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 7121–7140 of 38,428 recalls
Recalled Item: SPRYSTEP VECTOR
The Issue: Due to potential air pockets between layers of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DBX Demineralized Bone Matrix Putty 10cc-Indicated for treatment of surgically
The Issue: Units are labeled as 10cc; however the units
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Olympus High-Flow Insufflation Unit
The Issue: There have been reports of patients suffering arrhythmias,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Regard CV PK
The Issue: Specific Regard kits contain the Gentige Chest Drain
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Atrium Advanta V12 Covered Stent System
The Issue: Balloon-to-catheter weld failure that may cause loss of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DigitalDiagnost 4 Chest/Emergency
The Issue: for units suspended on the ceiling to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CombiDiagnost R90
The Issue: for units suspended on the ceiling to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DigitalDiagnost 4 High Performance
The Issue: for units suspended on the ceiling to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DigitalDiagnost C90 Release 3
The Issue: for units suspended on the ceiling to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DigitalDiagnost C90 Release 3.1
The Issue: for units suspended on the ceiling to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ProxiDiagnost N90
The Issue: for units suspended on the ceiling to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DigitalDiagnost C90 High Performance
The Issue: for units suspended on the ceiling to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DigitalDiagnost C90 Flex/Value/Chest/ER
The Issue: for units suspended on the ceiling to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EasyDiagnost Eleva DRF
The Issue: for units suspended on the ceiling to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DigitalDiagnost 4 Flex/Value
The Issue: for units suspended on the ceiling to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 8713051U
The Issue: Upstream occlusion alarm may sound when no occlusion
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 8713052U
The Issue: Upstream occlusion alarm may sound when no occlusion
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TruDi Navigation System
The Issue: When using affected curette and software, there is
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Monoject 1 mL Tuberculin Syringe Luer-Lock Tip Soft Pack
The Issue: Demonstrated recognition and compatibility issues with syringe infusion
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Monoject 20 mL Syringe Luer-Lock Tip Soft Pack
The Issue: Demonstrated recognition and compatibility issues with syringe infusion
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.