Medical Devices and Pharma
Medical device and pharmaceutical regulatory consulting and health safety informationFDA and global regulatory affairs, consumer health, and professional development
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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...
Sterile Drug Manufacturing Violations at Daewoo Pharmaceutical
FDA Cracks Down on Sterile Drug Manufacturing Violations The U.S. Food and Drug Administration (FDA) has issued a warning letter to Daewoo Pharmaceutical Co., Ltd. in Busan, South Korea, citing serious and widespread violations of current Good Manufacturing Practices...
What Are Early Recall Alerts?
Recall Communication “Early Alerts” Note: This summary is based on an FDA communication attributed to Michelle Tarver, M.D., Ph.D., director of the Center for Devices and Radiological Health (CDRH). In November 2024 the U.S. Food and Drug Administration’s Center for...
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...
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...
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...
Sterile Drug Manufacturing Violations at Daewoo Pharmaceutical
FDA Cracks Down on Sterile Drug Manufacturing Violations The U.S. Food and Drug Administration (FDA) has issued a warning letter to Daewoo Pharmaceutical Co., Ltd. in Busan, South Korea, citing serious and widespread violations of current Good Manufacturing Practices...
The FDA Orphan Drug Program
Incentives for Rare Disease Drug Development The FDA’s Orphan Drug Program was established to encourage the development of drugs for rare diseases that affect fewer than 200,000 people in the U.S. Because these diseases often lack market incentives due to small...
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...
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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...
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...
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...
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...
Nivolumab Combination Therapy for Advanced Hodgkin Lymphoma
FDA Approves Nivolumab Combination Therapy for Advanced Hodgkin Lymphoma On March 20, 2026, the U.S. Food and Drug...
When a Small Process Failure Becomes a Patient Safety Event
What the Erbe Cryoprobe Alert Teaches Us About Modern Device Quality The FDA’s recent Early Alert regarding flexible...
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...
EPA Proposes Rollback of EtO Sterilization Emissions Limits
EPA Proposes Rollback of Ethylene Oxide Sterilization Emissions LimitsThe U.S. Environmental Protection Agency has proposed...
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.
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