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 15421–15440 of 38,428 recalls
Recalled Item: Omnipod DASH Insulin Management System (mmol/L configuration)
The Issue: After the device has been in use for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Giraffe Shuttle. Upgrade Kits with part number 2109672-001 and 2109673-001
The Issue: During Giraffe Shuttle charging, the batteries emit low
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PRESTIGE RETRACTION GRASPER
The Issue: Endoscopic graspers may become separated at the weld
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PRESTIGE ATRAUMATIC GRASPER W/PORT DUAL ACTION
The Issue: Endoscopic graspers may become separated at the weld
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS Chemistry Products CKMB Slides
The Issue: The Spanish and Swedish language versions of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS Chemistry Products CKMB Slides
The Issue: The Spanish and Swedish language versions of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ARCHITECT C Peptide Calibrator - Product Usage: used as an
The Issue: Error in the renewal documentation process for license
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ARCHITECT C Peptide Reagent - Product Usage: used as an
The Issue: Error in the renewal documentation process for license
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ARCHITECT C Peptide Calibrator - Product Usage: used as an
The Issue: Error in the renewal documentation process for license
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cortoss Bone Augmentation Material
The Issue: Shipments were transported outside of the required refrigerated
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Bridge Occlusion Balloon
The Issue: There is a potential for thrombus formation on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Analyte specific reagent. REF/UDI: 641408/641408-4012-1-1 (US)
The Issue: False positive reaction on the reagent
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: iChem¿VELOCITY Urine Chemistry System-
The Issue: A defect in the SATA power adapter cable
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: iQ200 Series Urine Microscopy Analyzer- All part numbers
The Issue: A defect in the SATA power adapter cable
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MoXy Laser Fiber
The Issue: To reinforce existing instructions within the Directions for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Leksell Vantage Stereotactic System. Instrument Carrier
The Issue: A faulty locking piece of the Instrument Carrier
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cardiovascular Reprocessed ViewFlex Xtra ICE Catheter
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sterile Oxymetry Oligon Catheter Kit. Pressure injectable....
The Issue: Sterile catheter kit packaging compromised
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Positron Emission Tomography and Computed Tomography System
The Issue: In affected software version, of Positron emission tomography
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VERTEX SELECT MULTI AXIAL SCREW. 4.0 X 38MM MULTI AXIAL SCREW. Lot H5517628
The Issue: Nonconforming product; length of the product measured shorter
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.