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 7361–7380 of 38,428 recalls
Recalled Item: Prucka 3 Amplifiers
The Issue: A diode on the power supply of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Mallinckrodt One-Way Valve
The Issue: The One-Way Valve, 22F x 22M may stick
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Oculus Pentacam AXL
The Issue: Their is a potential that optical devices with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Oculus Myopia Master
The Issue: Their is a potential that optical devices with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Oculus Pentacam AXL Wave
The Issue: Their is a potential that optical devices with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Heartmate 3 LVAS Implant Kit
The Issue: Inability to start and/or complete the coring procedure
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: B.Braun NORM-JECT Luer Lock Solo
The Issue: The sterile blister packaging may be damaged, and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: B. Braun NORM-JECT Luer Solo
The Issue: The sterile blister packaging may be damaged, and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stryker ACM (Advanced Cement Mixing) System: ACM Kit w/ Femoral
The Issue: for the Break-Away Femoral Nozzle the applicator
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stryker ACM (Advanced Cement Mixing) System: Break-Away Femoral Nozzle-
The Issue: for the Break-Away Femoral Nozzle the applicator
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stryker ACM (Advanced Cement Mixing): 180-Gram Cement Cartridge with Breakaway
The Issue: for the Break-Away Femoral Nozzle the applicator
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stryker ACM (Advanced Cement Mixing)System: ACM Kit w/ Femoral Breakaway Nozzle
The Issue: for the Break-Away Femoral Nozzle the applicator
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stryker ACM (Advanced Cement Mixing)System: ACM Kit w/ Femoral Breakaway Nozzle
The Issue: for the Break-Away Femoral Nozzle the applicator
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stryker ACM (Advanced Cement Mixing) System: ACM Kit w/ Femoral
The Issue: for the Break-Away Femoral Nozzle the applicator
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stryker ACM (Advanced Cement Mixing) System: ACM Kit w/ Femoral
The Issue: for the Break-Away Femoral Nozzle the applicator
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS XT Chemistry Products ALKP Slides
The Issue: Samples containing high levels of ALKP (or an
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS XT Chemistry Products TBIL-ALKP Slides
The Issue: Samples containing high levels of ALKP (or an
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DJO Surgical: Empowr Knee
The Issue: Orthopedic device components were not subjected to final
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DJO Surgical: Delta Ceramic Femoral Head
The Issue: Orthopedic device components were not subjected to final
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DJO Surgical: CLP Hip
The Issue: Orthopedic device components were not subjected to final
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.