOC VOLAR DISTAL RADIUS - RIGHT 3H STD HEAD LOCKING PLATE
The Issue: This lot of left plates were laser etched
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Allura Xper Release 8.2 (Laird chiller is always installed)
The Issue: Due to a leak in the detector cooling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The following systems are only affected if a Laird chiller
The Issue: Due to a leak in the detector cooling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: UNIQ: UNIQ FD10 722026
The Issue: Due to a leak in the detector cooling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dimension Vista Thyroid Stimulating Hormone (TSH) Flex reagent cartridge
The Issue: The concentrations for Biotin listed in the Non-Interfering
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.