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 25941–25960 of 38,428 recalls
Recalled Item: 7.2cm Adjustable Drill Guide Product Usage: Electric system
The Issue: Supplied Directions for Use (DFU) did not contain
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: B-SAGITTAL ASSEMBLY Product Usage: Pneumatic system
The Issue: Supplied Directions for Use (DFU) did not contain
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Minimal Access Straight Driver Product Usage: Pneumatic system
The Issue: Supplied Directions for Use (DFU) did not contain
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SMALL ATTACHMENT
The Issue: Supplied Directions for Use (DFU) did not contain
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Chuck Driver System
The Issue: Supplied Directions for Use (DFU) did not contain
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Console
The Issue: Supplied Directions for Use (DFU) did not contain
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 19CM ATTACHMENT
The Issue: Supplied Directions for Use (DFU) did not contain
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sagittal Saw Product Usage: Pneumatic system
The Issue: Supplied Directions for Use (DFU) did not contain
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Minimal Access Attachment
The Issue: Supplied Directions for Use (DFU) did not contain
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Minimal Access Attachment Product Usage: Pneumatic system
The Issue: Supplied Directions for Use (DFU) did not contain
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 16cm Minimally Invasive Attachment Product Usage: Pneumatic system
The Issue: Supplied Directions for Use (DFU) did not contain
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Bearing Sleeve
The Issue: Supplied Directions for Use (DFU) did not contain
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 6.5CM ADLT CRANI
The Issue: Supplied Directions for Use (DFU) did not contain
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Otologic Curved Micro Product Usage: Pneumatic system
The Issue: Supplied Directions for Use (DFU) did not contain
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 8.0cm Medium Attachment Product Usage: Pneumatic system
The Issue: Supplied Directions for Use (DFU) did not contain
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IMRI SHORT HD ATTACHMENT Product Usage: Pneumatic system
The Issue: Supplied Directions for Use (DFU) did not contain
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 5.9CM ATTACHMENT
The Issue: Supplied Directions for Use (DFU) did not contain
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AL-III W/ male disconnect and 20ft hose Product Usage: Pneumatic system
The Issue: Supplied Directions for Use (DFU) did not contain
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Bearing Sleeve
The Issue: Supplied Directions for Use (DFU) did not contain
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PEDIATRIC CRANIOTOME
The Issue: Supplied Directions for Use (DFU) did not contain
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.