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 7401–7420 of 38,428 recalls
Recalled Item: Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP)
The Issue: Users were reporting that the device was not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP)
The Issue: Users were reporting instances of "Gas Loss in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP)
The Issue: Users reported "System Over Temperature" alarms associated with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP)
The Issue: Users were reporting that the device was not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP)
The Issue: Users were identifying autofill failure conditions on the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP)
The Issue: Users were experiencing a failure in the IAB
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP)
The Issue: Users reported "System Over Temperature" alarms associated with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP)
The Issue: Users were reporting instances of "Gas Loss in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP)
The Issue: Users were identifying autofill failure conditions on the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP)
The Issue: Users were experiencing a failure in the IAB
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Guider Softip Guide Catheter 5F 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 8F 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 5F 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: Guider Softip Guide Catheter 6F 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 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: Guider Softip Guide Catheter 5F 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 7F 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 8F 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: Guider Softip Guide Catheter 8F 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 8F 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.