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 33521–33540 of 38,428 recalls
Recalled Item: Alligator Retrieval Device (ARD). Used in the peripheral and neurovasculature
The Issue: for the PTFE (polytetrafluoroethylene) coating to delaminate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Pipeline Embolization Device (PED). Used endovascular treatment of adults with
The Issue: for the PTFE (polytetrafluoroethylene) coating to delaminate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EZ-IO 45mm (40kg & up) Needle Set
The Issue: The voluntary recall is due to the needle
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Boston Scientific
The Issue: Neo Metrics, Inc. is recalling NovaGold Guidewire because
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips HeartStart XL+ Defibrillator/Monitor Model number: 861290
The Issue: A component on the HeartStart XL+ Therapy Board
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The OEC 9900 Elite mobile fluoroscopy system (image intensified fluoroscopic
The Issue: GE Healthcare has identified a potential safety issue
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Henora 300psi I.V. Catheter Extension Set Product Usage:
The Issue: Problem with low adhesion of the tubing to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Integra Newdeal SURFIX Fixed Angle Locking Screw 3.5mm x 22mm
The Issue: New Deal has identified through a complaint report
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Terumo Cardiovascular Procedure Kit- X-Coated Pump and Table Pack with
The Issue: Incorrect customer notification label applied to the Tyvek
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GLOBAL¿ Anchor Peg Glenoid Plus (APG+) 2.5MM Breakaway Guide Pin
The Issue: Urgent Device Correction notifications are being sent to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Proteus 235 Proton Therapy System for cancer treatment.
The Issue: While the Proteus 235 is in the pencil
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: INOmax DSIR
The Issue: An anomaly impacts the monitoring system of INOmax
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Vivid E9 Ultrasound System
The Issue: GE Healthcare has recently become aware of a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Brilliance CT 16
The Issue: Block assembly-lock stop subframe of service latch was
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sit/stand Rolling Walker
The Issue: Harbor Freight Tools intiaited a recall of Sit/Stand
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The Osteo-Clage System consists of stainless steel cable/sleeves and compression
The Issue: Manufacturing of these devices with a grade of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS Chemistry Products Specialty Diluent
The Issue: Ortho Clinical Diagnostics (OCD) confirmed the potential for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The Acumed Tension Band Pin is a fixation pin which
The Issue: Certain lots of Acumed Tension Band Pins are
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS Chemistry Products FS Diluent Pack 3
The Issue: Ortho Clinical Diagnostics (OCD) confirmed the potential for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ToxCup Drug Screen Cup
The Issue: May be labeled with incorrect result interpretation graphics
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.