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 5521–5540 of 38,428 recalls
Recalled Item: The Distal Access Catheter is a single-lumen
The Issue: Stryker Neurovascular is recalling their DAC- Distal Access
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dako CoverStainer
The Issue: There is the potential for the front plexiglass
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sterile CoFlex NL: Latex Free Flexible Cohesive Bandage
The Issue: A packaging seal gap could impact the sterility
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Airvo 2 Humidifier
The Issue: Humidifier devices, used to deliver high flow respiratory
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OmniLab Advanced + Ventilator Product Numbers 1111122 1111123 1111124 1111125
The Issue: Device may experience an interruption or loss of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EchoTip¿ Ultra HD Endoscopic Ultrasound Access Needle
The Issue: Devices may contain elevated levels of bacterial endotoxin
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LASER Application Instrument
The Issue: Laser surgical instruments have no specific evidence of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EchoTip¿ Ultra Endoscopic Ultrasound Access Needle
The Issue: Devices may contain elevated levels of bacterial endotoxin
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LOSPA Tibial Insert Model/Catalog Number: See below Software Version: N/A
The Issue: Due to unsupported 10 year expiration date
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LOSPA Patella Component Model/Catalog Number: 01.10.9XX Software Version:...
The Issue: Due to unsupported 10 year expiration date
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The Oncology Essentials Package of the Spectral CT imaging system.
The Issue: for third party oncology marking laser to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stryker 1
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HORIBA custom configured fluorescence instrument
The Issue: HORIBA custom configured fluorescence instrument has a laser
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RayStation 13.0.0.1547
The Issue: for reported SSD to be too high
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RayStation 8.1.0.47
The Issue: for reported SSD to be too high
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RayStation 9.0.0.113 and 9.0.1.142. Radiation Therapy Treatment Planning System.
The Issue: for reported SSD to be too high
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RayStation 11.0.0.951
The Issue: for reported SSD to be too high
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RayStation 8.0.0.61
The Issue: for reported SSD to be too high
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RayStation 15.0.0.430. Radiation Therapy Treatment Planning System.
The Issue: for reported SSD to be too high
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RayStation 7.0.0.19. Radiation Therapy Treatment Planning System.
The Issue: for reported SSD to be too high
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.