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...
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...
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...
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...
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...
FDA Warning Letters Target Online Ketamine Sellers
Seven Warning Letters Signal Increased FDA Scrutiny The U.S. Food and Drug Administration (FDA) has launched a coordinated enforcement action against websites marketing unapproved ketamine-related drug products, issuing seven Warning Letters on July 7, 2026, to online...
FDA Warning Letter Cites Illegal Drug Residue Levels in Dairy Cow
Letter Highlights FDA's Role in Protecting the Food Supply from Excessive Drug Residues When most people think about food safety inspections at slaughterhouses, they think of the U.S. Department of Agriculture. Few realize that the U.S. Food and Drug Administration...
FDA Warning Letter Targets Unapproved Fish and Bird Antibiotics
Letter Cites Unapproved Animal Drugs, Misbranding, and Antimicrobial Stewardship Concerns The U.S. Food and Drug Administration's Center for Veterinary Medicine (CVM) has issued a Warning Letter to The Fish Aid, an online distributor of antibiotics marketed for...
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...
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...
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...
SCA Pharmaceuticals LLC. Little Rock, AR. 483 Response issued 11/21/2025
Task Description Request Please post to the OII FOIA Electronic Reading Room Record Date 11/21/2025 Short Title (70 char)...
FDA Warning Letter Cites Illegal Drug Residue Levels in Dairy Cow
Letter Highlights FDA's Role in Protecting the Food Supply from Excessive Drug Residues When most people think about food...
FDA Warning Letter Targets Unapproved Fish and Bird Antibiotics
Letter Cites Unapproved Animal Drugs, Misbranding, and Antimicrobial Stewardship Concerns The U.S. Food and Drug...
Hillyard GMP
Hillyard GMP, Saint Joseph, MO, 2/27/26, 3009690111
CSL Plasma Inc
CSL Plasma Inc, Philadelphia, PA, 2/6/26, 3022099864
Blood Assurance Inc
Blood Assurance Inc, Tullahoma, TN, 2/17/26, 3005080452
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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