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 35741–35760 of 38,428 recalls
Recalled Item: da Vinci 5 mm Flared Instrument Cannulae for use with
The Issue: Intuitive Surgical is implementing a voluntary Field Action
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Versaport Bladeless Optical Trocar With Fixation Cannula - 5mm Product
The Issue: Seals may disengage from the cannula which may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Versaport Bladeless Optical Fixation Cannula - 5mm Product Code: ONBFCA5ST
The Issue: Seals may disengage from the cannula which may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Leucadia Autolok" Polyaxial Pedicle Screw System. Intended to help provide
The Issue: Alphatec Spine initiated this medical device recall for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NIPRO Safe Touch Safety Scalp Vein Set
The Issue: There is a possibility of a crack in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Large Tear Cross Cut Rasp 14mm x 7mm Ref. 5100-37-114
The Issue: The seal which maintains a sterile barrier for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: - Relieva Flex Sinus Guide Catheter (Green) Tip Shape: F-70
The Issue: The seal which maintains a sterile barrier for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: - CLEAR-TRAC COMPLETE
The Issue: The seal which maintains a sterile barrier for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: -Scorpion Needle
The Issue: The seal which maintains a sterile barrier for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: -Instratek Carpal Tunnel Release Blades
The Issue: The seal which maintains a sterile barrier for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: - Calf Garment Standard Ref. L501-M Lot 122549
The Issue: The seal which maintains a sterile barrier for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: - IDEAL 30 Suture Grasper (Green) 30 Degree Ref. 251721
The Issue: The seal which maintains a sterile barrier for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: - Re-New II Endocut Scissor Tip
The Issue: The seal which maintains a sterile barrier for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: -90 Degree L-Hook Tip Arthroscopic Electrode
The Issue: The seal which maintains a sterile barrier for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: - ACCU-PASS Suture Shuttle
The Issue: The seal which maintains a sterile barrier for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: - ENDOPATH Resposable Bladeless Trocar
The Issue: The seal which maintains a sterile barrier for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: - Abrader Bur
The Issue: The seal which maintains a sterile barrier for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TPS Micro Reciprocating Small Tear Cross Cut Rasp 5.0mm x
The Issue: The seal which maintains a sterile barrier for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: -ENDOPATH ETS-Flex Articulating Endoscopic Linear Cutter
The Issue: The seal which maintains a sterile barrier for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: - Turbosonics Mini-Flared ABS Tip
The Issue: The seal which maintains a sterile barrier for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.