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 23961–23980 of 38,428 recalls
Recalled Item: Boston Scientific Zurpaz(TM) MEDIUM CURL
The Issue: Lack of sterility assurance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Boston Scientific Zurpaz(TM) MEDIUM CURL
The Issue: Lack of sterility assurance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Neusoft Medical NeuViz 64 Multi-slice CT Scanner System
The Issue: Software defect
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Neusoft NeuViz 128 Multi-slice CT Scanner System Product Usage: The
The Issue: Software defect
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Pacific Hemostasis FDP (Fibrinogen Degradation Products) Assay Kit (30...
The Issue: An issue was discovered with the Pacific Hemostasis
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Pacific Hemostasis FDP Latex Reagent
The Issue: An issue was discovered with the Pacific Hemostasis
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medacta GMK HINGE
The Issue: One lot of product does not include a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BioGlue Surgical Adhesive
The Issue: The courtesy labels in 9 boxes of BioGlue
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare Optima CT520 X-ray system
The Issue: It was discovered that an issue has been
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare lnnova IGS 540 ACT X-ray system
The Issue: It was discovered that an issue has been
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare BrightSpeed X-ray system
The Issue: It was discovered that an issue has been
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare Discovery NM/CT 570c X-ray system
The Issue: It was discovered that an issue has been
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare Discovery NM/CT 670. 670 Pro
The Issue: It was discovered that an issue has been
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare Discovery Ml DR X-ray system
The Issue: It was discovered that an issue has been
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare Optima CT540 X-ray system
The Issue: It was discovered that an issue has been
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare Discovery IQ X-ray system
The Issue: It was discovered that an issue has been
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare Optima CT580
The Issue: It was discovered that an issue has been
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare LightSpeed VCT X-ray system
The Issue: It was discovered that an issue has been
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare Lightspeed RT16 X-ray system
The Issue: It was discovered that an issue has been
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare Discovery Ml X-ray system
The Issue: It was discovered that an issue has been
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.