The FDA issued an update on the recommendations about the potential for exposure to airborne chemicals from neonatal incubators. Read More (external link)...
Continue readingThis communication is part of the Communications Pilot to Enhance the Medical Device Recall Program Read More (external link)...
Continue readingNew York Mutual Trading Co., Inc of Secaucus, NJ is recalling 7.05 oz of Prepared Monkfish Liver (Ankimobo) because the package label contains undeclared milk allergen. People who have an allergy or severe sensitivity to milk allergen run the risk of serious or life-threatening allergic reaction if Read More (external link)...
Continue readingHemoPro EVH Systems have updated instructions related to bent/detached heater wires and peeling/detaching silicone during minimally invasive surgery. Read More (external link)...
Continue readingJanuary 14, 2025 – The Quaker Oats Company today issued a recall of a limited number of two pound boxes of Pearl Milling Company Original Pancake & Waffle Mix that may contain undeclared milk, after being alerted by a retail partner. Those with an allergy or severe sensitivity to milk run the risk o Read More (external link)...
Continue readingMax Mobility/Permobil has initiated a nationwide recall of the Speed Control Dial component used with the SmartDrive MX2+ Power Assist Device due to potential safety and performance concerns. Read More (external link)...
Continue readingFDA-OCI, McKinsey & Company, McKinsey, McKinsey & Co., Martin Elling, Abingdon, Virginia, Bangkok, Thailand Read More (external link)...
Continue readingPhilips Monitoring Service Application processes mobile cardiac telemetry data but failed to send critical data for review by healthcare professionals. Read More (external link)...
Continue readingLifestyle Evolution Inc., is recalling select lots of NuGo Dark Chocolate Chip and Dark Chocolate Pretzel nutrition bars because they may contain undeclared milk. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume Read More (external link)...
Continue readingThe Mochi Ice Cream Company LLC, Vernon, California is recalling 1350 cases of Peach Mango Sorbet, because it may contain undeclared pasteurized cooked egg white. People who have an allergy or severe sensitivity to eggs, run the risk of serious or life-threatening allergic reaction if they consume t Read More (external link)...
Continue readingFDA Requires Guillain-Barré Syndrome (GBS) Warning in the Prescribing Information for RSV Vaccines Abrysvo and Arexvy: FDA Safety Communication Read More (external link)...
Continue readingDierbergs is recalling all 16oz Premium Home-Style Mashed Potatoes with a Sell By Date of January 09, 2025. The product carries an undeclared allergen of Wheat. The affected product is identifiable by a label ID number of 92 in the lower left-hand corner above the UPC code. Read More (external link)...
Continue readingThe FDA posts letters to health care providers about the safe use of medical devices. Read More (external link)...
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Firm integrates scientific knowledge and regulatory expertise to offer comprehensive legal solutions and scientific guidance to life science companies. FORT LAUDERDALE, Fla.--(BUSINESS WIRE)--Edgar J. Asebey, a seasoned attorney with over 20 years of FDA regulatory law experience, has launched Asebey Life Science Law, a boutique law firm specializing in FDA regulatory law, transactional law, and strategic advisory services for the life sciences industry. As a former scientist, biotech founder, venture capital fund advisor, and equity partner at an AM 100 law firm, Edgar is uniquely qualified to lead a firm that provides much needed regulatory guidance, enforcement defense and industry expertise to FDA-regulated...
Continue readingVivo 45 LS ventilators support breathing in homes and health settings. New devices may expose users to elevated formaldehyde levels for a short time. Read More (external link)...
Continue readingGutierrez Distributor of Passaic, NJ is recalling El Servidor Corp brand ground cinnamon because it has the potential to be contaminated with elevated levels of lead. Short term exposures to very low levels of lead may not elicit any symptoms. It is possible that increased blood lead levels may be t Read More (external link)...
Continue readingUPDATE: Evaluating Plastic Syringes Made in China for Potential Device Failures: FDA Safety Communication Read More (external link)...
Continue readingListing of Medical Device 2024 Safety Communications Read More (external link)...
Continue readingFDA-OCI, Boston, Massachusetts, Mohammad Diab, Moe Diab, Glendale, California, Amy Rountree, Logan, Utah, Allied Wallet, Inc. Read More (external link)...
Continue readingFDA-OCI, Biloxi, Mississippi, Robert Leon Deming III, The Candy Shop LLC Read More (external link)...
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