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 2061–2080 of 38,428 recalls
Recalled Item: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL
The Issue: Package labeling for Altivate Reverse Torx Peripheral screw
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CDI OneView System BPM Probe: Cat. No. CDI753 - CDI OneView BPM Probe
The Issue: Due to an error in assembly of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL
The Issue: Package labeling for Altivate Reverse Torx Peripheral screw
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL
The Issue: Package labeling for Altivate Reverse Torx Peripheral screw
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Long Nail
The Issue: Investigation confirmed that the GAMMA4 Right Long Nail
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Azurion R1.x and R2.x systems
The Issue: A software issue was identified in the internal
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: O-arm O2 Imaging System. Mobile X-Ray System.
The Issue: A mechanical component that supports the O2 gantry
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: KWIK-STICK
The Issue: Affected products were packaged with the incorrect KWIK
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Barco MNA with the HexaVue IP Integration System
The Issue: This is a sub-recall of event RES 96885
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SIGNA Architect
The Issue: GE HealthCare has become aware that gradient coils
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SIGNA Architect AIR
The Issue: GE HealthCare has become aware that gradient coils
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SIGNA PET/MR
The Issue: GE HealthCare has become aware that gradient coils
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Discovery MR750w 3.0T
The Issue: GE HealthCare has become aware that gradient coils
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Apex Knee System. Model Numbers: KC-50090
The Issue: Investigation has identified that the age of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medline convenience kits containing BD Insyte Autoguard Shielded IV Catheters
The Issue: Medline Industries, LP. is issuing a recall for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medline convenience kits containing BD Insyte Autoguard Shielded IV Catheters
The Issue: Medline Industries, LP. is issuing a recall for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medline convenience kits containing BD Insyte Autoguard Shielded IV Catheters
The Issue: Medline Industries, LP. is issuing a recall for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Jewel Precision Reusable Rigid Sterilization Container System. Model Number:...
The Issue: The 8-inch model of the Jewel Precision Reusable
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MicroMyst Applicator
The Issue: Lack of sterility assurance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Omnipod 5 Automated Insulin Delivery System
The Issue: Insulet Corporation is recalling Omnipod 5 iOS App,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.