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 25381–25400 of 38,428 recalls
Recalled Item: Cryptococcal Antigen Lateral Flow Assay (CrAg LFA)
The Issue: The affected products have approximately a 91% specificity
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OEC 9900 Elite. MDL Numbers: D148942
The Issue: GE Healthcare Surgery announces a voluntary field action
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AFX Endovascular AAA System
The Issue: Endologix updated the Instructions for Use (IFU) and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OEC 9800. MDL Numbers: D222250
The Issue: GE Healthcare Surgery announces a voluntary field action
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: cobas p 612 pre-analytical system Recalled by Roche Diagnostics Corporation...
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips Cisco 3850 layer 3 switch
The Issue: May experience a loss of centralized monitoring
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AFX Endovascular AAA System
The Issue: Endologix updated the Instructions for Use (IFU) and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AFX Endovascular AAA System
The Issue: Endologix updated the Instructions for Use (IFU) and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AFX Endovascular AAA System
The Issue: Endologix updated the Instructions for Use (IFU) and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AFX Endovascular AAA System
The Issue: Endologix initiated a correction by updating reports for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AFX Endovascular AAA System
The Issue: Endologix updated the Instructions for Use (IFU) and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD FlowSmart Set MiniMed Pro-set Rx Only Distributed by Medtronic
The Issue: Patients are reporting high blood glucose (HBG) levels
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CARDIOSAVE Hybrid IABP and CARDIOSAVE Rescue IABP affected part number
The Issue: Maquet has received 3 confirmed complaints related to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Maquet Express Dry Seal Suction OCEAN DRAIN
The Issue: Chest drains manual vent valve located at the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Maquet Ocean Water Seal Chest Drain
The Issue: Chest drains manual vent valve located at the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Maquet Oasis Dry Suction Water Seal Chest Drain
The Issue: Chest drains manual vent valve located at the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BrightView X upgraded to XCT 882454
The Issue: The intended use listed in the English and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Maquet Ocean Water Seal Chest Drain
The Issue: Chest drains manual vent valve located at the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Maquet Express Dry Seal Suction OASIS DRAIN
The Issue: Chest drains manual vent valve located at the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Maquet Express Dry Seal Suction OCEAN DRAIN
The Issue: Chest drains manual vent valve located at the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.