Medical Devices and Pharma
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Ethicon Issues Safety Alert for Surgical Stapler Cartridge
Endopath Echelon Vascular White Reload for Advanced Placement TipSource: FDAUrgent Class I Medical Device Recall Ethicon Endo-Surgery, LLC has issued an urgent correction for its Endopath Echelon Vascular White Reload for Advanced Placement Tip (35 mm, 4-row). This...
Device Recall Alert: Edwards Lifesciences Arterial Cannula
Edwards Lifesciences Arterial CannulaSource: FDAEdwards Lifesciences Recalls Arterial Cannulae Over Risk of Exposed Wire Edwards Lifesciences has issued a Class I recall of certain arterial cannula devices due to the risk of wire exposure near the cannula tip, which...
Device Recall: ZOLL AutoPulse NXT Resuscitation System
Urgent Class I Medical Device Recall ZOLL Circulation, Inc. has issued a Class I recall of its AutoPulse NXT Resuscitation System (Model 200, Software Version 2.0.1) due to a system error that may cause the device to stop chest compressions or deliver compressions...
Alert: Ventilator Systems Risk in Neonatal Tidal Volume Delivery
Maquet Servo Ventilator SystemsSource: FDAUrgent Class I Medical Device Correction Maquet Critical Care AB, a subsidiary of Getinge, has issued an urgent correction notice regarding its Servo Ventilator Systems (Servo-u, Servo-n, and Servo-u MR). This correction does...
FDA Approves Novel Device for Pancreatic Cancer Treatment
FDA Approves Novel Device for Pancreatic Cancer Treatment The U.S. Food and Drug Administration has approved Optune Pax, a first-of-its-kind medical device designed to treat adult patients with locally advanced pancreatic cancer. Developed by Novocure, the portable...
When Apparel Becomes a Medical Device
Lessons from FDA’s Breast Binder Warning Letters In December 2025, the FDA issued warning letters to several companies selling breast binders and chest compression garments online. The agency concluded that marketing claims on company websites, like statements about...
Labeling Correction for TRUE METRIX® Blood Glucose Meters
Labeling Correction for TRUE METRIX® Blood Glucose Meters Highlights the Critical Role of Clear Error Messaging Trividia Health, Inc. has initiated a labeling correction affecting all TRUE METRIX®, TRUE METRIX AIR®, TRUE METRIX GO®, and TRUE METRIX PRO® blood glucose...
When a “Good Enough” Design May Fail the User
Advancing from Basic Design to Usability In a world shifting toward user-centered regulation, even the simplest medical devices can demonstrate why human factors and usability engineering matter. The FDA’s Quality Management System Regulation (QMSR) – which aligns...
FDA Warning Letter Cites Key CGMP and Data Integrity Failures
FDA Warning Letter Highlights Fundamental CGMP and Data Integrity Failures The FDA has issued a Warning Letter to A. Nelson & Co. Ltd. citing significant violations of Current Good Manufacturing Practice (CGMP) requirements under 21 CFR Parts 210 and 211 at a...
FDA Approves First Generic Fenbendazole Oral Suspension
Defendazole™ (fenbendazole) 10% Oral Suspension The U.S. Food and Drug Administration has approved Defendazole™ (fenbendazole) 10% oral suspension, the first FDA-approved generic fenbendazole dewormer for use in beef and dairy cattle and goats. Defendazole is...
FDA Testosterone Panel Sparks Concern
Concerns Over Sudden Regulatory Shift The FDA’s December 2025 expert panel has recommended sweeping changes to testosterone regulation – a sharp departure from the agency’s long-standing cautionary stance for the hormone. The panel urged the FDA to broaden...
Testosterone Regulation Takes a Sharp Turn
Why FDA’s December Panel Raises Red Flags Regulatory Analysis The FDA’s regulation of testosterone therapy has long been a model of cautious, evidence-based policymaking. For more than a decade, the agency maintained a consistent position: testosterone was approved...
FDA Approves First Generic for Bovine Respiratory Disease
nixiFLOR, the first generic version of Resflor GOLD The U.S. Food and Drug Administration has approved nixiFLOR, an injectable solution combining florfenicol and flunixin meglumine, for the treatment of bovine respiratory disease (BRD) and the control of...
FDA Approves Drug to Delay Canine Congestive Heart Failure
Vetmedin is the first drug to go from an expanded conditional approval to fully approved The U.S. Food and Drug Administration has fully approved a new use for Vetmedin (pimobendan) chewable tablets, making it the first drug officially recognized to delay the onset of...
FDA Completes Risk Review of Canine Freeze-Dried Plasma
Freeze-Dried Plasma for Emergency Use in Dogs The U.S. Food and Drug Administration (FDA) has completed a risk review of Mantel’s Canine Freeze-Dried Plasma (cFDP), a pooled allogeneic canine plasma product intended for the treatment of hypovolemia and control of...
Canine microRNA Biomarkers and Osteosarcoma Diagnostics
The Diagnostic Problem Despite advances in surgery and chemotherapy, survival outcomes for osteosarcoma have changed little in more than 30 years – largely because metastasis is detected too late. Current diagnostics rely on imaging (often after spread has occurred),...
Why DSHEA Reform Must Be a Priority
Why DSHEA Reform Must Be a Priority The recent wave of moringa-related contamination recalls – touching national retail chains and rippling through dozens of contract manufacturers – has forced an uncomfortable question into public view: How was a single tainted...
The 30-Year Consequences of Faulty Supplement Legislation
How a 1994 Law Created Today’s Dietary Supplement Crisis In light of the current moringa contamination recalls affecting national retailers and dozens of downstream manufacturers, many consumers are asking the same question: How did this happen? The answer leads us...
Invisible Outbreak of Contaminated Supplement Ingredients
Contaminated Products Distributed Nationwide How a contaminated Moringa shipment was spread across the U.S. supplement market, and why there were no additional recalls. Sam’s Club announced a recall of its Member’s Mark Super Greens powder in late October 2025 due...
Organic Moringa Powder Recalled for Salmonella Contamination
On November 12, organic moringa powder importer and packager Africa Imports issued a recall notice for its products dating back to June 5. The recall notice was published on the FDA website. Following are details of the recall. Who Issued the Recall Africa Imports...
When Generic Drugs Are Not Equivalent
Fighting for BreathLung transplant patient Hannah Goetz’s life depended on the generic version of a critical drug. It was supposed to be equivalent to the brand-name medication — but the FDA doesn’t always ensure that’s the case.by Megan Rose and Debbie Cenziper,...
Proposed Bill Would Increase Drug Labeling Transparency
Proposed Legislation would Require Generic Drug Labels to Bear Manufacturer, Location, and Key Suppliers ProPublica's RX Inspector tool provides manufacturer location and inspection information for 40k generic drug manufacturersby by Debbie Cenziper, ProPublica,...
FDA Removes Autism Treatments Warning
Chlorine Dioxide, Raw Camel Milk: The FDA No Longer Warns Against These and Other Ineffective Autism Treatments The FDA has taken down a webpage warning about therapies and products making “false claims” of treating autism. It’s part of a series of actions the agency...
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...
Baxter Updates Use Instructions for Volara Ventilators
Baxter Issues Updated Use Instructions for Volara Ventilator Circuits Following Serious Injury Reports Baxter International...
Early Alert: Cook Medical Sizing Catheters
Cook Medical Sizing Catheters Removed Due to Risk of Device Breakage The U.S. Food and Drug Administration (FDA) has issued...
Medline Recalls Angiographic RA Control Syringes
Angiographic Syringe Recall: Medline Removes RA Control Syringes Due to Risk of Disconnection and Air Embolism The U.S....
EU Notified Bodies
Role, Responsibilities, and Strategic Considerations for Medical Device Manufacturers Notified Bodies (NBs) are independent...
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...
FDA Class I Recall for Abiomed Impella Gen 1 Purge Cassettes
Medical Device Alert: Abiomed Impella Purge Cassette Recall (Class I) Abiomed has initiated a Class I recall, the most...
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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