Medical Devices and Pharma
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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 an early alert regarding a potentially serious device issue involving certain sizing catheters manufactured by Cook Medical. Cook Medical has...
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. Food and Drug Administration (FDA) has announced that Medline Industries has issued an Urgent Medical Device Recall involving certain Namic...
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 serious classification issued by the U.S. Food and Drug Administration, for certain Impella purge cassettes and associated pump sets due to a...
Class I Correction for Abiomed Impella Inaccurate Flow Readings
Abiomed Impella RP: FDA Class I Correction for Inaccurate Flow Readings Abiomed has issued an Urgent Medical Device Correction for its Impella RP with SmartAssist and Impella RP Flex with SmartAssist systems due to potential inaccuracies in displayed pump performance...
Merit Medical Dialysis Catheter Recall – Risk of Serious Injury
Merit Medical Removes 16F Dual-Valved Splittable Sheath Introducer Design Defect May Lead to Hemorrhage, Embolization, and Loss of Vascular Access The U.S. Food and Drug Administration (FDA) has identified a Class I recall involving Merit Medical’s 16F Dual-Valved...
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. Food and Drug Administration (FDA) has announced that Medline Industries has issued an Urgent Medical Device Recall involving certain Namic...
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 serious classification issued by the U.S. Food and Drug Administration, for certain Impella purge cassettes and associated pump sets due to a...
Class I Correction for Abiomed Impella Inaccurate Flow Readings
Abiomed Impella RP: FDA Class I Correction for Inaccurate Flow Readings Abiomed has issued an Urgent Medical Device Correction for its Impella RP with SmartAssist and Impella RP Flex with SmartAssist systems due to potential inaccuracies in displayed pump performance...
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...
How to Know if Internet GLP-1 Ads Are Safe to Purchase Online
Ads for GLP‑1 drugs are flooding the internet – here’s how to know if it’s safe to buy them online Websites that sell compounded versions of GLP-1 drugs are not allowed to sell them under the brand names. Michael Siluk/UCG, Universal Images Group via Getty Images...
Blaine Labs Recalls Wound Care Gels for Microbial Contamination
Blaine Labs, Inc Issues Voluntary Nationwide Recall of Wound Care Gel Products Due to Microbial Contamination Potential infection risk for vulnerable patients highlights critical quality system considerations Recall Overview Blaine Labs, Inc. has issued a voluntary...
Adulterated Supplements and the Limits of Post-Market Oversight
FDA Recall of Adulterated Supplements Raises Questions About DSHEA Oversight Lessons from the “Boner Bear” Recall The FDA’s recent recall of several honey-based “sexual enhancement” supplements illustrates a recurring problem in the dietary supplement marketplace:...
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...
Allergy Alert: Silver Moon LP dba Loard’s Ice Cream
Loard’s Ice Cream Recalls Products Due to Undeclared Allergens and Missing Ingredient Labeling Silver Moon LP, doing business as Loard’s Ice Cream of San Leandro, California, has voluntarily recalled all retail-packaged ice cream products due to missing ingredient...
How to Know if Internet GLP-1 Ads Are Safe to Purchase Online
Ads for GLP‑1 drugs are flooding the internet – here’s how to know if it’s safe to buy them online Websites that sell compounded versions of GLP-1 drugs are not allowed to sell them under the brand names. Michael Siluk/UCG, Universal Images Group via Getty Images...
Blaine Labs Recalls Wound Care Gels for Microbial Contamination
Blaine Labs, Inc Issues Voluntary Nationwide Recall of Wound Care Gel Products Due to Microbial Contamination Potential infection risk for vulnerable patients highlights critical quality system considerations Recall Overview Blaine Labs, Inc. has issued a voluntary...
Abbott Hit with $70 Million Verdict from Infant Formula Litigation
Neonatal nutritional product litigationJury findings raise new questions about risk communication, labeling, and regulatory expectations for neonatal nutrition products A Chicago jury has ordered Abbott Laboratories to pay $70 million in damages after finding that its...
FDA Approves First Gene Therapy for Genetic Hearing Loss
FDA Approves First Gene Therapy for Genetic Hearing LossRapid Review and Breakthrough Science Converge in Landmark OTOF...
April 2026 Update for FDA QMSR Inspection Results
April 2026 Update for FDA QMSR Inspection ResultsConfirming the Shift to System-Level, Risk-Based Inspection When FDA’s...
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...
Good Brain Tonic recalled by Liquid Blenz due to botulism risk
Good Brain Tonic Recall: Liquid Blenz Removes Beverage Due to Botulism Risk FDA Issues Nationwide Alert for “Memory and...
Allergy Alert: Silver Moon LP dba Loard’s Ice Cream
Loard’s Ice Cream Recalls Products Due to Undeclared Allergens and Missing Ingredient Labeling Silver Moon LP, doing...
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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