Medical Devices and Pharma
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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...
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...
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 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...
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 Pathway in Stroke Recovery A company behind one of the world’s most closely watched neurorehabilitation technologies is preparing for a major new...
FDA Warning Letter Cites Systemic Aseptic Manufacturing Failures
Medline Warning Letter Signals Systemic Quality Failures in Cardiovascular Device Manufacturing The FDA has issued a Warning Letter to Medline Industries (NAMIC Division) following a December 2025 inspection, identifying significant Quality System Regulation (QSR)...
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 Therapy The FDA has approved Otarmeni (lunsotogene parvec-cwha), the first gene therapy for a form of inherited hearing loss caused by mutations in...
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...
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...
FDA Approves First Generic for Bovine Respiratory Disease
nixiFLOR, the first generic version of Resflor GOLD The U.S. Food and Drug Administration has approved nixiFLOR, an injectable solution combining florfenicol and flunixin meglumine, for the treatment of bovine respiratory disease (BRD) and the control of...
FDA Approves Drug to Delay Canine Congestive Heart Failure
Vetmedin is the first drug to go from an expanded conditional approval to fully approved The U.S. Food and Drug Administration has fully approved a new use for Vetmedin (pimobendan) chewable tablets, making it the first drug officially recognized to delay the onset of...
FDA Completes Risk Review of Canine Freeze-Dried Plasma
Freeze-Dried Plasma for Emergency Use in Dogs The U.S. Food and Drug Administration (FDA) has completed a risk review of Mantel’s Canine Freeze-Dried Plasma (cFDP), a pooled allogeneic canine plasma product intended for the treatment of hypovolemia and control of...
Canine microRNA Biomarkers and Osteosarcoma Diagnostics
The Diagnostic Problem Despite advances in surgery and chemotherapy, survival outcomes for osteosarcoma have changed little in more than 30 years – largely because metastasis is detected too late. Current diagnostics rely on imaging (often after spread has occurred),...
Why DSHEA Reform Must Be a Priority
Why DSHEA Reform Must Be a Priority The recent wave of moringa-related contamination recalls – touching national retail chains and rippling through dozens of contract manufacturers – has forced an uncomfortable question into public view: How was a single tainted...
The 30-Year Consequences of Faulty Supplement Legislation
How a 1994 Law Created Today’s Dietary Supplement Crisis In light of the current moringa contamination recalls affecting national retailers and dozens of downstream manufacturers, many consumers are asking the same question: How did this happen? The answer leads us...
Invisible Outbreak of Contaminated Supplement Ingredients
Contaminated Products Distributed Nationwide How a contaminated Moringa shipment was spread across the U.S. supplement market, and why there were no additional recalls. Sam’s Club announced a recall of its Member’s Mark Super Greens powder in late October 2025 due...
Organic Moringa Powder Recalled for Salmonella Contamination
On November 12, organic moringa powder importer and packager Africa Imports issued a recall notice for its products dating back to June 5. The recall notice was published on the FDA website. Following are details of the recall. Who Issued the Recall Africa Imports...
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 Focus” Drink Liquid Blenz Corp. has issued a nationwide recall of its Good Brain Tonic beverage due to the potential risk of botulism, a rare but...
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...
Abiomed Issues Correction for Automated Impella Controllers
Hardware Updates Required to Address Potential Loss of Hemodynamic Support Abiomed has issued a correction for certain...
Infant Formula Recalled after Reports of Botulism
Three Infants Hospitalized; Nationwide Recall Initiated Nara Organics has voluntarily recalled all lots of its powdered...
FDA Clears First OTC Continuous Glucose Monitor for Children
Regulatory Snapshot Device: Stelo® Glucose Biosensor System (Dexcom, Inc.)Indication: Continuous glucose monitoring for...
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...
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...
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...
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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