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 19661–19680 of 38,428 recalls
Recalled Item: Disposable 25GA Vitrectomy Cutter
The Issue: Packaging error, 20GA Vitrectomy Cutter may be found
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PerkinElmer QSight 210 MD Mass Spectrometer Simplicity 3Q MD v1.0
The Issue: Under certain conditions when using PerkinElmer QSight 210
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Xper Flex Cardio Physiomonitoring System
The Issue: The Invasive Blood Pressure (IBP) numeric values will
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Max Instrument
The Issue: A trend for false positive Candida glabrata results
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Max Instrument Reader Spare Part
The Issue: A trend for false positive Candida glabrata results
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Roche Diagnostics URISYS 1100 Urine Analyzer Part Number: 03617556001 Product
The Issue: Limits of Detection (LoD) for protein, nitrite, leukocytes,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SECURE EVA - DUAL CHAMBER CONTAINER With Screw Connectors
The Issue: for leaking product
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SECURE EVA - DUAL CHAMBER CONTAINER with Manifold
The Issue: for leaking product
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SECURE EVA - DUAL CHAMBER CONTAINER with Manifold
The Issue: for leaking product
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ExactaMix
The Issue: for leaking product
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SECURE EVA - DUAL CHAMBER CONTAINER With Screw Connectors
The Issue: for leaking product
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ExactaMix
The Issue: for leaking product
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SECURE EVA - DUAL CHAMBER CONTAINER with Manifold
The Issue: for leaking product
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SECURE EVA - DUAL CHAMBER CONTAINER With Screw Connectors
The Issue: for leaking product
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CORAIL AMT COXA VARA NECK SEGMENT (KLA) Pro. Code L20432
The Issue: There is the potential for debris/material to be
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CORAIL AMT STANDARD OFFSET NECK SEGMENT (STD)
The Issue: There is the potential for debris/material to be
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CORAIL AMT HIGH OFFSET NECK SEGMENT (KHO)
The Issue: There is the potential for debris/material to be
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Exprt Precision System: Revision Hip
The Issue: Complaints regarding loose proximal body bolts or bolts
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Arrow AGB+ Multi-Lumen CVC Kit
The Issue: The products labeling contains inconsistencies. In certain instances,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: StageOne Hip
The Issue: There is a potential for comingling of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.