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 29761–29780 of 38,428 recalls
Recalled Item: IPS Empress Universal Glaze Spray 270 mL
The Issue: Complaints were received of coarse particles in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medline Electrical Clipper with Charging base The Electrical Surgical Clipper
The Issue: Charging base of surgical clippers overheats and smokes
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Magic3 Hydrophilic-coated Female Intermittent Urinary Catheters (6")
The Issue: breach of the sterile barrier packaging
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Magic3 Hydrophilic-coated Female Intermittent Urinary Catheter 14 Fr in the
The Issue: breach of the sterile barrier packaging
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Magic3 Hydrophilic-coated Female Intermittent Urinary Catheters (6")
The Issue: breach of the sterile barrier packaging
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Magic3 Hydrophilic-coated Female Intermittent Urinary Catheters (6")
The Issue: breach of the sterile barrier packaging
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Magic3 Hydrophilic-coated Female Intermittent Urinary Catheters (6")
The Issue: breach of the sterile barrier packaging
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: S4C Occiput Torque Wrench F/Set Screw
The Issue: A FW103R torque wrench that was improperly reassembled
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RadiForce RX850
The Issue: EIZO is recalling the RadiForce LCD Monitors could
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RadiForce GX540
The Issue: EIZO is recalling the RadiForce LCD Monitors could
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RadiForce RX650
The Issue: EIZO is recalling the RadiForce LCD Monitors could
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SENSE Body Coil 1.5T with identification
The Issue: Wrong positioning of the coil cables can create
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Actuator for angiographic x-ray monitor ceiling suspension system. Actuator...
The Issue: The actuator assembly became detached and the monitor
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Syngo.plaza
The Issue: issue leading to data loss and patient
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Infant Heel Warmer and Infant Gel Warmer
The Issue: Product marketed without a 510(k)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: nordicICE v 2.3.14 nordicICE is an image processing software package
The Issue: The bug causes BOLD activation maps to be
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Spirit One A-C Powered Hospital Bed
The Issue: Inaccurate scale systems
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Spirit One A-C Powered Hospital Bed
The Issue: Customer complaints associated with faulty brake system
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 0.9% Sodium Chloride Injection
The Issue: Procedures for the acceptance and control of in-process
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Beacon Tip Royal Flush Plus High-Flow Catheter. Angiographic catheter. For
The Issue: Reports of catheter tip splits and or separation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.