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 281–300 of 38,428 recalls
Recalled Item: Fixone Biocomposite Anchor
The Issue: Reports of device failure, including anchor breakage, anchor
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Fixone Hybrid Anchor
The Issue: Reports of device failure, including anchor breakage, anchor
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Genesis Knotless Anchor
The Issue: Reports of device failure, including anchor breakage, anchor
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AlternatiV+ Max Knotless Anchor
The Issue: Reports of device failure, including anchor breakage, anchor
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Genesis Dual Thread Screw-In Anchor
The Issue: Reports of device failure, including anchor breakage, anchor
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Genesis Screw-In Anchor
The Issue: Reports of device failure, including anchor breakage, anchor
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2.
The Issue: There may be voids located in the seal
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vortex Surgical 1. 23GA Laser Probe Curved Cat No. VS0120.23
The Issue: There may be voids located in the seal
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vortex Surgical I2 Injection Kit
The Issue: There may be voids located in the seal
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vortex Surgical TID Pharos Illuminated Depressor
The Issue: XXX
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vortex Surgical 25GA Backflush
The Issue: There may be voids located in the seal
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Oertli 1. 23G Laser Probe OS4 Flex-Tip VK401113 2. 23G
The Issue: There may be voids located in the seal
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vortex Surgical 25GA I.D.D. Internal Delivery Device
The Issue: There may be voids located in the seal
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Tecfen Retractable Membrane Polisher
The Issue: There may be voids located in the seal
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 25GA Subretinal Injection Cannula VS0220.25
The Issue: There may be voids located in the seal
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vortex Disposable Forceps and Cannula 1. 23GA ACTU8 Forceps Adaptive
The Issue: There may be voids located in the seal
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Volk Single Use Vitrectomy Lenses 1. Flat Vitrectomy Lens
The Issue: There may be voids located in the seal
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Rumex Disposable Diamond Dusted ILM Elevator
The Issue: There may be voids located in the seal
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vortex Surgical Lindsell Sutured IOL Marker
The Issue: There may be voids located in the seal
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medline medical procedure convenience kits labeled as: KIT ROBOTICS UROLOGY
The Issue: Medline kits containing Stryker's Strykeflow 2 Suction Irrigators
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.