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 10981–11000 of 38,428 recalls
Recalled Item: VERIGENE Nucleic Acid Test Kit-BC-GN Extraction Tray - 9.73 mL
The Issue: Higher than normal "No Call Internal Control failures"
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Revogene
The Issue: The photomultiplier tube, may have compromised functionality in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Wright Medical Technology
The Issue: An incorrect screw is packaged in the product,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ProteusPLUS and ProteusONE- designed to produce and deliver a proton
The Issue: When resuming from a beam pause, the Proton
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Evita V500 Ventilator with Software 2.51.01 and Lower - intended
The Issue: Cybersecurity Improvement Action-not equipped against potential cyber security
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach
The Issue: IFU update includes an update to the Device
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cook Celect PlatinumVena Cava Filter Set Catalog Number/GPN:...
The Issue: IFU update includes an update to the Device
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Babylog VN500 Ventilator with Software 2.51.01 and Lower- intended for
The Issue: Cybersecurity Improvement Action-not equipped against potential cyber security
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cytocell 8 Square Template Slides (Glass)- microscope slides : PCN008
The Issue: Labelled with an incorrect expiry date on the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Compella Therapy Air Supply Unit
The Issue: damage to the power cord may cause
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BIOMET TRAUMA A.L.P.S. FIBULA COMPOSITE LOCKING PLATE 8 HOLE
The Issue: Packaging of various implants may not have sufficient
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BIOMET Sports Medicine JUGGERLOC SLOTTED REAMER: [Item # 110010371
The Issue: Packaging of various implants may not have sufficient
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BIOMET TRAUMA Drill Bit
The Issue: Packaging of various implants may not have sufficient
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BIOMET Trauma
The Issue: Packaging of various implants may not have sufficient
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Compella Bariatric Bed System
The Issue: damage to the power cord may cause
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CombiDiagnost R90 1.1 (709031)
The Issue: While performing a fluoroscopy examination, there is a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CombiDiagnost R90 1.0 (709030)
The Issue: While performing a fluoroscopy examination, there is a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HUNTLEIGH Disposable intraoperative Probe
The Issue: Faceplate may become detached from the probe body
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RayStation 4-11B
The Issue: Incorrect source to skin or surface distance (SSD)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alinity m Integrated Reaction Units (IRU)
The Issue: There is potential for the Reaction Vessels (RVs)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.