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 25601–25620 of 38,428 recalls
Recalled Item: SOMATOM Perspective
The Issue: Siemens is providing a new installation of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SOMATOM Scope
The Issue: Siemens is providing a new installation of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: K-Wire 1.4mm x 12in Non-Threaded
The Issue: The rods are packaged in packages with unacceptable
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Black Widow 6.6mm x 20mm Screw
The Issue: There is a problem with the mating feature
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Zeus-P Lumbar Interbody Device
The Issue: Labeling error where three boxes in inventory had
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dual Stylet Needle
The Issue: The rods are packaged in packages with unacceptable
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Optimus Fixed Awl
The Issue: Complaints that the tip of the awl broke
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Savannah-T Straight Rod
The Issue: The rods are packaged in packages with unacceptable
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AbbVie PEG Kit 20 FR
The Issue: AbbVie is issuing an urgent field correction notification
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RUSCH
The Issue: Labeling Inconsistency: The products have been labeled with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Black Widow Plate 19mm Plate
The Issue: There is a problem with the mating feature
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CyberKnife Robotic Radiosurgery System using software version 10.6
The Issue: Accuray has become aware of a potential safety
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CryoPatch SG Pulmonary Hemi-Artery Patch
The Issue: The device is recalled due to donor ineligibility
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Mallinckrodt Pharmaceuticals INOmax DSIR Plus delivery system. Model 10007....
The Issue: Mallinckrodt discovered that some devices may have been
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Carestream Touch Prime
The Issue: Software error; Carestream Health Inc, received a complaint
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GalaSHAPE 3D
The Issue: Endotoxin values from testing of retains slightly exceeded
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Prestige VH
The Issue: GE Healthcare is conducting a recall due to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Precision 500D
The Issue: GE Healthcare is conducting a recall due to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ADVANTX LCA
The Issue: GE Healthcare is conducting a recall due to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Prestige SI
The Issue: GE Healthcare is conducting a recall due to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.