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 12221–12240 of 38,428 recalls
Recalled Item: Simpleware ScanIP software. For transfer of imaging information from a
The Issue: A issue (bug) has been identified with the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Simpleware ScanIP medical software. For transfer of imaging information from
The Issue: A issue (bug) has been identified with the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Spectrum IQ Infusion System with Dose IQ Safety Software
The Issue: System errors were noted following changes the customers
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Recirculator 8.0s Disposable Lavage Kit (product code number 8100)
The Issue: The patient may be exposed to potential aluminum
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SIGNA Premier - Product Usage: is a whole body magnetic
The Issue: GE Healthcare has recently become aware of an
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SIGNA Artist
The Issue: GE Healthcare has recently become aware of an
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SIGNA PET/MR
The Issue: GE Healthcare has recently become aware of an
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Discovery MR750w 3.0T - Product Usage: is a whole body
The Issue: GE Healthcare has recently become aware of an
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 1.5T SIGNA HDxt (HD28) MR System
The Issue: GE Healthcare has recently become aware of an
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Discovery MR450 1.5T
The Issue: GE Healthcare has recently become aware of an
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SIGNA MR380
The Issue: GE Healthcare has recently become aware of an
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SIGNA MR355
The Issue: GE Healthcare has recently become aware of an
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Optima MR450w 1.5T
The Issue: GE Healthcare has recently become aware of an
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Discovery MR750 3.0T - Product Usage: is a whole body
The Issue: GE Healthcare has recently become aware of an
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SIGNA Creator
The Issue: GE Healthcare has recently become aware of an
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SIGNA Architect - Product Usage: is a whole body magnetic
The Issue: GE Healthcare has recently become aware of an
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SIGNA Pioneer - Product Usage: is a whole body magnetic
The Issue: GE Healthcare has recently become aware of an
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SIGNA Voyager
The Issue: GE Healthcare has recently become aware of an
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HeartWare HVAD Driveline Extension Cable
The Issue: Medtronic is stopping the distribution and sale of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ECHELON FLEX Powered Plus Stapler-intended for transection
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.