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 22661–22680 of 38,428 recalls
Recalled Item: BC Thrombin Reagent Kit Lot Number 46751
The Issue: The BC Thrombin Reagent kit lot 46751 (contains
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Arrow Multi Lumen CVC Kit (Central venous catheter)
The Issue: These finished good kits may contain the incorrect
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Pressure Injectable Multi Lumen Central Venous Catheterization Kit with Blue
The Issue: These finished good kits may contain the incorrect
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ARROWg+ard Blue Plus Multi Lumen CVC (Central venous catheter)
The Issue: These finished good kits may contain the incorrect
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ARROWg+ard Blue Two Lumen Hemodialysis Catheterization Kit for High Volume
The Issue: These finished good kits may contain the incorrect
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Multi Lumen Central Venous Catheterization Kit
The Issue: These finished good kits may contain the incorrect
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Central Venous Catheterization Kit with Blue FlexTip Catheter
The Issue: These finished good kits may contain the incorrect
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Multi Lumen Central Venous Catheterization Kit with Blue FlexTip Catheter
The Issue: These finished good kits may contain the incorrect
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Pressure Injectable ARROWg+ard Blue PLUS Multi Lumen Central Venous...
The Issue: These finished good kits may contain the incorrect
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ARROW¿ PICC powered by ARROW¿ VPS¿ Stylet
The Issue: The kit may contain an incorrect catheter component
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Multi Lumen Central Venous Catheterization Kit with Blue FlexTip Catheter
The Issue: These finished good kits may contain the incorrect
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Pressure Injectable ARROWg+ard Blue PLUS Multi Lumen Central Venous...
The Issue: These finished good kits may contain the incorrect
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AGB+ Multi Lumen Central Venous Catheterization Kit
The Issue: These finished good kits may contain the incorrect
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Pressure Injectable ARROWg+ard Blue PLUS MultiLumen Central Venous...
The Issue: These finished good kits may contain the incorrect
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 3M Bair Hugger(TM) Normothermia System
The Issue: During a recent investigation, 3M confirmed that a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The Stryker Thoracic Pedicle Feeler 6002-350-000 is a smart instrument
The Issue: Stryker Instruments and Stryker Leibinger GmbH & Co
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: STAGE-1¿ RDS COC Abutment Plastic Sleeve
The Issue: A locking plastic abutment sleeve, used by dental
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medivance ArcticGel Small Pad Kit - a box containing a single foil pouch
The Issue: Hydrogel peeling from the pads
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Remisol Advance Software (Driver Architect) Catalog Number B32129 The Remisol
The Issue: Beckman Coulter has identified that due to a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Fukuda Denshi patient monitor model DS-8100M and DS-8100N Product Usage:
The Issue: For the Fukuda Denshi patient monitor model DS-8100,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.