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 13521–13540 of 38,428 recalls
Recalled Item: SenTec Digital Monitor
The Issue: Device requires the use of an Isolation Transformer
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare Precision 600FP
The Issue: GE Healthcare has become aware of a potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Argon Medical Devices TLAB
The Issue: Due to a manufacturing error their is a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Argon Medical Devices TLAB
The Issue: Due to a manufacturing error their is a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Argon Medical Devices TLAB
The Issue: Due to a manufacturing error their is a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Argon Medical Devices TLAB
The Issue: Due to a manufacturing error their is a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Argon Medical Devices TLAB
The Issue: Due to a manufacturing error their is a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Argon Medical Devices TLAB
The Issue: Due to a manufacturing error their is a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE NM/CT 870 CZT system Model Number H3906CW - Product
The Issue: GE Healthcare has become aware that rotor bearing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Discovery NM 630 (Model Number H3101RH)
The Issue: GE Healthcare has become aware that rotor bearing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Discovery 670 DR (Model H3100BT)
The Issue: GE Healthcare has become aware that rotor bearing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE NM/CT 850 system Model Number H3907AD - Product Usage:
The Issue: GE Healthcare has become aware that rotor bearing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE NM/CT 860 system Model Number H3908AD - Product Usage:
The Issue: GE Healthcare has become aware that rotor bearing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Remel Blood Agar/MacConkey Agar Bi-Plate
The Issue: The blood agar side of the bi-plate may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Optima NM/CT 640
The Issue: GE Healthcare has become aware that rotor bearing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Clerio Vision
The Issue: One lot of contact lenses labeled as BC
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TomoTherapy Treatment Delivery System with iDMS - Product Usage: used
The Issue: "MLC tickle error" may result in the delivered
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TomoTherapy Treatment System - Product Usage: used as an integrated
The Issue: "MLC tickle error" may result in the delivered
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Covidien CV-9590 Velosorb Fast Braided Fast absorbable Suture 14 Metric
The Issue: Due to a manufacturing error, there is a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Regional Block Needles 22G x 1.50in (50 units/cs.). Indicated
The Issue: BD was advised by the European Notified Body,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.