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 19801–19820 of 38,428 recalls
Recalled Item: CyPass ULTRA SYSTEM
The Issue: Analysis of the completed dataset from the COMPASS-XT
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CyPass System 241
The Issue: Analysis of the completed dataset from the COMPASS-XT
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Heart Ware(TM) HVAD(TM) System Controller/Controller Kits
The Issue: Certain HVAD System Controller units may not meet
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Terumo 220/240V AC
The Issue: Screws on a Terumo¿ Advanced Perfusion System 1
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Terumo 100/120V AC
The Issue: Screws on a Terumo¿ Advanced Perfusion System 1
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VidiStar(TM) PACS & DICOM Viewer Software system
The Issue: The secure filesystem client software used in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Li-ion Battery Housing for AR-400 DrillSaw Sports 400 System Product
The Issue: The Li-ion Battery Housing for the AR-400 DrillSaw
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Beckman Coulter Lipase
The Issue: NAPQI, a metabolite of Acetaminophen, causes negative interference
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Beckman Coulter Uric Acid
The Issue: NAPQI, a metabolite of Acetominophen, causes negative interference
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TriMed Dorsal Wrist Hook Plate
The Issue: Modifications to the specification were not appropriately qualified
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TriMed Hex Cortical Screw 4.0
The Issue: The bone screw is shorter than the intended
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FlexLab (FLX)
The Issue: The firm has identified customer sites where there
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Gibco MEM Non-Essential Amino Acids Solution (100X) (SKU 11140050)
The Issue: Leaky bottles due to a defect in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Gibco GlutaMAX Supplement
The Issue: Leaky bottles due to a defect in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Gibco DPBS
The Issue: Leaky bottles due to a defect in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Gibco Sodium Pyruvate (100 mM) SKU 11360070
The Issue: Leaky bottles due to a defect in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Integrated Gate Controller PCB (component of AlignRT Plus) Truebeam variant
The Issue: RTInterface error in the event of an I/O
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Disposable Insulin Syringe 0.3mL in 3 different sizes 29Gx1/2
The Issue: Defect consists of a small crack in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AIA-360 Analyzer
The Issue: The firm has implemented new product labeling changes
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stryker Sustainability Solutions LASSO NAV eco Reprocessed Diagnostic EP...
The Issue: Electrophysiology catheters were identified to be item #
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.