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 11121–11140 of 38,428 recalls
Recalled Item: Arrow-Trerotola PTD Set (Percutaneous Thrombolytic Device)
The Issue: The firm received reports indicating PTD tip separation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Arrow-Trerotola PTD Set (Percutaneous Thrombolytic Device)
The Issue: The firm received reports indicating PTD tip separation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Arrow-Trerotola Over-The-Wire PTD Kit
The Issue: The firm received reports indicating PTD tip separation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Arrow-Trerotola Over-The-Wire PTD Kit
The Issue: The firm received reports indicating PTD tip separation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MODEL: X-RAY TV SYSSTEM SONIALVISION safire17
The Issue: It was found that the irradiated x-ray may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MODEL: X-RAY TV SYSTEM SONIALVISION G4
The Issue: It was found that the irradiated x-ray may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MODEL: X-RAY R/F SYSTEM FLUOROspeed X1
The Issue: It was found that the irradiated x-ray may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Thermo Scientific Sensititre Gram Negative Susceptibility Testing Plate
The Issue: There are lower than expected MICs for some
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RNAstill Molecular Transport Medium Vial
The Issue: The product does not have 510(k) clearance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Voyager Rollator-intended as a mechanical walker Model Number: RLEU10xx...
The Issue: Wheel spoke may crack causing the wheel to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing)
The Issue: Non-EUA authorized, CE marked, SARS-CoV-2 antigen rapid test
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Long
The Issue: Cleaning products, containing, but not limited to, hydrogen
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Baxter CAPD System Transfer Set (CAPD MiniCap Transfer Set II (34cm))
The Issue: Cleaning products, containing, but not limited to, hydrogen
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NavitrackER Kit A: Knee
The Issue: The product was released for distribution without passing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Comprehensive Shoulder System Primary Shoulder Stem
The Issue: The products in scope underwent an incorrect rework
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Arcos Modular Revision Hip System
The Issue: The products in scope underwent an incorrect rework
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Comprehensive Shoulder System Mini Humeral Stem
The Issue: The products in scope underwent an incorrect rework
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Comprehensive Shoulder System Mini Humeral Stem
The Issue: The products in scope underwent an incorrect rework
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Comprehensive Shoulder System Mini Humeral Stem
The Issue: The products in scope underwent an incorrect rework
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Comprehensive Shoulder System Primary Shoulder Stem
The Issue: The products in scope underwent an incorrect rework
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.