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 30961–30980 of 38,428 recalls
Recalled Item: da Vinci Xi Surgical System
The Issue: Correction due to a fault that causes distal
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The FLOW-i Anesthesia System Axillary O2 and Suction Module
The Issue: Maquet has identified that in some FLOW-i Anesthesia
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Steriseal-Cannula Ophthalmic
The Issue: The metal cannula attached to the handpiece can
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Master Drug Library Software version 8.0
The Issue: Loading/Bolus default dose settings in the Master Drug
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Lombart 90D Clear with case Visualization during diagnosis and laser
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Volk 25D Large Clear BIO Lens with case
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Kinemax Stem Extenders
The Issue: Stryker received four customer complaints reporting that inside
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare
The Issue: Specific Aespire 7900 Anesthesia Machines have an increased
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ENDOPATH ECHELON" Vascular White Reload for Advanced Placement Tip
The Issue: During an internal inspection of the production process
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CIVCO Surgi-Tip Transducer Cover Sterile (15.2 x 244 cm) polyethylene
The Issue: Leaks were detected in the recalled lot which
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ziploop Button Product Usage: The Ziploop Button is a non-resorbable
The Issue: The firm is recalling ToggleLocs and Ziploops manufactured
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vitagel
The Issue: Several shipments of Vitagel product (a surgical hemostat)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ToggleLoc
The Issue: The firm is recalling ToggleLocs and Ziploops manufactured
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LIS27T - Lacrimal Intubation Set RX Only Sterile Used in
The Issue: Expiration date incorrectly printed in Manufacturing Date field
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The Rheo Knee bionic prosthetic is to be used exclusively
The Issue: The firm is recalling Rheo Knee bionic prosthetic
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vitek 2 AST-P635 911 Gram Positive Susceptibility Card
The Issue: The outer carton label and package insert for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Amerigel Hydrogel Gauze Dressing 2 x 2
The Issue: Nonapproved labeling claims (Sterile)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Captiva's lumbar intervertebral fusion system Reamers (color code rings on
The Issue: It is possible for the titanium color-coded ring
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vitek 2 AST-P640 579 Gram Positive Susceptibility Card
The Issue: The outer carton label and package insert for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vitek 2 AST-P641 590 Gram Positive Susceptibility Card
The Issue: The outer carton label and package insert for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.