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 37901–37920 of 38,428 recalls
Recalled Item: MCA5-06SD - 0.6MM Diamond Ball
The Issue: The Anspach Effort, Inc. is recalling all lots
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MCA7-05SD - 0.5MM Diamond Ball
The Issue: The Anspach Effort, Inc. is recalling all lots
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MCA7-2SD - 2MM Diamond Ball
The Issue: The Anspach Effort, Inc. is recalling all lots
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MCA5-05SD - 0.5 MM Diamond Ball
The Issue: The Anspach Effort, Inc. is recalling all lots
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MCA7-08SD - 0.8MM Diamond Ball
The Issue: The Anspach Effort, Inc. is recalling all lots
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MCA7-1SB - 1MM Fluted Ball
The Issue: The Anspach Effort, Inc. is recalling all lots
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MCA5-2SD - 2MM Diamond Ball
The Issue: The Anspach Effort, Inc. is recalling all lots
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MCA5-07SD - 0.7MM Diamond Ball
The Issue: The Anspach Effort, Inc. is recalling all lots
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MCA5-08SD - 0.8MM Diamond Ball
The Issue: The Anspach Effort, Inc. is recalling all lots
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MCA5-2SB - 2MM Fluted Ball
The Issue: The Anspach Effort, Inc. is recalling all lots
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MCA5-1SB - 1MM Fluted Ball
The Issue: The Anspach Effort, Inc. is recalling all lots
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Fresenius GranuFlo (powder) Acid Concentrate Product Codes: OFD1201-3B
The Issue: Risk of Alkalosis with acetate containing dialysis acid
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Fresenius NaturaLyte Liquid Acid Concentrate Product Codes: 08-0231-4
The Issue: Risk of Alkalosis with acetate containing dialysis acid
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Advanced Neuromodulation Systems
The Issue: Unintended Fluid ingress into the device header has
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Fast-Cath Transseptal Guiding Introducer
The Issue: St. Jude Medical is recalling a single batch
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MC-500 Multicolor Laser Photocoagulator
The Issue: The spot size control of the scan delivery
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PASCAL and PASCAL Streamline (532 nm.577 nm)
The Issue: When using the "Favorites" function for saved settings,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare
The Issue: GE Healthcare has become aware that when analyzing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CARDIOSAVE Intra-Aortic Balloon Pump An electromechanical system used to inflate
The Issue: In the Cardiosave Intra-aortic Balloon Pump, there is
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TANGO3 Water Storage Tank with Ozone Disinfection System
The Issue: During an FDA inspection, the firm was notified
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.