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Alvogen Issues Voluntary Nationwide Recall for One Lot of Fentanyl Transdermal System 25 mcg/h Due to a Defective Delivery System

Alvogen, Inc. is voluntarily recalling one lot of Fentanyl Transdermal System 25 mcg/h transdermal patches to the consumer level. The…

Update on Alert: Infusion Pump Issue from Fresenius Kabi USA

This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program

Update on Alert: Endoscope Accessories Forceps/Irrigation Plug Issue from Olympus

This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program

Gas Powered Emergency Resuscitator Recall: Mercury Medical Removes Neo-Tee T-Piece Resuscitator Due to An Undersized Spring in The Controller That May Prevent the Device from Delivering the Required Pressure Levels Needed for Effective Ventilation

Mercury Medical recalls the Neo-Tee T-Piece Resuscitator due to the controller potentially not delivering the pressure levels needed for effective…

Update on Alert: Nephroscope Sheath Issue from Trokamed GmbH

This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program

Update on Alert: Fluid Delivery Set Issue from Medline

This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program

United Natural Trading LLC Announces Allergy Alert for Undeclared Milk in Fresh Direct Dark Chocolate Covered Pretzels

January 29, 2025 – United Natural Trading LLC, Edison, NJ, is voluntarily recalling Fresh Direct Dark Chocolate Covered Pretzels due…

Glucose and Glucose/Ketone Meter Correction: Nova Biomedical Corporation Issues Software Correction for StatStrip Glucose and Glucose/Ketone Hospital Meters Due to Risk for Transmission of Incorrect Patient Results

StatStrip Hospital Glucose and Ketone Meters provide blood glucose and ketone readings in health care settings. A software issue may…

Cybersecurity Vulnerabilities with Certain Patient Monitors from Contec and Epsimed: FDA Safety Communication

The FDA is raising awareness about cybersecurity vulnerabilities with Contec CMS8000 and Epsimed MN-120 patient monitors.

Olympus Issues Medical Device Advisory Notice to Use Alternative Devices to the MAJ-891 Forceps/Irrigation Plug

Olympus Corporation has announced a voluntary Advisory Notice for the Forceps/Irrigation Plug (Isolated Type) model MAJ-891 related to the risk…