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 24501–24520 of 38,428 recalls
Recalled Item: Dressing
The Issue: They may not have been sealed prior to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dressing Back
The Issue: They may not have been sealed prior to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RENOVATION
The Issue: The stability data does not support the product
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RENOVATION
The Issue: The stability data does not support the product
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dressing Shldr
The Issue: They may not have been sealed prior to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dressing Rect L
The Issue: They may not have been sealed prior to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RENOVATION
The Issue: The stability data does not support the product
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RENOVATION
The Issue: The stability data does not support the product
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RENOVATION
The Issue: The stability data does not support the product
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RENOVATION
The Issue: The stability data does not support the product
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RENOVATION
The Issue: The stability data does not support the product
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: If Hip
The Issue: They may not have been sealed prior to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Newport Medical HT70 and HT70- Plus Ventilators
The Issue: Medtronic is issuing a voluntary field corrective action
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RENOVATION
The Issue: The stability data does not support the product
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RENOVATION
The Issue: The stability data does not support the product
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RENOVATION
The Issue: The stability data does not support the product
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 18L6 HD transducer on the ACUSON S Family ultrasound systems
The Issue: When scanning with the 18L6 HD transducer on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medi-Therm Hyper/Hypothermia System
The Issue: The water may reheat too quickly if the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Arrow EZ-IO Needle Set 45 mm 15 ga
The Issue: Some of the individual unit packaging (pouches) may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Short Tip Rotational Intravascular Ultrasound (IVUS) Catheter
The Issue: High complaint rates of kinking near the junction
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.