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 2661–2680 of 38,428 recalls
Recalled Item: GE Healthcare Revolution CT ES
The Issue: GE HealthCare has become aware of a potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Care Coordination Engine (CCE) Infusion Adapter
The Issue: Software issue that may result in outdated automated
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare Revolution Apex Expert
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 Revolution Apex Plus
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 Revolution Apex Elite
The Issue: GE HealthCare has become aware of a potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Initiation 18 Coated Regular and 18 Coated Super Tampons
The Issue: Product lacks 510(k) clearance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Initiation 18 Coated Regular and 18 Nude Regular Tampons
The Issue: Product lacks 510(k) clearance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 18 Coated Regular and 18 Nude Regular Tampons
The Issue: Product lacks 510(k) clearance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 3 Month All in One Bundle
The Issue: Product lacks 510(k) clearance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 9 Coated Super Tampons and 9 Nude Super Tampons
The Issue: Product lacks 510(k) clearance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 3 Month Regular Flow Bundle
The Issue: Product lacks 510(k) clearance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 18 Coated Regular Tampons
The Issue: Product lacks 510(k) clearance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Initiation 36 Coated Regular Tampons
The Issue: Product lacks 510(k) clearance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 9 Coated Super and 9 Nude Super Tampons
The Issue: Product lacks 510(k) clearance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Initiation 3 Month Trial Tampon Box
The Issue: Product lacks 510(k) clearance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Initiation 3 Month All in One Bundle
The Issue: Product lacks 510(k) clearance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Initiation 36 Coated Super Tampons
The Issue: Product lacks 510(k) clearance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Trial Tampon Box
The Issue: Product lacks 510(k) clearance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Initiation 3 Month Regular Flow Bundle
The Issue: Product lacks 510(k) clearance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Heavy Flow Bundle
The Issue: Product lacks 510(k) clearance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.