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 30981–31000 of 38,428 recalls
Recalled Item: Various Lots of Expel Drainage Catheter with TwistLoc Hub Biliary
The Issue: Complaints of device fragmentation after the catheter was
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Boston Scientific: Expel" Drainage Catheter with Twist-Loc" Hub APDL Drainage
The Issue: Boston Scientific is initiating this Medical Device Field
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LASSO NAV Duo Loop eco Catheters
The Issue: Biosense Webster is recalling the LASSO NAV Duo
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: QuikLYTE Dilution Check: used to monitor and adjust for the
The Issue: A positive bias beyond 5% resulting in a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Synthes 130 Degree Aiming Arm and 125 Degree Aiming Arm
The Issue: The guide sleeve has the potential to jam
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Skintact ECG Electrode FS-50
The Issue: The electrodes may fail to transmit signals
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LeMaitre Vascular Tumescent Catheter Inversion (TCI) System. The TCI System
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Mobius3D Product Usage: Mobius3D software is used for quality assurance
The Issue: Mobius3D version 1.5.0 contained a defect in software
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RECLAIM Assembled Implant Inserter Adaptor orthopedic manual surgical...
The Issue: This lot of the RECLAIM Assembled Implant Inserter
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic
The Issue: Clinicians observed debris, appearing to originate from the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Catalys Precision Laser System-Catalys - U - US product
The Issue: Software anomaly on OptiMedica CATALYS System version 3.00.05
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 2008 Series Hemodialysis Machines: 2008K with the following product code
The Issue: The Acetate value for GranuFlo on the Select
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 2008 Series Hemodialysis Machines: 2008K2 with the following product code
The Issue: The Acetate value for GranuFlo on the Select
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 2008 Series Hemodialysis Machines: 2008T with the following product code
The Issue: The Acetate value for GranuFlo on the Select
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 2008 Series Hemodialysis Machines: 2008Kathome - 190895 2008T GEN 2
The Issue: The Acetate value for GranuFlo on the Select
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OptiMedica Catalys Precision Laser System
The Issue: Device may experience loss of suction during treatment
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GAP Nail 4.8mm (diameter size) of the GAP ENDO-EXO MEDULLARY
The Issue: Failures of the 4.8mm of the GAP Endo-Exo
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Endo TCS Driver Straight Hexalobe #6 P/N 5210-1004
The Issue: The TCS Straight Hexlobular #6 Drivers (5210-1004) tip
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Coblator II System
The Issue: The recalling firm was notified by the contract
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Caviwave Pro Ultrasonic Cleaning System
The Issue: Should the Caviwave Pro Ultrasonic Cleaning System experience
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.