Medical Devices and Pharma
Medical device and pharmaceutical regulatory consulting and health safety informationFDA and global regulatory affairs, consumer health, and professional development
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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...
SonarMed Inc Recalls Airway Acoustic Sensors
Urgent Class I Recall Notice SonarMed Inc. has issued a Class I recall for its Airway acoustic sensors due to a critical issue that could lead to serious health consequences for patients. The U.S. Food and Drug Administration (FDA) has identified this as the most...
The IMDRF: International Regulators
The International Medical Device Regulators Forum (IMDRF) plays a pivotal role in shaping global regulatory approaches and standards for medical devices, enhancing safety and innovation across international borders.The International Medical Device Regulators Forum...
FDA Submission and Approval Processes for 510(k)s
Learn how the FDA's 510(k) premarket notification system facilitates the introduction of new medical devices to the market, ensuring safety and compliance.Partner with us to navigate the complexities of the FDA approval process efficiently.The FDA's 510(k) process is...
DeRoyal Industries, Inc. Recalls Tracecarts
Urgent Class I Recall Notice DeRoyal Industries, Inc. has issued an urgent recall notice for certain Tracecarts containing 16FR Urine Meter Foley under recall by Nurse Assist. Identified by the FDA as a Class I recall, the most serious type, the use of these devices...
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...
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Original FDA Safety Warning for China-made Syringes
In an announcement dated November 30, 2023, the U.S. Food and Drug Administration (FDA) issued a notice regarding the evaluation of potential device failures associated with plastic syringes manufactured in China. The FDA is actively collecting and analyzing data to...
AvKARE Recalls Atovaquone Oral Suspension
AvKARE Recalls Atovaquone Oral Suspension AvKARE, LLC has issued a voluntary recall of lot # AW0221A of Atovaquone Oral Suspension, USP 750mg/5mL due to potential Bacillus cereus contamination found during stability testing at a third-party lab. The affected...
FDA Warns of Risks with OTC Pain Relief Products
The U.S. Food and Drug Administration (FDA) has issued a stern warning to consumers regarding the use of certain over-the-counter analgesic (pain relief) products intended for topical use before, during, or after various cosmetic procedures like microdermabrasion,...
Urgent Recall Alert for Methocarbamol Injection by Eugia US LLC
Attention Consumers, Healthcare Providers, and Distributors: Eugia US LLC, formerly known as AuroMedics Pharma LLC, announced a voluntary recall on March 28, 2024 of lot number 3MC23011 of Methocarbamol Injection, USP 1000 mg/10 mL (100mg/mL) 10mL Single Dose Vial....
Global Medical Device Reporting and Vigilance
International Medical Device Reporting Medical Device Reporting and Vigilance in the EU and Globally Timely and...
U.S. Medical Device Reporting
U.S. FDA Medical Device Reporting What is 21 CFR Part 803 (Medical Device Reporting)? This regulation establishes...
Device Recall Alert: Edwards Lifesciences Arterial Cannula
Edwards Lifesciences Arterial CannulaSource: FDAEdwards Lifesciences Recalls Arterial Cannulae Over Risk of Exposed Wire...
Device Recall: ZOLL AutoPulse NXT Resuscitation System
Urgent Class I Medical Device Recall ZOLL Circulation, Inc. has issued a Class I recall of its AutoPulse NXT Resuscitation...
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...
Urgent Recall of Codman Disposable Perforators
Urgent Class I Medical Device Recall Integra LifeSciences has issued an urgent recall of specific Codman Disposable...
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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