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 7701–7720 of 38,428 recalls
Recalled Item: MR 7700 Magnetic Resonance (MR) system
The Issue: The system operator is able to bypass the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ingenia Elition S Magnetic Resonance (MR) system
The Issue: The system operator is able to bypass the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ingenia Elition S Magnetic Resonance (MR) system
The Issue: During installation of the SmokeDetector Interlock, a connecting
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Azurion 7 M20. X-ray Image guided Therapy System.
The Issue: The bolts supporting the FlexMove Carriage may become
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Allura Xper FD10 and FD20. X-ray Imaging System.
The Issue: The bolts supporting the FlexMove Carriage may become
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Oxylog 3000 Plus emergency and transport ventilator
The Issue: Draeger has become aware of instances where the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Abbott Amplatzer Steerable Delivery Sheath (ASDS)
The Issue: There is an overall reported incidence rate of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: da Vinci Xi/X Tip-Up Fenestrated Grasper
The Issue: Fenestrated Graspers have a manufacturing issue has the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AEQUALIS FLEX REVIVE Assembly Screw 0mm Short
The Issue: A comingle/swap resulted in the labeling and laser
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AEQUALIS FLEX REVIVE Assembly Screw 0mm
The Issue: A comingle/swap resulted in the labeling and laser
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item:
The Issue: Sterility of Ultrasound gel can not be guaranteed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HF Resection Electrodes - HF resection electrodes are part of
The Issue: Additional Caution statements in IFU: (1) Due to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Argon Medical Devices
The Issue: There is the potential that the vena Cava
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Olympus BRONCHOFIBERSCOPE BF Type
The Issue: There have been complaints of endobronchial combustion during
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Olympus EVIS EXERA III BRONCHOVIDEOSCOPE BF TYPE
The Issue: There have been complaints of endobronchial combustion during
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Olympus BRONCHOVIDEOSCOPE
The Issue: There have been complaints of endobronchial combustion during
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Olympus EVIS EXERA BRONCHOVIDEOSCOPE BF TYPE
The Issue: There have been complaints of endobronchial combustion during
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Olympus OES BRONCHOFIBERSCOPE BF Type
The Issue: There have been complaints of endobronchial combustion during
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Olympus BRONCHOVIDEOSCOPE BF Type
The Issue: There have been complaints of endobronchial combustion during
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Olympus EVIS EXERA II BRONCHOVIDEOSCOPE BF TYPE
The Issue: There have been complaints of endobronchial combustion during
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.