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 4041–4060 of 38,428 recalls
Recalled Item: Percussionaire
The Issue: Updated labeling to ensure that blue cap on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Atellica IM aTPO Assay
The Issue: Positive bias in patient results at and below
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Miami J Select Collar
The Issue: Pressure sensitive adhesive hooks attached to the sides
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Baxter EXACTAMIX Inlet
The Issue: Baxter Healthcare Corporation has received increased customer reports
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Baxter EXACTAMIX Inlet
The Issue: Baxter Healthcare Corporation has received increased customer reports
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Baxter EXACTAMIX Inlet
The Issue: Baxter Healthcare Corporation has received increased customer reports
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BinaxNOW Respiratory Strep A Test Kit
The Issue: Due to a classification error in our inventory
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Acceava Respiratory Strep A
The Issue: Due to a classification error in our inventory
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Baxter EXACTAMIX Inlet
The Issue: Baxter Healthcare Corporation has received increased customer reports
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: basixTOUCH Inflation Device
The Issue: Inflation devices may have a small hole in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Custom Inflation Kit
The Issue: Inflation devices may have a small hole in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: basixSKY Inflation Device
The Issue: Inflation devices may have a small hole in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MONARCH Inflation Device
The Issue: Inflation devices may have a small hole in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DiamondTOUCH Digital Inflation Device
The Issue: Inflation devices may have a small hole in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BlueFIRE Inflation Device
The Issue: Inflation devices may have a small hole in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Blue Diamond Digital Inflation Device
The Issue: Inflation devices may have a small hole in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: basixTOUCH Inflation Device
The Issue: Inflation devices may have a small hole in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: StabiliT TOUCH Syringe
The Issue: Inflation devices may have a small hole in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IntelliSystem Inflation Device
The Issue: Inflation devices may have a small hole in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Selenia Dimensions/ 3Dimensions-Digital breast tomosynthesis Software...
The Issue: Identified an issue with Selenia Dimensions 1.12.0 and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.