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 28581–28600 of 38,428 recalls
Recalled Item: MED-RX Single Use
The Issue: The product may be packaged with a 5
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ascom Mobile Monitoring Gateway (versions 4.1.1 and 4.2.0) and Ascom
The Issue: Due to a malfunction of software, the secondary
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Flow-i Anesthesia System Product Usage: The indication for the Flow-i
The Issue: Electrical issues in the control, monitoring or panel
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IBA Dosimetry GmbH Lift Table Type 4320
The Issue: When the electric lift table is connected to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Boston Scientific
The Issue: The literature packet packaged with the devices incorrectly
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Boston Scientific
The Issue: The literature packet packaged with the devices incorrectly
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Intelliport Medication Management System Sensor The system is indicated
The Issue: The sterility of the product cannot be assured
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Zimmer Periarticular Locking Plate System 3.5mm Locking Screw 58 mm Length
The Issue: Product on the package label did not match
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Zimmer Universal Locking System 3.5mm Locking Reconstruction Plate Straight 11
The Issue: The product on the package label did not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MOSAIQ Oncology Information System MOSAIQ is an oncology information system
The Issue: Incorrect drug dosage due to "Age Limit" and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips Lumify Diagnostic Ultrasound
The Issue: Color Flow direction is displayed incorrectly in Lumify
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SYNTHECEL Dura Repair
The Issue: It was reported that the SYNTHECEL Dura Repair
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SYNTHECEL Dura Repair
The Issue: It was reported that the SYNTHECEL Dura Repair
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SYNTHECEL Dura Repair
The Issue: It was reported that the SYNTHECEL Dura Repair
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SYNTHECEL Dura Repair
The Issue: It was reported that the SYNTHECEL Dura Repair
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SYNTHECEL Dura Repair
The Issue: It was reported that the SYNTHECEL Dura Repair
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AltiVate Reverse Humeral Broach
The Issue: The trial shell mating feature on the broach
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Perkin Elmer WIZARD2 10-detector
The Issue: The content of the second #023 barcode ID
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Perkin Elmer WIZARD2 1-detector
The Issue: The content of the second #023 barcode ID
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Perkin Elmer WIZARD2 1-detector
The Issue: The content of the second #023 barcode ID
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.