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 37621–37640 of 38,428 recalls
Recalled Item: IDEV Technologies SUPERA VERITAS Interwoven Self-Expanding Nitinol Stent...
The Issue: There was an error on the outer labeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Advantage Workstation Volume Share 2 (versionAW4.4_04) with Volume Viewer 3
The Issue: GE Healthcare has became aware of two issues
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Trinity Biotech
The Issue: The Positive Control for the Captia Varicella-Zoster Virus
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Acrobat 3000 (AC3000) Spring Arm as support arm for iLED operating lights
The Issue: Cracks can arise on the welded seam on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: This voluntary medical device correction is related to Alcon products
The Issue: This medical device correction is related to Alcon
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: syngo(R) Lab Data Manager and syngo(R) Lab Process Manager
The Issue: When using the syngo Quality Control package the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TRESTLE LUXE¿ Anterior Cervical Plating System
The Issue: On May 9th 2012 Alphatec Spine received a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EasyLink Informatic System is included with the Dimension Vista System.
The Issue: When using the EasyLink Quality Control Package the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Horizon Medical Imaging system. Product Usage: Horizon Medical Imaging is
The Issue: There is a potential to save reports in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Maquet Getinge Group Pediatric Arterial Cannula Maquet Cardiopulmonary AG Kehler
The Issue: Certain pediatric arterial cannulas may have limited flexibility
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AirLife Isothermal Breathing Circuit Accessory - Infant Patient Y Connector
The Issue: The Y adapter within the breathing circuit may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AirLife Isothermal Breathing Circuit
The Issue: The Y adapter within the breathing circuit may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AirLife Isothermal Breathing Circuit
The Issue: The Y adapter within the breathing circuit may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Microbiologics 217 Osseo Avenue North
The Issue: E. coli Contamination
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MULTIGENT Acetaminophen for use with Architect/Aeroset Cat. No. 2K99-20. Assay
The Issue: Discoloration of the acetaminophen enzyme reagent (R1), generates
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare Volume Viewer Plus 5.x (Advantage Workstation 4.2) Volume
The Issue: Incorrect views and measurements possible. GE Healthcare became
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alaris PC unit model 8015 Product Usage: The device is
The Issue: The recall was initiated because the Alaris PC
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Getinge brand --- large capacity
The Issue: Getinge Disinfection AB is voluntarily correcting Washer Disinfectors,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AdvantageSim MD versions 7.4 through 7.6
The Issue: It was reported by a customer site that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare
The Issue: GE Healthcare has recently become aware of inaccurate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.