Medical Devices and Pharma
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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 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
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...
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 to ZOLL Medical Corporation citing significant Quality System Regulation (QSR) violations involving corrective and preventive action (CAPA),...
Abiomed Issues Correction for Automated Impella Controllers
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 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...
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....
Major Manufacturers of Animal Orthopedic Devices
Manufacturers of Common Veterinary Orthopedic Product Families The veterinary orthopedic device market includes a mix of dedicated veterinary implant manufacturers and veterinary divisions of established human orthopedic companies. Product portfolios vary widely, but...
Animal Orthopedics Device Types
Major Categories of Animal Orthopedic Devices Animal orthopedic medicine has evolved into a sophisticated surgical discipline supported by highly engineered implant systems and instrumentation platforms. What was once limited to basic fracture repair now includes...
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...
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...
Four Moringa-Linked Salmonella Events in Four Months
Four Moringa-Linked Salmonella Events in Four Months: The Timeline That Should Not Exist An MDP Consumer and Industry Brief A single recall can be dismissed as a one-time failure. Two recalls in the same ingredient category raise questions. But when moringa-based...
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...
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...
Infant Formula Recalled after Reports of Botulism
Three Infants Hospitalized; Nationwide Recall Initiated Nara Organics has voluntarily recalled all lots of its powdered infant formula currently on the U.S. market following reports of three cases of infant botulism in infants who reportedly consumed the product. ...
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...
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...
Abiomed Issues Correction for Automated Impella Controllers
Hardware Updates Required to Address Potential Loss of Hemodynamic Support Abiomed has issued a correction for certain...
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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