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 27541–27560 of 38,428 recalls
Recalled Item: X-Ray Diagnostic Table
The Issue: Report of unintentional movement of table to reverse
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Mach 4 Mouse Probe vial within the Mach 4 Universal HRP-Polymer Kit
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AMD-RITMED brand Conforming Stretch Gauze Bandages
The Issue: The product lot did not meet sterility requirements
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ADVIA Centaur CP Immunoassay System
The Issue: The firm identified an issue in sample processing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: reVive Light Therapy Pain Relief Device (Model Number: RVPNSYS) Product
The Issue: Incorrect Power Supply in the package, rendering the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Pleur-evac Chest Drainage System
The Issue: The label on the Tyvek bag is missing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ev3
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ad-Tech Electrode Connection System/Cables. Lightweight TECH-ATTACH Cable...
The Issue: Ad-Tech is recalling unopened/unused sterile cables intended to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Merge Eye Station Import Utility (ESIU) when used with Merge
The Issue: Eye Station images were not importing properly and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Merge Hemo software. Merge Hemo monitors
The Issue: There is a potential connection issue when powering
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Merge Cardio software. Product Usage: Merge Cardio is a system
The Issue: If a reader selects Multi-study review prior to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Merge Cardio software. Merge Cardio is a system intended to
The Issue: If images are sent without an order in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Merge PACS software. Merge PACS (Picture Archiving Communication System) is
The Issue: Cut lines on the image may present horizontally
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Merge PACS software. Product Usage: Merge PACS (Picture Archiving Communication
The Issue: The software did not show unviewed images when
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ergon III Series Skyboom Monitor Bracket. Part # 3FCM1 Flatscreen Bracket
The Issue: for the weld to fail at the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ANSPACH
The Issue: Certain lots of the Otologic Curved Micro (OCM)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ANSPACH
The Issue: Certain lots of the Otologic Curved Micro (OCM)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PneumoSure XL High Flow Insufflator and PneumoSure High Flow Insufflator
The Issue: When operating the device in high flow mode
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Trypticase TM Soy Agar with 5% Sheep Blood (TSA IITM)
The Issue: Listeria Contamination
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The Spacelabs Healthcare Xhibit Telemetry Receiver (XTR)
The Issue: Reports of an abnormally high frequency of squelch
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.