Medical Device and Pharmaceutical News
The latest information of interest to regulated industry. Bookmark this page to have a quick review for
-
- FDA enforcement news
- Regulatory updates
- Innovative products
- Compliance information, and
- Other industry headlines.
And do not forget to check our pages for consumer safety information and regulatory services.
Product Safety Agency Demands Patients’ ER Hospital Records
Trump Administration Demands Hospitals Share Emergency Room Records
Moringa Capsules Recalled for Potential Salmonella Contamination
Zen Principle Recalls Moringa Capsules After FDA Detects Salmonella in Raw Ingredient Relay Peak Research LLC, doing business as Zen Principle Naturals, has voluntarily recalled one lot of its Zen Principle® Moringa Capsules after learning that the raw moringa leaf...
Eight Months of Moringa Salmonella Outbreaks
Recurring Salmonella Outbreaks Raise Questions About Supplement Oversight Since November 2025, the U.S. Food and Drug Administration has investigated and coordinated multiple recalls involving moringa dietary supplements contaminated with Salmonella. What initially...
FDA Closes Moringa Salmonella Outbreak Investigation
The U.S. Food and Drug Administration and the Centers for Disease Control and Prevention have concluded their investigation into a multistate Salmonella Typhimurium outbreak linked to MOGO-brand moringa powder capsules distributed by MOGO Moringa LLC of St. Louis,...
FDA Early Alert for Baxter Intravascular Administration Sets
Healthcare facilities are instructed to immediately stop using affected IV solution sets while FDA evaluates the potentially high-risk device issueThe U.S. Food and Drug Administration (FDA) has issued an Early Alert regarding certain Baxter Duo-Vent Solution Sets...
Why the Sudden Focus on Testosterone?
New Military Screening Program Raises Questions About Science, Strategy and TransparencyThe Trump administration's decision to begin annual testosterone screening for active-duty and reserve service members age 30 and older has generated headlines and a growing number...
Class I Recall for Bolton Medical RelayPro Thoracic Stent Graft
FDA Issues Class I Recall for RelayPro Thoracic Stent Graft Following Three Patient DeathsDeployment failure during aortic repair may require emergency open surgery The U.S. Food and Drug Administration (FDA) has issued a Class I recall for certain RelayPro Thoracic...
Arrow Corrects Kits With Recalled Injectable Medications
FDA Classifies Field Correction As Class I Recall Due to Risk of Serious Injury The U.S. Food and Drug Administration (FDA) has classified a correction issued by Arrow International, a subsidiary of Teleflex, as a Class I recall after certain convenience kits were...
Casgevy Gene Therapy Expanded to 2-Year-Old Children
FDA Expands Casgevy Gene Therapy Approval to Children as Young as 2 with Sickle Cell DiseaseFirst CRISPR-based gene therapy approved for young children with sickle cell disease The U.S. Food and Drug Administration (FDA) has approved an expanded indication for Casgevy...
FDA Issues Early Alert for Resmed Astral Ventilators
Resmed VentilatorPatients should continue using devices unless instructed otherwise by their healthcare provider The U.S. Food and Drug Administration (FDA) has issued an Early Alert regarding a potentially high-risk issue affecting certain Resmed Astral 100 and...