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 18841–18860 of 38,428 recalls
Recalled Item: Covidien Force TriVerse electrosurgical device 10 cord-Intended as...
The Issue: for the sterile packaging to be compromised
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PowerPort isp M.R.I. Implantable Port with Attachable 8F Polyurethane Open-Ended
The Issue: Complaints received that products packaged with the incorrect
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SOMATOM Definition AS with Option syngo DE Scan for Single
The Issue: risk of scans being aborted when using
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SOMATOM Confidence
The Issue: risk of scans being aborted when using
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SOMATOM Definition Edge
The Issue: risk of scans being aborted when using
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SOMATOM Edge Plus
The Issue: risk of scans being aborted when using
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Gentrix Surgical Matrix Thick
The Issue: The devices were released from a lot for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Gentrix Surgical Matrix Thick
The Issue: The devices were released from a lot for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BIOVENTUS Bioactive Bone Graft Putty 15g Rx only/sterile. Filler device
The Issue: The firm became aware of the potential for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Randox Blood Gas Control Level 2 -Model BG5002. In-vitro Diagnostic
The Issue: An error in the assignment of the control
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Discovery Ml DR Product Usage: The systems are intended for
The Issue: GE Healthcare PET/CT Table Stop Without Stopping X-Ray
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Discovery Ml Product Usage: The systems are intended for head
The Issue: GE Healthcare PET/CT Table Stop Without Stopping X-Ray
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Discovery PET/CT 610 Product Usage: The systems are intended for
The Issue: GE Healthcare PET/CT Table Stop Without Stopping X-Ray
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Optima PET/CT 560
The Issue: GE Healthcare PET/CT Table Stop Without Stopping X-Ray
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Discovery PET/CT 710 Product Usage: The systems are intended for
The Issue: GE Healthcare PET/CT Table Stop Without Stopping X-Ray
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Discovery IQ Product Usage: The systems are intended for head
The Issue: GE Healthcare PET/CT Table Stop Without Stopping X-Ray
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: e700 Automatic Transport Ventilator
The Issue: There is a potential for the unit to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: e600 Automatic Transport Ventilator
The Issue: There is a potential for the unit to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: e500 Automatic Transport Ventilator
The Issue: There is a potential for the unit to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Portex Blue Line Ultra Tracheostomy Tube Inner Cannula. One cannula
The Issue: Packaged with an incorrect size inner cannula
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.