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…

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…

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…

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,…

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…

[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…

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…

This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program. The FDA has become aware of a potentially high-risk device issue. The FDA will keep the public informed and update this web page as significant new information becomes available. Affected Product The FDA is aware that Fresenius Kabi USA has…

January 16, 2025 The U.S. Food and Drug Administration (FDA) is providing an update on its evaluation of the potential for exposure to airborne chemicals that may be released from neonatal incubators. Based on the FDA’s review of the totality of the available information including testing data, we have determined that all new neonatal incubators…

The devices described in this recall are included in the related Letter to Health Care Providers. See the Letter to Health Care Providers for the most current information on these devices. This recall involves updating instructions for using devices, and does not involve removing them from where they are used or sold. The FDA has…