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 5541–5560 of 38,428 recalls
Recalled Item: RayStation 10.0.0.1154
The Issue: for reported SSD to be too high
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RayStation 10.1.0.613 and 10.1.1.54. Radiation Therapy Treatment Planning...
The Issue: for reported SSD to be too high
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Intellis AdaptiveStim Product Number 97715
The Issue: inability to reprogram one device
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RayStation 12.0.0.932
The Issue: for reported SSD to be too high
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RayStation 14.0.0.3338. 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 9.1.0.933 and 9.2.0.483. 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: NexGen CR-Flex Femoral Component
The Issue: Out of specification violation of devices that results
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Newport s N-LHP-928(j) units if sold as a laser head/power supply set
The Issue: According to 21 CFR 1040.10(f)(4), each laser system
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Jackson-Pratt 3-Spring Reservoir with Silicone Adapters
The Issue: Cardinal Health is issuing a lot number specific
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Jackson-Pratt 3-Spring Reservoir Kit with PVC Round Drain
The Issue: Cardinal Health is issuing a lot number specific
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Jackson-Pratt Universal Connector PVC Tubing Anti Transparent Y
The Issue: Cardinal Health is issuing a lot number specific
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Jackson-Pratt 3-Spring Reservoir Kit with PVC Round Drain
The Issue: Cardinal Health is issuing a lot number specific
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Jackson-Pratt 3-Spring Reservoir Kit with PVC Round Drain
The Issue: Cardinal Health is issuing a lot number specific
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BiPAP V30 Auto Ventilator
The Issue: for devices to experience interruption/loss of therapy
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BiPAP A40 Ventilators: BiPAP A40
The Issue: for devices to experience interruption/loss of therapy
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BiPAP A30 Ventilator
The Issue: for devices to experience interruption/loss of therapy
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stealth S8 Clinical Software Application
The Issue: Due to a software issue, there is the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: POLYSIN (Polyglycolic Acid) suture
The Issue: Complaints have been received with allegations of Incorrect
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hillrom Welch Allyn Connex ProBP 3400 Digital Blood Pressure Device
The Issue: Baxter received reports of an issue related to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Power Cords
The Issue: Baxter received reports of an issue related to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.