Medical Devices and Pharma
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Urgent Recall Alert for BD Alaris Infusion Sets
Class I Recall (Correction) The FDA has issued an early alert to healthcare providers and patients regarding a performance issue affecting BD Alaris Pump Module model 8100, used with specific compatible infusion sets. BD, through its subsidiary CareFusion, has...
Recall Alert: AirLife/Vyaire Infant Breathing Systems
Class I Recall AirLife and manufacturer Vyaire are recalling specific Infant Heated Wire Circuits due to the risk that accessory adapters may disconnect during use, especially once the system reaches operating temperature. This could lead to serious injury or death,...
Avanos Recalls Ballard Closed Suction Systems
May result in non-sterile devices Avanos Medical, Inc. is recalling its Ballard Closed Suction Systems after identifying a failure in the sterilization process, which may result in non-sterile devices. Use of these products could lead to serious health risks,...
FDA Alert: Abiomed Impella Blood Pump Controller
Abiomed Impella blood pump controllers Controller May Fail to Detect Device Abiomed has issued an urgent safety notice for its Automated Impella Controller (AIC) due to a potentially serious issue where the system may fail to detect the Impella blood pump when...
Alert: Ventilator Systems Risk in Neonatal Tidal Volume Delivery
Maquet Servo Ventilator SystemsSource: FDAUrgent Class I Medical Device Correction Maquet Critical Care AB, a subsidiary of Getinge, has issued an urgent correction notice regarding its Servo Ventilator Systems (Servo-u, Servo-n, and Servo-u MR). This correction does...
FDA Cracks Down on Insightra Medical
Warning Letter Cites a Number of Serious Violations In a scathing warning letter, the FDA has cited Insightra Medical, Inc. for widespread regulatory violations involving its Intra-Aortic Balloon Pump (IABP) Catheter Kit—a device used in critical cardiovascular...
Mechanical Circulatory Support (MCS) Devices
Overview of MCS Devices Mechanical Circulatory Support (MCS) devices have transformed the landscape of advanced heart failure treatment. From temporary stabilization in cardiogenic shock to long-term support as destination therapy, these technologies bridge critical...
Recall Alert: AirLife/Vyaire Infant Breathing Systems
Class I Recall AirLife and manufacturer Vyaire are recalling specific Infant Heated Wire Circuits due to the risk that accessory adapters may disconnect during use, especially once the system reaches operating temperature. This could lead to serious injury or death,...
FDA Grants Accelerated Approval to Multiple Myeloma Treatment
For hard-to-treat multiple myeloma On July 2, 2025, the FDA granted accelerated approval to linvoseltamab-gcpt (brand name: Lynozyfic) for adults with relapsed or refractory multiple myeloma who have received at least four prior therapies, including: A proteasome...
FDA Approves Alhemo for Patients with Hemophilia A or B
For Patients with Hemophilia A or B with Inhibitors The FDA has approved Alhemo (concizumab-mtci) for routine prophylaxis to prevent or reduce bleeding episodes in patients aged 12 and older with: Hemophilia A with factor VIII inhibitors, or Hemophilia B with factor...
First-in-Class Non-Opioid Pain Reliever: Journavx
A new non-opioid pain treatment option On January 30, 2025, the FDA granted priority review for Journavx (suzetrigine) – a first-in-class, non-opioid analgesic for treating moderate to severe acute pain in adults. How It Works Journavx targets sodium channels in the...
FDA Approves DATROWAY® Breast Cancer Treatment
A new breast cancer treatment option The United States Food and Drug Administration (FDA) approved DATROWAY® (datopotamab deruxtecan-dlnk) on January 17, 2025, for adults with hormone receptor-positive (HR+), HER2-negative breast cancer that is unresectable or...
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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...
Why Not Natural Organic Moringa Capsules Recalled
Why Not Natural Organic Moringa Capsules Recalled Over Possible Salmonella Contamination Editor's Note: This January 28 recall was the third recent moringa-root product recall, following the Sam's Super Greens recall in November and the Live it Up Super Greens recall...
Live it Up Super Greens Recalled Over Salmonella Contamination
Live it Up Super Greens Recalled Over Possible Salmonella Contamination Editor’s Note: The original recall notice was issued on January 15, 2026 and is summarized here for reference purposes. Superfoods, Inc., doing business as Live it Up (New York, NY), has issued a...
FDA Testosterone Panel Sparks Concern
Concerns Over Sudden Regulatory Shift The FDA’s December 2025 expert panel has recommended sweeping changes to testosterone regulation – a sharp departure from the agency’s long-standing cautionary stance for the hormone. The panel urged the FDA to broaden...
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...
FDA Recalls “Sexual Enhancement” Supplements
FDA Recall Highlights Ongoing Risks of Adulterated “Sexual Enhancement” Supplements Pure Vitamins and Natural Supplements,...
FDA’s AEMS: Real-Time Drug and Device Safety Monitoring
FDA’s AEMS: The Beginning of Real-Time Drug and Device Safety MonitoringThe U.S. Food and Drug Administration has launched...
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...
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...
FDA Streamlines Biosimilar Development to Reduce Drug Costs
FDA Moves to Streamline Biosimilar Development and Reduce Drug Costs The U.S. Food and Drug Administration (FDA) has...
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.
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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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