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 701–720 of 38,428 recalls
Recalled Item: IntelliVue MP90. Product Number: M8010A.
The Issue: issue where the IntelliVue monitors did not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IntelliVue MP30. Product Number: M8002A.
The Issue: issue where the IntelliVue monitors did not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IntelliVue Patient Monitor MX800. Product Number: 865240.
The Issue: issue where the IntelliVue monitors did not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Lumify Diagnostic Ultrasound System models : 795005
The Issue: Ultrasound system compatibility issues with Apple devices running
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IntelliVue Patient Monitor MX700. Product Number: 865241.
The Issue: issue where the IntelliVue monitors did not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IntelliVue Patient Monitor MX500. Product Number: 866064.
The Issue: issue where the IntelliVue monitors did not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IntelliVue Patient Monitor MX850. Product Number: 866470.
The Issue: issue where the IntelliVue monitors did not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IntelliVue MP2. Product Number: M8102A.
The Issue: issue where the IntelliVue monitors did not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IntelliVue MP50. Product Number: M8004A.
The Issue: issue where the IntelliVue monitors did not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IntelliVue MP80. Product Number: M8008A.
The Issue: issue where the IntelliVue monitors did not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IntelliVue Patient Monitor MX100. Product Number: 867033.
The Issue: issue where the IntelliVue monitors did not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IntelliVue MP40. Product Number: M8003A.
The Issue: issue where the IntelliVue monitors did not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Olympus OER-Elite
The Issue: Inform existing affected device customers about pertinent Warnings/Cautions,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IntelliVue Multi Measurement Server X2. Product Number: M3002A.
The Issue: issue where the IntelliVue monitors did not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IntelliVue MP60. Product Number: M8005A.
The Issue: issue where the IntelliVue monitors did not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IntelliVue MP5. Product Number: M8105A.
The Issue: issue where the IntelliVue monitors did not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IntelliVue MP20. Product Number: M8001A.
The Issue: issue where the IntelliVue monitors did not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IntelliVue Patient Monitor MX600. Product Number: 865242.
The Issue: issue where the IntelliVue monitors did not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IntelliVue Patient Monitor MX400. Product Number: 866060.
The Issue: issue where the IntelliVue monitors did not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IntelliVue Multi-Measurement Module X3. Product Number: 867030.
The Issue: issue where the IntelliVue monitors did not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.