Medical Devices and Pharma
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Class I Recall for Bolton Medical RelayPro Thoracic Stent Graft
FDA Issues Class I Recall for RelayPro Thoracic Stent Graft Following Three Patient DeathsDeployment failure during aortic repair may require emergency open surgery The U.S. Food and Drug Administration (FDA) has issued a Class I recall for certain RelayPro Thoracic...
Arrow Corrects Kits With Recalled Injectable Medications
FDA Classifies Field Correction As Class I Recall Due to Risk of Serious Injury The U.S. Food and Drug Administration (FDA) has classified a correction issued by Arrow International, a subsidiary of Teleflex, as a Class I recall after certain convenience kits were...
FDA Issues Early Alert for Resmed Astral Ventilators
Resmed VentilatorPatients should continue using devices unless instructed otherwise by their healthcare provider The U.S. Food and Drug Administration (FDA) has issued an Early Alert regarding a potentially high-risk issue affecting certain Resmed Astral 100 and...
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...
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 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...
Why the Sudden Focus on Testosterone?
New Military Screening Program Raises Questions About Science, Strategy and TransparencyThe Trump administration's decision to begin annual testosterone screening for active-duty and reserve service members age 30 and older has generated headlines and a growing number...
Arrow Corrects Kits With Recalled Injectable Medications
FDA Classifies Field Correction As Class I Recall Due to Risk of Serious Injury The U.S. Food and Drug Administration (FDA) has classified a correction issued by Arrow International, a subsidiary of Teleflex, as a Class I recall after certain convenience kits were...
FDA Approves First Oral PCSK9 Inhibitor for High Cholesterol
FDA Approves Lipfendra, the First Oral PCSK9 Inhibitor for High CholesterolLipfendra offers patients a once-daily pill alternative to injectable PCSK9 therapies The U.S. Food and Drug Administration (FDA) has approved Lipfendra (enlicitide), the first oral medication...
FDA Approves Retevmo for RET Fusion-Positive Solid Tumors
FDA Grants Full Approval to Retevmo for RET Fusion-Positive Metastatic Solid TumorsApproval expands precision medicine option for adults and children with advanced cancers The U.S. Food and Drug Administration (FDA) has granted traditional approval to Retevmo...
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...
Quest Cat Food Recall Expanded Due to Low Thiamine Levels
Quest Cat Food Recall Expanded Due to Low Thiamine Levels On February 26, 2026, Go Raw LLC expanded its voluntary recall of certain Quest Diet Cat Food products after identifying potentially low levels of thiamine (Vitamin B1), an essential nutrient for feline health....
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...
Why These Salmonella Outbreaks Keep Happening
Why These Salmonella Outbreaks Keep Happening: “Illness First, Controls Later” An MDP Consumer and Industry Brief When people hear “FDA is investigating,” they often assume the system detected a safety problem early and intervened. In many dietary supplement...
Arrow Corrects Kits With Recalled Injectable Medications
FDA Classifies Field Correction As Class I Recall Due to Risk of Serious Injury The U.S. Food and Drug Administration (FDA) has classified a correction issued by Arrow International, a subsidiary of Teleflex, as a Class I recall after certain convenience kits were...
FDA Approves First Oral PCSK9 Inhibitor for High Cholesterol
FDA Approves Lipfendra, the First Oral PCSK9 Inhibitor for High CholesterolLipfendra offers patients a once-daily pill alternative to injectable PCSK9 therapies The U.S. Food and Drug Administration (FDA) has approved Lipfendra (enlicitide), the first oral medication...
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...
Editorial: Two Days Later, Another Moringa Recall
Recurring Moringa Recalls Highlight Ongoing Supply Chain Concerns On July 17, the U.S. Food and Drug Administration...
Moringa Capsules Recalled for Potential Salmonella Contamination
Zen Principle Recalls Moringa Capsules After FDA Detects Salmonella in Raw Ingredient Relay Peak Research LLC, doing...
Eight Months of Moringa Salmonella Outbreaks
Recurring Salmonella Outbreaks Raise Questions About Supplement Oversight Since November 2025, the U.S. Food and Drug...
FDA Closes Moringa Salmonella Outbreak Investigation
The U.S. Food and Drug Administration and the Centers for Disease Control and Prevention have concluded their investigation...
FDA Early Alert for Baxter Intravascular Administration Sets
Healthcare facilities are instructed to immediately stop using affected IV solution sets while FDA evaluates the...
Why the Sudden Focus on Testosterone?
New Military Screening Program Raises Questions About Science, Strategy and TransparencyThe Trump administration's decision...
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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