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 10501–10520 of 38,428 recalls
Recalled Item: Dynarex SWAB
The Issue: Facility Temperature excursions (from June 2021-August 2021) prior
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: a. Alcon Clear Care Contact Lens Solution Clear Care 12 oz. Solution
The Issue: Facility Temperature excursions (from June 2021-August 2021) prior
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EkoSonic Kit 106cm
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EkoSonic Kit 135cm
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Pressure Monitoring Set
The Issue: The products may contain excess coating material on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: t:slim X2 insulin pump
The Issue: Insulin pumps may have the following issues: 1)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Pyxis MedBank Cabinet Software v2.1.2.9 Legacy MedBank Cabinets with
The Issue: The automated dispensing cabinet software update included a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: t:slim X2 insulin pump
The Issue: Insulin pumps may have the following issues: 1)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Tibial Component Modular. orthopedic prosthesis. Model Nos: Small
The Issue: There is a risk that blind screws of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Endo Model Modular Rotational Tibia - Small (Model No #15-2814/02)
The Issue: There is a risk that blind screws of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Endo Model Modular Femur and Tibia
The Issue: There is a risk that blind screws of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Tibial Component. orthopedic prosthesis. Model Nos: Small
The Issue: There is a risk that blind screws of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Artis zeego (Model no. 10280959) and Artis Q.zeego (Model no. 10848283)
The Issue: It may occur that after system startup no
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CustMbite
The Issue: The device was marketed and sold in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MiniMed 640G Insulin Pump (O.U.S. Version)
The Issue: Due to battery cap deterioration, this may potentially
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MiniMed 740G Insulin Pump (O.U.S. Version)
The Issue: Due to battery cap deterioration, this may potentially
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MiniMed 670G Insulin Pump (U.S. and O.U.S. Version)
The Issue: Due to battery cap deterioration, this may potentially
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MiniMed 720G Insulin Pump (O.U.S. Version)
The Issue: Due to battery cap deterioration, this may potentially
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MiniMed 780G Insulin Pump (O.U.S. Version)
The Issue: Due to battery cap deterioration, this may potentially
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MiniMed 770G Insulin Pump (U.S. and O.U.S. Version)
The Issue: Due to battery cap deterioration, this may potentially
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.