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 19341–19360 of 38,428 recalls
Recalled Item: Optiflux F160NR Capillary High Flux Dialyzer Single Use Only
The Issue: for external blood leaks from the dialyzer
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: enVista One Piece Hydrophobic Acrylic Intraocular lens - Is indicated
The Issue: Cosmetic imperfections on the surface of some lenses
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Captus 700 Thyroid Uptake System
The Issue: There is a potential for the spring arm
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Captus 3000 Thyroid Uptake System
The Issue: There is a potential for the spring arm
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GEM Coupler Forceps
The Issue: presence of rust on Coupler Forceps (GEM4183C)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SonoSite FUJIFILM Needle Guide Bracket Recalled by CIVCO Medical Instruments...
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CIVCO Sales Demo Kit Recalled by CIVCO Medical Instruments Co., Inc. Due to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CIVCO Biopsy Bracket Recalled by CIVCO Medical Instruments Co., Inc. Due to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SonoSite Needle Guide Bracket Recalled by CIVCO Medical Instruments Co.,...
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CIVCO Needle Guide Starter Kit Recalled by CIVCO Medical Instruments Co.,...
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CIVCO Needle Guide Bracket Recalled by CIVCO Medical Instruments Co., Inc....
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CIVCO Needle Guide Starter Kit Recalled by CIVCO Medical Instruments Co.,...
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SonoSite L25 Bracket Kit containing 1 Reusable non-sterile bracket
The Issue: The needle guide bracket may puncture the sterile
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CIVCO Needle Guide Starter Kit Recalled by CIVCO Medical Instruments Co.,...
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CIVCO Needle Guide Starter Kit Recalled by CIVCO Medical Instruments Co.,...
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CIVCO Needle Guide Bracket
The Issue: The needle guide bracket may puncture the sterile
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CIVCO Needle Guide Bracket
The Issue: The needle guide bracket may puncture the sterile
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CIVCO Needle Guide Starter Kit Recalled by CIVCO Medical Instruments Co.,...
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CIVCO Needle Guide Starter Kit Recalled by CIVCO Medical Instruments Co.,...
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CIVCO Needle Guide Bracket Recalled by CIVCO Medical Instruments Co., Inc....
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.