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 22481–22500 of 38,428 recalls
Recalled Item: ReNew Dolphin Nose Disposable Dissector Tip
The Issue: Certain lots of disposable laparoscopic instrument tips may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Proteus 235
The Issue: The internal configuration of the electrometers and the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ingenuity TF PET/CT - a integrated diagnostic X-ray Computed Tomography
The Issue: One of the two wire channels mounted inside
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ACE(TM) BRAND
The Issue: Mold was found on the non-patient contact surfaces
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Discover VH/Millennium VG Nuclear Medicine Imaging System
The Issue: A potential hazardous situation may occur if the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VariCam
The Issue: A potential hazardous situation may occur if the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CP5 Centrifugal Pump
The Issue: Possibility that the automatic line closure by the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ICU Mednet(TM) Medication Management Suite 6.1 and 6.21
The Issue: Issue 1: The MedNet Meds 6.1 and 6.21
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Plum 360 Infusion System
The Issue: (1) Under certain conditions, if a malfunction alarm
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OptiLITE
The Issue: It has been determined that a lot of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: fMRI Hardware System - AudioSystem
The Issue: Report was of an interrupted MR scan after
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Nucleic Acid test intended for screening for MRSA/SA. Each kit
The Issue: The cobas MRSA/SA tests may have decreased performance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: L3 Security & Detection System Cabinet X-ray system used for
The Issue: L3 has determined in airport environments, there have
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LIFEPAK(R) Electrode Starter Kits
The Issue: The infant artwork on the product instructs incorrect
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LIFEPAK(R) defibrillation electrodes
The Issue: The infant artwork on the product instructs incorrect
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Radial Artery Catheterization Kit
The Issue: The povidone iodine prep pads included in certain
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Radial Artery Catheterization Kit
The Issue: The povidone iodine prep pads included in certain
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Radial Artery Catheterization Kit
The Issue: The povidone iodine prep pads included in certain
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Radial Artery Catheterization Kit
The Issue: The povidone iodine prep pads included in certain
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Radial Artery Catheterization Kit
The Issue: The povidone iodine prep pads included in certain
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.