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 33601–33620 of 38,428 recalls
Recalled Item: SHAPE ARM
The Issue: During the use of the SHAPE Arm there
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SHAPE ARM
The Issue: During the use of the SHAPE Arm there
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BAM (SHAPE) ARM
The Issue: During the use of the SHAPE Arm there
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BAM (SHAPE) ARM
The Issue: During the use of the SHAPE Arm there
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SHAPE ARM
The Issue: During the use of the SHAPE Arm there
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Oxoid Legionella Latex Test
The Issue: A reagent contained within the product may return
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Digital Diagnost
The Issue: The footboard of Patient support for stitching can
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Oxoid Legionella Pneumo Groups 2-14
The Issue: A reagent contained within the product may return
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Smiths Medical HOTLINE¿ Fluid Warming Set L-80. Product Usage: intended
The Issue: Injection port of the Set may leak blood/
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Smiths Medical HOTLINE¿ Fluid Warming Set L-70. Product Usage: intended
The Issue: Injection port of the Set may leak blood/
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 3M" Steri-Vac" Gas Sterilizer/Aerators
The Issue: Recently, 3M received a single report of a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The Claymount Harmony is a grid cabinet designed to accept
The Issue: Harmony1 models of the Harmony Bucky is incorrectly
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The Claymount Harmony is a grid cabinet designed to accept
The Issue: Claymount Assemblies BV is recalling the Harmony2 model
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: InterValve V8 Balloon Aortic Valvuloplasty Catheter
The Issue: Leak issues were discovered through accelerated age testing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: K-Lite Knee 2 Stays with Visco
The Issue: Breg is recalling the Economy Elastic Knee Sleeve
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Economy Elastic Knee Sleeve Open
The Issue: Breg is recalling the Economy Elastic Knee Sleeve
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alcon LenSx Ophthalmic Laser
The Issue: Alcon LenSx received reports of unexpected downward motion
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic MiniMed Paradigm Insulin Infusion Pumps
The Issue: Medtronic is recalling the Medtronic MiniMed Paradigm Insulin
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 5X300 MM Curved Cannula
The Issue: Intuitive Surgical has become aware of the potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 5X250 MM Curved Cannula
The Issue: Intuitive Surgical has become aware of the potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.