Medical Devices and Pharma
Medical device and pharmaceutical regulatory consulting and health safety informationFDA and global regulatory affairs, consumer health, and professional development
Expert guidance for industry professionals and clear, reliable information for patients and consumers
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...
Class I Correction for Homecare Bed Fire and Entrapment Risks
Medline Homecare Beds: FDA Class I Correction for Fire and Entrapment Risks Medline Industries has issued a critical safety correction involving multiple models of homecare beds following reports of overheating components, electrical hazards, and patient entrapment...
FDA Flags High-Risk Issue with Erbe Flexible Cryoprobes
FDA Flags High-Risk Issue with Erbe Flexible Cryoprobes The FDA’s Center for Devices and Radiological Health (CDRH) has issued an Early Alert regarding a potentially high-risk issue involving certain flexible cryoprobes manufactured by Erbe USA. Issue Overview Erbe...
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...
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...
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:...
When Randomized Trials Are Not Possible
When Randomized Trials Are Not Possible: How Real-World Evidence Is Shaping FDA Drug Approvals The U.S. Food and Drug Administration’s recent approval of leucovorin (Wellcovorin) for cerebral folate transport deficiency caused by FOLR1 gene variants highlights an...
FDA Approves Cerebral Folate Transport Deficiency Treatment
FDA Approves First Treatment for Cerebral Folate Transport Deficiency The U.S. Food and Drug Administration (FDA) has approved an expanded use of Wellcovorin (leucovorin calcium) tablets to treat patients with cerebral folate deficiency caused by variants in the...
FDA Program to Accelerate U.S. Pharmaceutical Manufacturing
FDA Launches “PreCheck” Pilot Program to Accelerate U.S. Pharmaceutical Manufacturing The U.S. Food and Drug Administration has launched a new pilot initiative aimed at strengthening domestic pharmaceutical manufacturing and improving regulatory predictability for...
Canine Osteosarcoma Immunotherapy and Human Research
Osteosarcoma Osteosarcoma is a devastating bone cancer with limited treatment progress over decades. In humans, it remains rare but deadly – striking roughly 1,000 Americans each year, often children and adolescents. It is tragically common in dogs, with an estimated...
No Results Found
The page you requested could not be found. Try refining your search, or use the navigation above to locate the post.
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...
Class I Correction for Homecare Bed Fire and Entrapment Risks
Medline Homecare Beds: FDA Class I Correction for Fire and Entrapment Risks Medline Industries has issued a critical safety correction involving multiple models of homecare beds following reports of overheating components, electrical hazards, and patient entrapment...
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:...
Tippy Toes Apple Pear Banana Baby Food Recalled
Baby Food Recalled for Elevated Patulin Levels Recall Date: February 13, 2026Company: IF Copack LLC d.b.a. Initiative FoodsBrand: Tippy ToesProduct Type: Baby Food Fruit PuréeHazard: Elevated levels of patulin (a mycotoxin) Initiative Foods has issued a voluntary...
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...
FDA-Approved Vivistim: A New Pathway in Stroke Recovery
Vivistim implantable vagus nerve stimulator. Source: Vivistim.com.FDA-Approved Vagus Nerve Stimulation Device Opens a New...
FDA Approves First Veterinary Amlodipine for Feline Hypertension
The U.S. Food and Drug Administration has approved Amodip (amlodipine besylate) chewable tablets for the control of...
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...
FDA Warning Letter Cites Systemic Aseptic Manufacturing Failures
Medline Warning Letter Signals Systemic Quality Failures in Cardiovascular Device Manufacturing The FDA has issued a...
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...
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.
- Regulatory services for compliance, market access, and crisis management
- Information about innovation, including new products cleared for use in the U.S. market.
- News stories with topics ranging from product issues to market trends.
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.
Medical Devices
Pharma