This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program. This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it. The affected…
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
This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it. Affected Product What to Do On December 5, 2024, Mercury Medical sent all affected customers an Urgent…
Pressure Monitoring Device Recall: Medtronic Neurosurgery Issues Correction for Becker and Exacta External Drainage and Monitoring Systems Due to Cracks And/Or Leaks in Stopcocks
This recall involves correcting certain devices, and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it without correction. Affected Product Product Names: Becker External Drainage and Monitoring…
Update on Alert: Nephroscope Sheath Issue from Trokamed GmbH
This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program. This recall involves updating instructions for using certain devices, and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or…
Update on Alert: Fluid Delivery Set Issue from Medline
99000069 FDS, 135, CHMN, W/F, MLL, RC(2), PG 0000128741 10193489069587 30193489069581 99000069 FDS, 135, CHMN, W/F, MLL, RC(2), PG 0000134505 10193489069587 30193489069581 99000069 FDS, 135, CHMN, W/F, MLL, RC(2), PG 0000133893 10193489069587 30193489069581 99000069 FDS, 135, CHMN, W/F, MLL, RC(2), PG 0000135769 10193489069587 30193489069581 99000069 FDS, 135, CHMN, W/F, MLL, RC(2), PG 0000139596 10193489069587 30193489069581…
Update on Alert: Extracorporeal Blood Circuit Issue from Nuwellis
This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program. This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it. The affected…
Olympus Issues Medical Device Advisory Notice to Use Alternative Devices to the MAJ-891 Forceps/Irrigation Plug
Summary Company Announcement Date: January 29, 2025 FDA Publish Date: January 30, 2025 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Risk of device contamination that may result from improper reprocessing. Company Name: Olympus Corporation Brand Name: Brand Name(s) Product Description: Product Description MAJ-891 endoscope accessory Company Announcement CENTER VALLEY, Pa., (January 29,…
Provepharm Inc. Issues Voluntary Nationwide Recall of One Lot of Phenylephrine Hydrochloride Injection, USP, 10 mg/ mL (Pharmacy Bulk Package) Due to Presence of Particulate Matter
Summary Company Announcement Date: January 24, 2025 FDA Publish Date: January 24, 2025 Product Type: Drugs Reason for Announcement: Recall Reason Description Device & Drug Safety – Potential Foreign Material Company Name: Provepharm Inc. Brand Name: Brand Name(s) Provepharm Inc. Product Description: Product Description Phenylephrine hydrochloride Injection, USP, 10 mg/ mL Company Announcement FOR IMMEDIATE…
Copaxone, Glatopa (glatiramer acetate): Drug Safety Communication – FDA Adds Boxed Warning About a Rare but Serious Allergic Reaction Called Anaphylaxis
[Posted 01/22/2025] AUDIENCE: Patient, Caregiver, Health Care Professional, Pharmacy, Neurology ISSUE: The FDA is warning about the risk of a rare but serious allergic reaction with the medicine glatiramer acetate (Copaxone, Glatopa), which is used to treat patients with multiple sclerosis (MS). This serious allergic reaction, called anaphylaxis, can occur at any time while on…
Max Mobility / Permobil Issues Nationwide Recall of SmartDrive Speed Control Dial Due to the Motor Being Unresponsive to the User
Summary Company Announcement Date: January 14, 2025 FDA Publish Date: January 17, 2025 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Due to potential safety and performance concerns. Company Name: Max Mobility, LLC. Brand Name: Brand Name(s) Max Mobility/Permobil Product Description: Product Description Speed Control Dial Component Company Announcement Reason for Voluntary Field…