Medical Devices and Pharma
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Early Alert: Windstone Medical Recall for Convenience Kits
FDA Warns of Convenience Kits Containing Recalled Cardinal Health Alcohol Pads The FDA has issued an Early Alert regarding several medical convenience kits distributed by Windstone Medical Packaging, Inc. that contain alcohol prep pads previously recalled by Cardinal...
Webcol Alcohol Prep Pads Recall Due to Microbial Contamination
Cardinal Health Recalls Alcohol Prep Pads Over Infection Risk Concerns Cardinal Health has issued a voluntary nationwide recall of select lots of its Webcol™ Large Alcohol Prep Pads (70% isopropyl alcohol) after testing identified microbial contamination with...
FDA Expands Draeger Atlan Anesthesia Workstation Correction
More anesthesia machines added to correction for potential ventilation failure The U.S. Food and Drug Administration (FDA) has designated a recent expansion of Draeger, Inc.'s Atlan anesthesia workstation correction as a Class I recall, the agency's most serious...
Abiomed Issues Correction for Automated Impella Controllers
Hardware Updates Required to Address Potential Loss of Hemodynamic Support Abiomed has issued a correction for certain Automated Impella Controllers (AICs) used with the Impella heart pump system after identifying hardware-related issues that could lead to controller...
One Contaminated Alcohol Pad, Multiple Recalls
A Lesson in Medical Device Supply Chain Quality At first glance, Cardinal Health's recent recall of Webcol™ Alcohol Prep Pads appears straightforward. A commonly used healthcare product was found to be contaminated with Paenibacillus phoenicis, creating a potential...
Early Alert: Windstone Medical Recall for Convenience Kits
FDA Warns of Convenience Kits Containing Recalled Cardinal Health Alcohol Pads The FDA has issued an Early Alert regarding several medical convenience kits distributed by Windstone Medical Packaging, Inc. that contain alcohol prep pads previously recalled by Cardinal...
Webcol Alcohol Prep Pads Recall Due to Microbial Contamination
Cardinal Health Recalls Alcohol Prep Pads Over Infection Risk Concerns Cardinal Health has issued a voluntary nationwide recall of select lots of its Webcol™ Large Alcohol Prep Pads (70% isopropyl alcohol) after testing identified microbial contamination with...
FDA Issues Warning Letter for Modifications to Infant Products
FDA Issues Warning Letter to Happiest Baby Over SNOO Smart Sleeper Modifications and Quality System Deficiencies The U.S. Food and Drug Administration has issued a Warning Letter to Happiest Baby, Inc., manufacturer of the SNOO Smart Sleeper, citing unapproved device...
FDA Warns Wild Arabic Herbs Over Product Cancer Claims
FDA Warns Wild Arabic Herbs Over Cancer Claims for Herbal Product FDA issued a warning letter to Wild Arabic Herbs after reviewing the company’s website and determining that its “Edral-17t” product was marketed as an unapproved new drug. FDA cited claims that the...
FDA Warns Amazon for Unapproved Drugs Sold On Its Website
FDA Issues Warning Letter to Amazon for Unapproved Drug Products FDA issued a warning letter to Amazon.com, Inc. after purchasing and reviewing products sold through Amazon’s website and fulfilled through Amazon’s logistics network. The products identified were...
FDA Warns Leading Edge Health Over Unapproved New Drugs
FDA Warning Letter Targets Erectin Stimulating Gel and VigRX Delay Wipes FDA issued a warning letter to Leading Edge Health Inc. after reviewing the company’s website and determining that two sexual health products were being marketed as unapproved new drugs. The...
FDA Targets Online Marketing of Unapproved Drugs
FDA Issues 14 Warning Letters Targeting Online Unapproved Drug Sales The U.S. Food and Drug Administration (FDA) has issued a coordinated series of warning letters targeting companies marketing unapproved drug products online, signaling an intensified enforcement...
FDA Approves First Veterinary Amlodipine for Feline Hypertension
The U.S. Food and Drug Administration has approved Amodip (amlodipine besylate) chewable tablets for the control of systemic hypertension in cats. This approval marks a regulatory milestone as the first FDA-approved amlodipine product for veterinary use and the second...
Revival Animal Health Recalls Canine Milk Replacers
Revival Animal Health Recalls Canine Milk Replacers Due to Variable Vitamin D Levels Revival Animal Health, LLC of Orange City, Iowa, has voluntarily recalled multiple lots of its Breeder’s Edge® Foster Care® Canine Milk Replacer and Shelter’s Choice® Canine Milk...
FDA Approves First Generic for Equine Gastric Ulcers
FDA Approves First Generic Omeprazole Paste for Gastric Ulcers in Horses The U.S. Food and Drug Administration has approved Gastrobim (omeprazole) oral paste, the first generic version of a widely used treatment for gastric ulcers in horses. Gastrobim is indicated for...
Elite Treats Recalls Chicken Chips for Dogs
Elite Treats Recalls Chicken Chips for Dogs Due to Salmonella Risk On February 24, 2026, Elite Treats, LLC. announced a recall of a single lot of Chicken Chips for Dogs due to potential contamination with Salmonella — a pathogen that poses risks to both animal and...
Kian Pee Wan Capsules Recalled for Undeclared Drug Ingredients
Kian Pee Wan Capsules Recalled Due to Undeclared Drug Ingredients Aphreseller (Buy-herbal.com), an online seller based in Flushing, New York, has voluntarily recalled all lots of Kian Pee Wan capsules after testing identified the presence of undeclared drug...
FDA Recalls “Sexual Enhancement” Supplements
FDA Recall Highlights Ongoing Risks of Adulterated “Sexual Enhancement” Supplements Pure Vitamins and Natural Supplements, LLC (Tampa, FL) has issued a voluntary nationwide recall of several honey-based dietary supplement products after FDA laboratory testing detected...
How the Moringa Outbreaks Could Have Been Prevented
How This Could Have Been Prevented: A Quality Systems Perspective An MDP Consumer and Industry Brief After multiple moringa-linked Salmonella events, one uncomfortable truth is now clear. Even under DSHEA, manufacturers can do far more to prevent microbial...
Now the Salmonella in Moringa Is Drug-Resistant
Now the Salmonella in Moringa Is Drug-Resistant. That Changes the Stakes. An MDP Consumer and Industry Brief Salmonella contamination is serious in any consumer product. But one of the most concerning developments in the latest moringa-related outbreak investigation...
FDA Warns Wild Arabic Herbs Over Product Cancer Claims
FDA Warns Wild Arabic Herbs Over Cancer Claims for Herbal Product FDA issued a warning letter to Wild Arabic Herbs after reviewing the company’s website and determining that its “Edral-17t” product was marketed as an unapproved new drug. FDA cited claims that the...
FDA Warns Amazon for Unapproved Drugs Sold On Its Website
FDA Issues Warning Letter to Amazon for Unapproved Drug Products FDA issued a warning letter to Amazon.com, Inc. after purchasing and reviewing products sold through Amazon’s website and fulfilled through Amazon’s logistics network. The products identified were...
FDA Warns Leading Edge Health Over Unapproved New Drugs
FDA Warning Letter Targets Erectin Stimulating Gel and VigRX Delay Wipes FDA issued a warning letter to Leading Edge Health Inc. after reviewing the company’s website and determining that two sexual health products were being marketed as unapproved new drugs. The...
FDA Targets Online Marketing of Unapproved Drugs
FDA Issues 14 Warning Letters Targeting Online Unapproved Drug Sales The U.S. Food and Drug Administration (FDA) has issued a coordinated series of warning letters targeting companies marketing unapproved drug products online, signaling an intensified enforcement...
FDA Warns Wild Arabic Herbs Over Product Cancer Claims
FDA Warns Wild Arabic Herbs Over Cancer Claims for Herbal Product FDA issued a warning letter to Wild Arabic Herbs after...
FDA Warns Amazon for Unapproved Drugs Sold On Its Website
FDA Issues Warning Letter to Amazon for Unapproved Drug Products FDA issued a warning letter to Amazon.com, Inc. after...
FDA Warns Leading Edge Health Over Unapproved New Drugs
FDA Warning Letter Targets Erectin Stimulating Gel and VigRX Delay Wipes FDA issued a warning letter to Leading Edge Health...
FDA Targets Online Marketing of Unapproved Drugs
FDA Issues 14 Warning Letters Targeting Online Unapproved Drug Sales The U.S. Food and Drug Administration (FDA) has issued...
FDA Approves First Treatment to Reduce Risk of Acute Pancreatitis
FDA Approves First Treatment Proven to Reduce Acute Pancreatitis Risk in Severe HypertriglyceridemiaAn important example of...
One Contaminated Alcohol Pad, Multiple Recalls
A Lesson in Medical Device Supply Chain Quality At first glance, Cardinal Health's recent recall of Webcol™ Alcohol Prep...
Welcome to Medical Devices and Pharma, a website dedicated to providing timely and relevant medical device and pharma information to the regulated medical device and pharmaceutical industries, and consumers of those products.
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