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…
FDA D.I.S.C.O. Burst Edition: FDA approval of Ryoncil (remestemcel-L-rknd) for steroid-refractory acute graft versus host disease in pediatric patients
Podcast Welcome back to the D.I.S.C.O., FDA’s Drug Information Soundcast in Clinical Oncology, Burst Edition, brought to you by FDA’s Division of Drug Information in partnership with FDA’s Oncology Center of Excellence. Today we’ll provide a quick update on a recent FDA cancer therapeutic approval. On December 18, 2024, the FDA approved remestemcel-L-rknd (brand name…
Early Alert: Infusion Pump Software Issue from Fresenius Kabi USA
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…
Update: Evaluation of Airborne Chemicals from Neonatal Incubators – Letter to Health Care Providers
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…
Avoid Queso Fresco-Type Cheeses if You’re in High-Risk Groups
Image The U.S. Food and Drug Administration recommends pregnant people, adults aged 65 and older, and people who have weakened immune systems avoid eating all queso fresco-type cheeses. The recommendation is included in updated consumer education materials from FDA’s Human Foods Program. Queso fresco-type cheeses are highly susceptible to the bacteria (germ) Listeria, which can…
Endoscopic Vessel Harvesting (EVH) System Correction: Getinge and Maquet Cardiovascular Update Use Instructions for VasoView HemoPro 2 (VH-4000 and VH-4001) EVH Systems due to Risk for Bent or Detached Heater Wires and Silicone Peeling or Detaching During Use
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…
Animal Welfare, Testing and Research of FDA-Regulated Products
Image Medical and veterinary products save lives every day. FDA-regulated products such as blood pressure medicine, chemotherapy and MRI machines help people and animals live longer and healthier. The U.S. Food and Drug Administration regulates human and animal medical products to ensure they are safe and effective. Products undergo different types of testing to determine…