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 7421–7440 of 38,428 recalls
Recalled Item: Guider Softip Guide Catheter 5F PRE-SHAPED 40 100CM
The Issue: Stryker Neurovascular has observed that certain lots of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Guider Softip Guide Catheter 7F 90CM MULTI PURPOSE
The Issue: Stryker Neurovascular has observed that certain lots of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Guider Softip Guide Catheter 6F 100CM MULTI PURPOSE
The Issue: Stryker Neurovascular has observed that certain lots of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Guider Softip Guide Catheter 7F PRE-SHAPED 40 100CM
The Issue: Stryker Neurovascular has observed that certain lots of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Guider Softip Guide Catheter 6F PRE-SHAPED 40 100CM
The Issue: Stryker Neurovascular has observed that certain lots of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Guider Softip Guide Catheter 7F PRE-SHAPED 40 90CM
The Issue: Stryker Neurovascular has observed that certain lots of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Henke-Ject-2 part luer sterile single use syringes - used for intravenous
The Issue: Sterile barrier might be damaged compromising the sterility
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Olympus Distal Attachment (in Olympus Disposable EMR Kit)- Designed to
The Issue: The Distal Attachment contain di-2-ethylhexyl phthalate (DEHP), which
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Reusable distal attachments Models: MH-462
The Issue: The Distal Attachment contain di-2-ethylhexyl phthalate (DEHP), which
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Olympus Bronchovideoscope
The Issue: Complaint of endoscope model becoming lodged in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Olympus Bronchovideoscope
The Issue: Complaint of endoscope model becoming lodged in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Olympus Tracheal Intubation Fiberscope
The Issue: Complaint of endoscope model becoming lodged in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Olympus Bronchovideoscope
The Issue: Complaint of endoscope model becoming lodged in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Olympus Bronchovideoscope
The Issue: Complaint of endoscope model becoming lodged in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Olympus Bronchovideoscope
The Issue: Complaint of endoscope model becoming lodged in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Olympus Airway Mobilescope
The Issue: Complaint of endoscope model becoming lodged in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Olympus Bronchovideoscope
The Issue: Complaint of endoscope model becoming lodged in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PASCAL Precision Transcatheter Valve Repair System
The Issue: Due to a manufacturing issue, when using valve
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Olympus Tracheal Intubation Fiberscope
The Issue: Complaint of endoscope model becoming lodged in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Olympus Bronchovideoscope
The Issue: Complaint of endoscope model becoming lodged in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.