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Date Issued: January 3, 2024 The U.S. Food and Drug Administration (FDA) is providing recommendations for health care providers considering using the Total Hip System, including resurfacing implants, manufactured by Synovo Production, Inc. (Synovo) and for …
Please be aware, this recall is a correction, not a product removal. The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Recalled Product Device Use The EVair and Jun- …
December 27, 2023 The U.S. Food and Drug Administration (FDA) is reminding health care providers and clinical laboratory staff about the potential for false reactive (false positive) results in herpes simplex virus type 2 (HSV-2) serological tests for …
Summary Company Announcement Date: December 21, 2023 FDA Publish Date: December 26, 2023 Product Type: Drugs Reason for Announcement: Recall Reason Description Presence of Glass Particulate Matter Company Name: Hospira, Inc. Brand Name: Product Description …
COMPANY ANNOUNCEMENT When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company. Read Announcement View Product Photos …
COMPANY ANNOUNCEMENT When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company. Read Announcement View Product Photos …
COMPANY ANNOUNCEMENT When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company. Read Announcement Summary Company …
COMPANY ANNOUNCEMENT When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company. Read Announcement Summary Company …
Please be aware, this recall is a correction, not a product removal. The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Recalled Product Product Names: Panorama 1.0T …
COMPANY ANNOUNCEMENT When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company. Read Announcement View Product Photos …
Español Update: December 19, 2023 Additional Related Recalls of Saline and Sterile Water Medical Products Associated with Nurse Assist In direct response to the Nurse Assist, LLC recall on November 6, 2023, distributors of Nurse Assist water-based medical …
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Please be aware, this recall is a correction, not a product removal. Recalled Product Product Names: Olympus …
Please be aware, this recall is a correction, not a product removal. The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Recalled Product Product Names: StealthStation …
COMPANY ANNOUNCEMENT When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company. Read Announcement Summary Company …
Date Issued: November 30, 2023 The U.S. Food and Drug Administration (FDA) is informing consumers, health care providers, and health care facilities that the FDA is evaluating the potential for device failures (such as leaks, breakage, and other problems) …
COMPANY ANNOUNCEMENT When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company. Read Announcement View Product Photos …
[Posted 11/28/2023] TOPIC: BCMA-Directed or CD19-Directed Autologous Chimeric Antigen Receptor (CAR) T cell Immunotherapies: FDA Safety Communication - FDA Investigating Serious Risk of T-cell Malignancy AUDIENCE: Patient, Health Professional, Risk Manager …
Date Issued: November 28, 2023 The U.S. Food and Drug Administration (FDA) is warning patients and health care providers to carefully monitor Philips DreamStation 2 continuous positive airway pressure (CPAP) machines for signs of overheating. The FDA …
[Posted 11/28/2023] AUDIENCE: Patient, Health Professional, Neurology, Dermatology, Allergy and Immunology, Pharmacy ISSUE: The FDA is warning that the antiseizure medicines, Keppra, Keppra XR, Elepsia XR, Spritam (levetiracetam) and Onfi, Sympazan ( …
