Medical Devices and Pharma
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FDA Early Alert – Hamilton Medical Breathing Circuit Sets
FDA Issues Early Alert for Hamilton Medical Breathing Circuit Sets Following Reports of Serious Injuries The U.S. Food and Drug Administration (FDA) has issued an Early Alert regarding certain Hamilton Medical coaxial breathing circuit sets used with HAMILTON-C1,...
FDA Early Alert for GE HealthCare Infant Resuscitation Systems
FDA Issues Early Alert for GE HealthCare Infant Resuscitation Systems Due to Oxygen Blender Issue Early Alert for GE HealthCare Infant Resuscitation Systems The U.S. Food and Drug Administration (FDA) has issued an Early Alert regarding a potentially high-risk issue...
Major Eye Drop Recall Shows Manufacturing and Inspection Issues
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...
Abiomed Issues Correction for Automated Impella ControllersÂ
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...
FDA Clears First OTC Continuous Glucose Monitor for Children
Regulatory Snapshot Device: Stelo® Glucose Biosensor System (Dexcom, Inc.)Indication: Continuous glucose monitoring for individuals ages 2 years and older who do not use insulin, including children with diabetes managed through oral medications and individuals seeking...
FDA Early Alert for Baxter Pressure Breathing Device
FDA Issues Early Alert for Baxter Volara System Patient Circuits Following Therapy Leakage Concerns The U.S. Food and Drug Administration (FDA) has issued an Early Alert regarding a potentially high-risk issue affecting certain Baxter Volara System patient circuits...
FDA Early Alert – Hamilton Medical Breathing Circuit Sets
FDA Issues Early Alert for Hamilton Medical Breathing Circuit Sets Following Reports of Serious Injuries The U.S. Food and Drug Administration (FDA) has issued an Early Alert regarding certain Hamilton Medical coaxial breathing circuit sets used with HAMILTON-C1,...
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 the distinction between surrogate endpoints and clinical outcomes in drug development The U.S. Food and Drug Administration (FDA) has approved...
Gas Station Drugs: The Regulatory Wild West
Walk into enough gas stations, smoke shops or convenience stores in America and eventually you will encounter a strange modern pharmacy hiding in plain sight. Brightly colored “energy shots.” “Herbal” sexual enhancement pills. Kratom capsules and concentrated...
Warning Letter Cites Serious Deficiencies at Pharma Facility
Serious Sterility and CGMP Deficiencies at ProRx Outsourcing Facility The FDA has issued a significant Warning Letter to ProRx LLC, an FDA-registered outsourcing facility located in Exton, Pennsylvania, citing major violations involving sterile drug compounding...
FDA Cites Data Integrity and OOS Failures at Intas Pharma
FDA Warning Letter: Data Integrity and OOS Failures at Intas Pharmaceuticals Limited The U.S. Food and Drug Administration issued a Warning Letter to Intas Pharmaceuticals Limited citing significant violations of Current Good Manufacturing Practice (CGMP) at its...
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,...
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...
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...
Do Not Blame FDA for Lax Oversight of Dietary SupplementsÂ
A Regulatory System Designed to Fail The recent recalls involving contaminated moringa leaf powder should alarm every company that manufactures, imports, or sells dietary supplements in the United States. They highlight a reality that consumers rarely understand, and...
Has Industry Self-Regulation Been Effective?Â
Has Industry Self-Regulation Been Effective? Supplement industry self-regulation has helped in limited ways, but it has not been sufficient to ensure reliable safety. What has worked Voluntary GMP certifications (e.g., NSF, USP, Informed Choice) A minority of...
FDA Clears First OTC Continuous Glucose Monitor for Children
Regulatory Snapshot Device: Stelo® Glucose Biosensor System (Dexcom, Inc.)Indication: Continuous glucose monitoring for individuals ages 2 years and older who do not use insulin, including children with diabetes managed through oral medications and individuals seeking...
Gas Station Drugs: The Regulatory Wild West
Walk into enough gas stations, smoke shops or convenience stores in America and eventually you will encounter a strange modern pharmacy hiding in plain sight. Brightly colored “energy shots.” “Herbal” sexual enhancement pills. Kratom capsules and concentrated...
Major Eye Drop Recall Shows Manufacturing and Inspection Issues
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...
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...
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...
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...
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....
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)...
Warning Letter to Zoll Medical for Major QMS Violations
Warning Letter to Zoll Medical for Major QMS Violations The U.S. Food and Drug Administration has issued a Warning Letter...
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.
Our goal is to provide organized, clearly written information from regulatory affairs and consumer perspectives.
- Key information from the Food and Drug Administration (FDA), the federal regulatory agency responsible for providing oversight over the industries and assuring the safety and efficacy of their products.
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Perhaps most importantly, we will strive to maintain vigilance over product issues and their impacts. Check back here for consumer news, product alerts, and current litigation.
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