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 25341–25360 of 38,428 recalls
Recalled Item: C2 CryoBalloon Ablation System - Controller Cap. C2 CryoBalloon Controller
The Issue: The Controller Cap of the C2 CyroBalloon Ablation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Color contact lenses labeled under the following brands: Diamond
The Issue: Sterility and Misbranding: Lenses may not be sterile
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hitachi Oasis MRI System - C-Spine Coil
The Issue: The customer indicated that the coil balun was
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EyeSuite i.8.2.1.0 Software for ophthalmic use including selection of Intra
The Issue: There is a possibility for data to be
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS Chemistry Products FS Calibrator 1
The Issue: The company received a customer complaint for the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Spare Disk Remover Module
The Issue: The firm became aware that the ball bushing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Genetic Screening Processor (GSP)
The Issue: The firm became aware that the ball bushing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IMMULITE 2000 Progesterone
The Issue: DHEA-S causes falsely elevated progesterone results
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IMMULITE/ IMMULITE 1000 Progesterone
The Issue: DHEA-S causes falsely elevated progesterone results
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dimension Vista LOCI Progesterone
The Issue: DHEA-S causes falsely elevated progesterone results
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ADVIA Centaur Progesterone
The Issue: DHEA-S causes falsely elevated progesterone results
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vanguard Total Knee System Vanguard Open Box Femoral Components Item
The Issue: packaging of some femoral components was incorrectly labeled
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Maintenance Kit PH2
The Issue: Baxter Healthcare Corporation is issuing a voluntary product
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Maintenance Kit PH1
The Issue: Baxter Healthcare Corporation is issuing a voluntary product
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AFX2 Endovascular AAA System Item No. Item Description F00820-01...
The Issue: Endologix updated information on the rates of Type
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AFX Endovascular AAA System Item Number Item Description F0070305 A2525/C75
The Issue: Endologix updated information on the rates of Type
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Arthrex Shoulder Suspension Tower
The Issue: During use, there is a potential scenario which
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 9805 Orbital Volume Sizer Set with Tray (Non-sterile) 9951 Design
The Issue: An incorrect sterility status on the label, non-sterile
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: QUINTUBE Monitor Pack (5 tubes/pk
The Issue: An incorrect sterility status on the label, non-sterile
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alpha Air 6 ENT Microscope Microscope examination of the human ear
The Issue: The microscope may tip over if attachments are
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.