Medical Devices and Pharma
Medical device and pharmaceutical regulatory consulting and health safety informationHeadlines
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...
Urgent Recall of Codman Disposable Perforators
Urgent Class I Medical Device Recall Integra LifeSciences has issued an urgent recall of specific Codman Disposable Perforators and Craniotomy Kits due to a serious manufacturing defect that may lead to device disassembly during neurosurgical procedures. The FDA has...
FDA Cracks Down on Illegally Marketed 7-OH Products
Unapproved drugs sold online and in retail locations Yesterday the U.S. Food and Drug Administration (FDA) issued seven warning letters to companies marketing products that contain 7-hydroxymitragynine (7-OH) — a powerful and potentially dangerous opioid-like...
Why You Should Start Your QMSR Transition Now
Start Preparing for the QMSR – Now The FDA’s Quality Management System Regulation (QMSR) will officially replace the long-standing Quality System Regulation (QSR) in February 2026. For many manufacturers, that may sound like plenty of time. But here’s the truth: You...
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...
Global Medical Device Reporting and Vigilance
International Medical Device Reporting Medical Device Reporting and Vigilance in the EU and Globally Timely and transparent reporting of medical device incidents is critical to protecting public health and ensuring continued confidence in healthcare technologies....
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...
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 “PreCheck” Program to Boost U.S. Drug Manufacturing
FDA Announces New PreCheck Drug Manufacturing Program The U.S. Food and Drug Administration (FDA) has announced the launch of FDA PreCheck, a groundbreaking new program designed to strengthen America’s domestic pharmaceutical supply chain by streamlining the...
FDA Cracks Down on Illegally Marketed 7-OH Products
Unapproved drugs sold online and in retail locations Yesterday the U.S. Food and Drug Administration (FDA) issued seven warning letters to companies marketing products that contain 7-hydroxymitragynine (7-OH) — a powerful and potentially dangerous opioid-like...
FDA Approves First Generic Drug for Equine Cushing’s Disease
An important step in expanding treatment access for horses with PPID The U.S. Food and Drug Administration has approved Zygolide® (pergolide tablets), the first FDA-approved generic drug for the control of clinical signs associated with Pituitary Pars Intermedia...
FDA Approves First Oral Treatment for Canine Lymphoma
Approval Granted With Minor Use/Major Species (MUMS) Pathway The U.S. Food and Drug Administration has granted full approval to Laverdia® (verdinexor tablets), the first FDA-approved oral treatment for lymphoma in dogs. Canine lymphoma is a cancer of the lymph nodes...
FDA Grants Full Approval for Canine Epilepsy Drug
Approval Granted After Expanded Conditional Pathway The U.S. Food and Drug Administration has granted full approval to KBroVet® (potassium bromide chewable tablets) for the control of seizures in dogs diagnosed with idiopathic epilepsy, a chronic seizure disorder with...
FDA Advisory for Contaminated Raaw Energy Dog Food
The U.S. Food and Drug Administration (FDA) has issued a public advisory warning pet owners not to feed eight identified lots of Raaw Energy dog food after testing confirmed contamination with multiple pathogenic bacteria, including Listeria monocytogenes, Salmonella,...
Moringa and the “Invisible Outbreak” Problem
Moringa and the “Invisible Outbreak” Problem in Supplements An MDP Consumer and Industry Brief Most Americans assume dietary supplements are monitored for safety in the same way as conventional foods or pharmaceutical products. But many supplement contamination events...
Rosabella Moringa Capsules Potential Salmonella Contamination
Rosabella Moringa Capsules Recalled Over Possible Salmonella Contamination Editor's Note: This February 13 recall is the latest moringa-root product recall, following the Sam's Super Greens recall in November, the Live it Up Super Greens recall on January 15, and the...
Why Not Natural Organic Moringa Capsules Recalled
Why Not Natural Organic Moringa Capsules Recalled Over Possible Salmonella Contamination Editor's Note: This January 28 recall was the third recent moringa-root product recall, following the Sam's Super Greens recall in November and the Live it Up Super Greens recall...
Live it Up Super Greens Recalled Over Salmonella Contamination
Live it Up Super Greens Recalled Over Possible Salmonella Contamination Editor’s Note: The original recall notice was issued on January 15, 2026 and is summarized here for reference purposes. Superfoods, Inc., doing business as Live it Up (New York, NY), has issued a...
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...
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...
Latest Posts
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 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...
Implications of the New Federal Vaccine Schedule for Children
The New Federal Vaccine Schedule for Children: What Changed and What Are the Implications?Authors: Jennifer Kates and Josh Michaud, KFF This story was originally published by KFF.As widely expected, and following a recent Presidential memorandum, the Department of...
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,...
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...
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,...
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