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 16821–16840 of 38,428 recalls
Recalled Item: Pacific Medical GE Corometrics Nautilus Toco Transducer w/knob
The Issue: Fetal transducers distributed in advance of receiving 510(k)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Pacific Medical GE Corometrics Nautilus Ultrasound
The Issue: Fetal transducers distributed in advance of receiving 510(k)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MotoBand CP
The Issue: Potentially includes a 3.0mm x 30mm screw instead
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Forte Gamma Camera System is intended to produce images depicting
The Issue: An issue with the Detector for the Forte
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Forte Gamma Camera System is intended to produce images depicting
The Issue: An issue with the Detector for the Forte
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Forte Gamma Camera System is intended to produce images depicting
The Issue: An issue with the Detector for the Forte
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Forte Gamma Camera System is intended to produce images depicting
The Issue: An issue with the Detector for the Forte
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Forte Gamma Camera System is intended to produce images depicting
The Issue: An issue with the Detector for the Forte
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TherMax Blood Warmer Unit
The Issue: TherMax Blood Warmers may not be in compliance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Electrosurgical Tip Cleaner Product Usage: electrosurgical accessory
The Issue: The sterile barrier of some devices may have
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cautery Tip Cleaner Product Usage: electrosurgical accessory
The Issue: The sterile barrier of some devices may have
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Electrosurgical Tip Cleaner Product Usage: electrosurgical accessory
The Issue: The sterile barrier of some devices may have
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: iLab Polaris Multi-Modality Guidance System
The Issue: Certain iLab Polaris Systems which were upgraded with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: In-the-Ear hearing aids
The Issue: GN Hearing received reports from our manufacturing site
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EVENCARE G3 Blood Glucose Test Strips
The Issue: Incomplete seal and premature expiration of individually packaged
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Behind-the-Ear hearing aids
The Issue: GN Hearing received reports from our manufacturing site
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BIOFLO 8F SINGLE TITANIUM NON- FILLED
The Issue: Snap lock connectors provided within implantable port kits
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BIOFLO 8F SINGLE PLASTIC FILLED
The Issue: Snap lock connectors provided within implantable port kits
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BIOFLO 8F SINGLE PLASTIC FILLED
The Issue: Snap lock connectors provided within implantable port kits
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: XCELA
The Issue: Snap lock connectors provided within implantable port kits
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.