Medical Devices and Pharma
Medical device and pharmaceutical regulatory consulting and health safety informationFDA and global regulatory affairs, consumer health, and professional development
Expert guidance for industry professionals and clear, reliable information for patients and consumers
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Medos International Recalls CEREBASE DA Guide Sheath
Urgent Class I Recall Notice Medos International Sàrl has issued an urgent recall for the Cerenovus CEREBASE DA Guide Sheath, a neurovascular catheter commonly used in procedures requiring precise navigation and access to blood vessels in the brain. The recall was...
Asensus Surgical Inc Issues Recall for Senhance Surgical System
Class I Recall Notice Asensus Surgical Inc. has announced a recall for its Senhance Surgical System due to malfunctions leading to unintended movement of the robotically-assisted surgical device. Device Use The Senhance Surgical System is a vital tool utilized in...
Datex-Ohmeda Issues Field Correction for EVair Air Compressors
Urgent Class I Recall Notice Datex-Ohmeda Inc. has announced a field correction for its EVair and Jun-air compressors, optional ventilator accessories designed to provide an alternative source of airflow for patient support in clinical settings where wall air is...
Differences between BiPAP and CPAP
What Are the Differences between BiPAP and CPAP Machines? BiPAP (Bilevel Positive Airway Pressure) and CPAP (Continuous Positive Airway Pressure) machines are both commonly used to treat sleep apnea, a condition where breathing repeatedly stops and starts during...
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FDA Announces Recall of GE Nuclear Medicine Systems
1200-pound Devices Could Fall on Patients On February 15, the FDA issued a statement announcing a recall of certain nuclear medicine systems manufactured by GE Healthcare. The recall involves the 600/800 Series nuclear medicine systems, which are used to diagnose and...
FDA Information – Conveniently Organized and Accessible
Quickly find the FDA information you need Conveniently organized FDA information. The U.S. Food and Drug Administration (FDA) provides a wealth of information for consumers and industry stakeholders. The problem is, it can be difficult to navigate to the information...
Hospira Recalls Antibiotic for Presence of Glass Particles
Hospira, Inc., a division of Pfizer, announced a Class I recall of its Vancomycin Injection product due to visible glass particles that were identified in one vial of the drug. The recall involves lot 33045BA of Vancomycin Hydrochloride Injection USP 1.5g single dose...
Three Companies Recall Blood Pressure Medication
All recalled products had unacceptable levels of nitrosamines Three pharmaceutical manufacturers have recalled batches of the blood pressure drug quinapril this year for exceeding safe levels of nitrosamines. Luprin Pharmaceuticals, Aurobindo Pharma USA, and Pfizer...
Formaldehyde in Hair Smoothing Products: Know the Risks
Know the Risks Before You Straighten Thinking of straightening or smoothing your hair? Many salon hair treatments release...
FDA: Do Not Use OTC Products to Remove Moles or Skin Tags
FDA: Do Not Use OTC Products to Remove Moles or Skin Tags Thinking about removing a mole, skin tag, or other skin lesion at...
FDA Alert: Baxter Recalls Spectrum Infusion Pumps
Baxter Spectrum Infusion Pump Alert Date: July 2025Device: Sigma Spectrum Infusion System (V6 and V8...
Human Factors Engineering
Human Factors Engineering Human Factors Engineering (HFE) is critical for medical device safety and regulatory compliance,...
Orthopedics Industry Consolidation
Consolidation in the Implantable Orthopedics Industry: A Historical Perspective Early Growth and Initial Consolidation...
How Unsafe Medical Devices Can Slip Through the Cracks
Healthcare professionals and the device industry share responsibility for timely adverse event reportingGlobal device...
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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