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 1761–1780 of 38,428 recalls
Recalled Item: Orascoptic Superior Visualization Custom loupes configured with Phantom Frames
The Issue: Due to complaints, loupe nose pads containing nickel
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: L17-5 Transducer Probe
The Issue: To provide clarification and labelling to define the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: C10-3v Transducer Probe
The Issue: To provide clarification and labelling to define the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Orascoptic Superior Visualization Phantom Essential kit ( Nose pad
The Issue: Due to complaints, loupe nose pads containing nickel
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: S8-3 Transducer Probe
The Issue: To provide clarification and labelling to define the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: S12-4 Transducer Probe
The Issue: To provide clarification and labelling to define the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: S7-2t Transducer Probe
The Issue: To provide clarification and labelling to define the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: X3-1 Transducer Probe
The Issue: To provide clarification and labelling to define the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE HealthCare OEC 9800.
The Issue: GE HealthCare has become aware of a non-conformance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE HealthCare OEC 9900 Elite C-arm Systems.
The Issue: GE HealthCare has become aware of a non-conformance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sparrow Ascent Patient Controller
The Issue: Due to manufacturing issue, neurostimulator device may experience
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stryker SmartPump Tourniquet
The Issue: Tourniquet cuff flange may become detached from the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: JUNCTIONAL EMERGENCY TREATMENT TOOL (JETT)
The Issue: Device used for unilateral or bilateral occlusion of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Carefree Surgical Specialties Product Name: Robotic/Laparoscopy Kittner Rolls
The Issue: Due to two issues: 1. Product contamination (biological
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Carefree Surgical Specialties Product Name: Robotic/Laparoscopy Kittner Roll
The Issue: Due to two issues: 1. Product contamination (biological
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Carefree Surgical Specialties Product Name: Robotic/Laparoscopy Kittner Rolls
The Issue: Due to two issues: 1. Product contamination (biological
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Carefree Surgical Specialties Product Name: Robotic/Laparoscopy Kittner +
The Issue: Due to two issues: 1. Product contamination (biological
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Evolution Upgrade 3.0T Model Numbers (REF): (1) 782117
The Issue: The potential for component failures in the Gradient
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Evolution Upgrade 1.5T Model Numbers (REF): (1) 782116
The Issue: The potential for component failures in the Gradient
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Intera 3.0T Quasar Dual Model Number (REF): 781150
The Issue: The potential for component failures in the Gradient
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.