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 25741–25760 of 38,428 recalls
Recalled Item: CADD Solis VIP Ambulatory Infusion Pump
The Issue: 20 Pumps sold to the Finnish market contain
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HOTLINE Blood and Fluid Warmer
The Issue: HOTLINE Blood and Fluid Warmers included Greek and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ConFORMIS ITOTAL PS-IPOLYIMPLANT KIT-RIGHT Catalog Number:TPS-111-1111 The...
The Issue: iView report displayed femoral cut measurements in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medi Choice Arm Slings ASL 2103 Small 7.5 x 12.5 Inch 1/EA
The Issue: Owens & Minor is the initial importer and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Perceval Sutureless Aortic Heart Valve size S
The Issue: Sorin Group USA, Inc. announces a voluntary field
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MSS CASSETTE GLU/LAC/UREA (BUN) as a part of the Roche
The Issue: Incorrect Urea results may be generated sporadically on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Bridge Occlusion Balloon. Model: 590-001 Temporary vessel occlusion of the
The Issue: Spectranetics Corporation announces a voluntary field action for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Turbo Elite Atherectomy Catheter. Models: 410-152
The Issue: Spectranetics Corporation announces a voluntary field action for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ELCA Coronary Atherectomy Catheter. Models: 110-001
The Issue: Spectranetics Corporation announces a voluntary field action for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Synthes Flexible Shaft
The Issue: Non-conforming material used
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MEVION S250 Product Usage: Proton Radiation Therapy
The Issue: Completing Setup Without Program Move Complete Can Cause
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 12C (AdaPTinsight) Affected component: AdaPTinsight software Product Usage:...
The Issue: IBA is initiating this recall to address an
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Freelite Human Lambda Free Kit for use on SPAPLUS Product Code: LK018.S
The Issue: A change in the calibration curve causing an
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Gomco Circumcision Clamps with separate O-Ring Component: The device is
The Issue: Aesculap has received complaints of excessive bleeding after
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Natus neoBLUE blanket LED Phototherapy system
The Issue: neoBLUE blanket LED Phototherapy System distributed since release
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Rochester-Pean Hemostatic Forceps 61/4
The Issue: The Chevron seals of 6x10 Tyvek peel pouch
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Metzenbaum Scissors 7
The Issue: The Chevron seals of 6x10 Tyvek peel pouch
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SURESOUND22US Multipack (US Distribution) containing 2 packs of six devices.
The Issue: Breach in sterile barrier compromising product sterility
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Femoral and Tibial Cutting Block Adapter Base. Brainlab knee
The Issue: Brainlab Knee Navigation System: Femoral and Tibial Cutting
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Mucosal Atomization Device (MAD)
The Issue: Product Defect; These products may produce a straight
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.