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 8921–8940 of 38,428 recalls
Recalled Item: Luminos Agile with software VC10 - A diagnostic imaging system
The Issue: risk of collision with the ceiling, wall,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Luminos dRF with software VD10- A diagnostic imaging system for
The Issue: risk of collision with the ceiling, wall,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: cobas SARS-CoV-2 & Influenza A/B Qualitative nucleic acid test for
The Issue: The firm received customer complaints regarding false negative
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: cobas Influenza A/B & RSV UC (Utility Channel) Qualitative nucleic
The Issue: The firm received customer complaints regarding false negative
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: cobas SARS-CoV-2 & Influenza A/B Qualitative assay for use on
The Issue: The firm received customer complaints regarding false negative
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ultracell Wick with 80cc Collection Bag
The Issue: Device packaging may contain open seals, compromising product
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CustomEyes kits
The Issue: Device packaging may contain open seals, compromising product
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RELAY PRO
The Issue: The product may be shorter than packaging indicates
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RELAY PRO
The Issue: The product may be shorter than packaging indicates
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Scan Monitor/ScanWatch
The Issue: A software bug eliminated the initial ECG activation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Nuclear Medicine 600/800 series systems
The Issue: A mitigation may not be correctly implemented. If
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Nuclear Medicine 600/800 series systems
The Issue: A mitigation may not be correctly implemented. If
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Nuclear Medicine 600/800 series systems
The Issue: A mitigation may not be correctly implemented. If
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Nuclear Medicine 600/800 series systems
The Issue: A mitigation may not be correctly implemented. If
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Nuclear Medicine 600/800 series systems
The Issue: A mitigation may not be correctly implemented. If
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Nuclear Medicine 600/800 series systems
The Issue: A mitigation may not be correctly implemented. If
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP)
The Issue: The Cardiosave IABP may shut down unexpectedly due
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cardiosave Rescue Intra-Aortic Balloon Pump (IABP)
The Issue: The Cardiosave IABP may shut down unexpectedly due
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BIOSTOP G BIORESORBABLE CEMENT RESTRICTOR Catalog Numbers: 546308000 (Size 8)
The Issue: All lots of BIOSTOP G Bioresorbable Cement Restrictor
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Low Flow Disposable Patient Circuit for the Precision Flow System
The Issue: There have been reports of excessive condensation associated
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.