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 2141–2160 of 38,428 recalls
Recalled Item: Product Name: Ingenia 1.5T S
The Issue: for alignment errors in the cross reference
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Product Name: SmartPath to dStream for 3.0T
The Issue: for alignment errors in the cross reference
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Product Name: Ingenia Ambition X
The Issue: for alignment errors in the cross reference
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Product Name: Ingenia Elition S
The Issue: for alignment errors in the cross reference
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Product Name: SmartPath to Ingenia Elition X
The Issue: for alignment errors in the cross reference
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Product Name: Ingenia Ambition S
The Issue: for alignment errors in the cross reference
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Product Name: Evolution Upgrade 1.5T
The Issue: for alignment errors in the cross reference
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Product Name: SmartPath to dStream for XR and 3.0T
The Issue: for alignment errors in the cross reference
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Product Name: SmartPath to dStream for 1.5T
The Issue: for alignment errors in the cross reference
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Product Name: MR 5300
The Issue: for alignment errors in the cross reference
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Product Name: Ingenia 1.5T
The Issue: for alignment errors in the cross reference
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Product Name: Upgrade to MR 7700
The Issue: for alignment errors in the cross reference
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The HemoCue Glucose 201 Microcuvettes are designed for use with
The Issue: Glucose microcuvettes experienced transit time outside of limits,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dexcom One+ Continuous Glucose Monitoring System
The Issue: Defective foam or an assembly error may cause
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dexcom One Continuous Glucose Monitoring System
The Issue: Defective foam or an assembly error may cause
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dexcom G6 Glucose Receiver
The Issue: Defective foam or an assembly error may cause
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dexcom G7 Glucose Receiver
The Issue: Defective foam or an assembly error may cause
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IVENIX INFUSION SYSTEM LVP Blood Products Administration Set
The Issue: Mis-assembly error of Blood Products Administrations Sets where
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD TEXIUM CLOSED MALE LUER WITH FEMALE CAP
The Issue: Sterile, single use closed system drug transfer devices,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Texium Needle-Free Syringe: 3 mL
The Issue: Sterile, single use closed system drug transfer devices,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.