Medical Devices and Pharma
Medical device and pharmaceutical regulatory consulting and health safety informationHeadlines
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...
GE HealthCare Anesthesia Systems Recall Due to Ventilation Risk
GE Carestation Anesthesia Systems GE HealthCare has issued a high-priority correction for certain Carestation anesthesia systems due to a potentially life-threatening risk when used in Volume Control Ventilation (VCV) mode. Affected Devices Carestation 620, 650, 650c...
FDA Alert: Baxter Recalls Spectrum Infusion Pumps
Baxter Spectrum Infusion Pump Alert Date: July 2025Device: Sigma Spectrum Infusion System (V6 and V8 Platforms)Manufacturer: Baxter HealthcareIssue Type: Urgent Medical Device RecallFDA Status: High-risk; active monitoring in progress The FDA has issued an early alert...
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...
GE HealthCare Anesthesia Systems Recall Due to Ventilation Risk
GE Carestation Anesthesia Systems GE HealthCare has issued a high-priority correction for certain Carestation anesthesia systems due to a potentially life-threatening risk when used in Volume Control Ventilation (VCV) mode. Affected Devices Carestation 620, 650, 650c...
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...
The Role of a Regulatory Professional
510(k) Submissions The New QSMR Regulatory Intelligence RIM Systems Regulatory Competencies Regulatory and Quality Role of Regulatory Professionals: Core Responsibilities Regulatory professionals play a critical role in ensuring that medical devices and pharmaceutical...
Urgent Recall: Dr. Reddy’s Levetiracetam Injection
What You Need to Know Dr. Reddy’s Laboratories has issued an urgent recall for one batch (Lot No: A1540076) of Levetiracetam in 0.75% Sodium Chloride Injection, 1,000 mg/100 mL due to a serious labeling error. The infusion bag is incorrectly labeled as Levetiracetam...
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),...
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...
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...
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...
Testosterone Regulation Takes a Sharp Turn
Why FDA’s December Panel Raises Red Flags Regulatory Analysis The FDA’s regulation of testosterone therapy has long been a model of cautious, evidence-based policymaking. For more than a decade, the agency maintained a consistent position: testosterone was approved...
How U.S. Testosterone Regulation Reached a Crossroads
How U.S. Testosterone Regulation Reached a Crossroads The FDA’s approach to testosterone therapy has undergone one of the most unusual and dramatic evolutions in modern drug regulation. What began as a cautious, evidence-driven posture in 2014 has, by late 2025,...
Latest Posts
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...
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 Approves First Generic Drug for Equine Cushing’s Disease
An important step in expanding treatment access for horses with PPID The U.S. Food and Drug Administration has approved Zygolide® (pergolide tablets), the first FDA-approved generic drug for the control of clinical signs associated with Pituitary Pars Intermedia...
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