Update on Alert: Infusion Set Performance Issue from BD
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...What is a Medical Device Recall?
When a company learns that there is a problem with one of their medical devices, it proposes a correction or a removal depending on where the action takes place.Correction – Addresses a problem with a medical device in the place where it is used or sold.Removal...Georgia Nut Company (GNC), Third-Party Manufacturer for Tru Fru, LLC Issues Voluntary Recall of Specific Varieties of Tru Fru Freeze Dried Products Due to Potential Presence of Metal in Product
Summary Company Announcement Date: September 26, 2025 FDA Publish Date: September 29, 2025 Product Type: Food & Beverages Contaminants Reason for Announcement: Recall Reason Description Due to potential presence of metal in the product. Company Name: Georgia Nut...Guidance for Industry
Docket Number: FDA-2025-D-3023 Issued by: Guidance Issuing Office Center for Biologics Evaluation and Research Center for Drug Evaluation and Research The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry...Gansu Zhaofeng Agricultural Development Co., Ltd. Is Voluntarily Recalling Its Dried Bean Curd Due to Undeclared Wheat
Summary Company Announcement Date: September 26, 2025 FDA Publish Date: September 27, 2025 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Undeclared wheat allergen Company Name: Gansu Zhaofeng Agricultural Development Co., Ltd....SLR Food Distribution, Inc. Recalls Wise Wife Brand Ground Cinnamon Because of Possible Health Risk
Summary Company Announcement Date: September 26, 2025 FDA Publish Date: September 26, 2025 Product Type: Food & Beverages Spices, Flavors & Salts Contaminants Reason for Announcement: Recall Reason Description Potential to be contaminated with elevated...FDA approves new treatment for acromegaly, a rare endocrine disorder
ActionThe U.S. Food and Drug Administration (FDA) approved Palsonify (paltusotine) tablets to treat adults with acromegaly who have had an inadequate response to surgery and/or for whom surgery is not an option.Disease or ConditionAcromegaly is a rare endocrine...MedWatch: FDA Safety Information & Adverse Event Reporting Program
MedWatch, the FDA’s medical product safety reporting program for health professionals, patients and consumers.MedWatch receives reports from the public and when appropriate, publishes safety alerts for FDA-regulated products such as:Prescription and over-the-counter...Click To Verify Security & Validation
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