Recalls and Safety Alerts:
Interference between CT and Electronic Medical Devices
This website provides information about a rare and preventable type of interference between Computed Tomography (CT) and electronic medical devices…
FDA Information on Heater-Coolers
This website contains information for patients, the FDA’s recommendations for health care providers and health facilities that use these devices and steps the FDA is taking to help minimize the risk of infections associated with these devices…
OxySure Portable Emergency Oxygen System, Model 615 by OxySure Therapeutics, Inc: FDA Safety Communication
FDA recommends consumers, businesses, schools, and health care providers stop using these devices because of several device malfunctions…
FDA Proposes Ban on Most Powdered Medical Gloves
The FDA is proposing to ban most powdered gloves in the U.S. While use of these gloves is decreasing, they pose an unreasonable and substantial risk of illness or injury to health care providers, patients and other individuals who are exposed to them, which cannot be corrected through new or updated labeling…
GlideScope Titanium Single-Use Video Laryngoscope by Verathon: Class I Recall
Recall due to potential disruption in the video feed from the camera in the laryngoscope blades to the monitor…
Duodenoscope Models TJF-160F and TJF-160VF by Olympus: Safety Communication
Olympus has issued updated, validated manual reprocessing instructions for these duodenoscopes to replace those provided in the original device labeling…
Arrow International Intra-Aortic Balloon Catheter Kits and Percutaneous Insertion Kits by Teleflex Incorporated : Class I Recall
The product is being recalled because the sheath body may become separated from the sheath hub…
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