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 25801–25820 of 38,428 recalls
Recalled Item: Merge
The Issue: A product issues happens for RF projection images
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MEVION S250 Product Usage: Proton Radiation Therapy System
The Issue: Software defect:2D projection of contours in Verity. The
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Improve Blood Collection Sets with Multiple Sample Luer Adapter -
The Issue: Complaints about the needle is not smooth, with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Offset Reamer Handle
The Issue: On June 14, 2016, Greatbatch discovered a significant
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ultroid Hemorrhoid Management Systems 110/220 VAC and procedures kit including
The Issue: Products are not designed, qualified, manufactured, and/or managed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ultroid Procedure Pack including the Ultroid Sterile Disposable Probes.
The Issue: Products are not designed, qualified, manufactured, and/or managed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ultroid Mobile Generator/Battery operated unit including the Ultroid Sterile...
The Issue: Products are not designed, qualified, manufactured, and/or managed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ultroid Sterile Disposable Probes sold individually
The Issue: Products are not designed, qualified, manufactured, and/or managed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AQUIOS Lyse Reagent Kit
The Issue: Beckman Coulter is recalling the AQUIOS Lyse Reagent
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SOMATOM Definition Flash
The Issue: A problem can occur with the small light
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ADVIA Centaur CA 19-9 Assay (50 test kit)-for use
The Issue: CA 19-9 assay on the ADVIA Centaur CP
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ADVIA Centaur CA 19-9 Assay (250 test kit)-for use
The Issue: CA 19-9 assay on the ADVIA Centaur CP
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SOMATOM Definition AS
The Issue: A problem can occur with the small light
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SOMATOM Definition AS system
The Issue: Hardware issue that may expose the User to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SOMATOM Definition Flash system
The Issue: Hardware issue that may expose the user to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sheridan/CF
The Issue: Labeling inconsistency - units labeled with a 7mm
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ConforMIS iTotal Cruciate Retaining (CR) Knee Replacement System
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Xhibit Central Station
The Issue: The firm received reports of telemetry SpO2 numerics
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Combi Dockable Neurosurgery table for the Siemens MAGNETOM Aera (1.5T)
The Issue: Due to a potential manufacturing error, a rare
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Natus Warmette Blanket Cabinet and Warmette Dual Cabinet The Natus
The Issue: The fuse blows during initial power up or
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.