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2024 Medical Device Recalls
2024 Medical Device Recalls
http://www.fda.gov/medical-devices/medical-device-recalls/2024-medical-device-recalls
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Insulet Recalls Omnipod DASH Insulin Management System’s Personal Diabetes Manager (PDM) for Risk of Battery Swelling, Leakage, or Extreme Overheating
Omnipod DASH Insulin Management System’s Personal Diabetes Manager may have battery issues including swelling, fluid leakage, and extreme overheating.
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UPDATE: Change in Reprocessing Methods with Certain Karl Storz Urological Endoscopes – Letter to Health Care Providers
Do not use high-level disinfection methods for reprocessing affected urological endoscopes from Karl Storz.
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2024 Safety Communications
Listing of Medical Device 2024 Safety Communications
http://www.fda.gov/medical-devices/safety-communications/2024-safety-communications
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Oxygenator Devices Used for Extracorporeal Circulation – Letter to Health Care Providers
Learn about the issue, the FDA’s recommendations and actions, how to report a problem, and contact information.
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Update: Potential Risk of Exposure to Toxic Compounds When Using Hemodialysis and Peritoneal Dialysis Systems – Letter to Health Care Providers
The FDA expanded its evaluation of the potential risk of exposure to toxic compounds when using hemodialysis and peritoneal dialysis systems
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Risks with Exactech Equinoxe Shoulder System with Defective Packaging – FDA Safety Communication
Equinoxe Shoulder Systems were packaged in defective bags. Potential risks including premature implant wear or failure, which may lead to additional surgery.
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Recall of Certain Saline and Sterile Water Medical Products Associated with Nurse Assist: FDA Safety Communication
Nurse Assist, LLC announced a recall because the products may not be sterile. Patients are at risk of infection.
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2023 Safety Communications
Listing of Medical Device 2023 Safety Communications
http://www.fda.gov/medical-devices/safety-communications/2023-safety-communications
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Evaluating Plastic Syringes Made in China for Potential Device Failures: FDA Safety Communication
Consider using plastic syringes not manufactured in China, if possible.
