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 10761–10780 of 38,428 recalls
Recalled Item: Convenience kits containing regard IV Start Kits: (1) regard Clinical
The Issue: A drug kit component was recalled by its
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ultrasonic Gastrovideoscope
The Issue: GF-UC140P-AL5 is no longer a compatible endoscope for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Convenience kits containing regard IV Start Kits: regard Clinical Packaging
The Issue: A drug kit component was recalled by its
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Convenience kits containing regard IV Start Kits: (1) regard Clinical
The Issue: A drug kit component was recalled by its
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Panther Fusion GBS Assay Cartridges 96 Tests
The Issue: Samples, run on a GBS Assay, that have
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: da Vinici X da Vinci Xi Sureform 45
The Issue: As a result of complaint data review, it
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LetsGetChecked Blood Sample Collection kit-In vitro diagnostic medical...
The Issue: Users received sample collection kits that were assigned
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ZEISS miLOOP Lens Fragmentation Device . Used during cataract
The Issue: High friction of the slider can cause the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MUSE Cardiology Information System
The Issue: Two scenarios may cause edits to measurements and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Separation Technology Creamatocrit Plus
The Issue: The device was being marketed as an IVD
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PrisMax System
The Issue: This correction is due to software anomalies occurring
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PrisMax System
The Issue: This correction is due to software anomalies occurring
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PrisMax System
The Issue: This correction is due to software anomalies occurring
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cardinal Health PROTEXIS PI and PI Classic
The Issue: Product was distributed without being sterilized
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CLARAVUE Pre-wired Electrode - IP SET M3 RT ADULT-US Model: 32028777 50600 US
The Issue: Instructions for Use (IFU) (Instructions for Use) indicate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CLARAVUE Pre-wired Electrode - IP SET 12 RT ADULT-US Model: 32028779 50602-US
The Issue: Instructions for Use (IFU) (Instructions for Use) indicate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CLARAVUE Pre-wired Electrode - IP SET 5V RT ADULT Model: 32028781 50604-US
The Issue: Instructions for Use (IFU) (Instructions for Use) indicate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CLARAVUE Pre-wired Electrode - IP SET M5 RT ADULT-US Model: 32028778 50601-US
The Issue: Instructions for Use (IFU) (Instructions for Use) indicate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CLARAVUE Pre-wired Electrode - IP SET 6V RT ADULT-US Model: 32028780 50603-US
The Issue: Instructions for Use (IFU) (Instructions for Use) indicate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CLARAVUE Pre-wired Electrode IP-SET N3 - PEDIATRIC-US Model: 32028776 50401-US
The Issue: Instructions for Use (IFU) (Instructions for Use) indicate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.