Medline Integrated Arterial Catheters continuously monitor blood pressure. Excess material on the catheter hub that may detach and enter the patient. Read More (external link)...
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On January 20, 2025, President Trump issued an executive memorandum announcing a “regulatory freeze” that pauses all federal rulemaking activities across executive departments and agencies. Key highlights include: No New Rules Proposed or final rules cannot move forward until reviewed and approved by an appointee designated by the President. Exceptions may apply for emergencies or urgent circumstances, such as those with statutory or judicial deadlines, as determined by the Director or Acting Director of the White House’s Office of Management and Budget (OMB). Immediate Withdrawal Any rules submitted to the Federal Register but not yet published, or issued in any manner but not yet...
Continue readingThe FDA is alerting users of diabetes-related medical devices that smartphones connected to diabetes devices may fail to send critical safety alerts. Read More (external link)...
Continue readingBaxter Healthcare is recalling the Life2000 Ventilator System by correction, due to a defective battery charger making the ventilator inoperable. Read More (external link)...
Continue readingJIANGSU JUMAO X-CARE MEDICAL EQUIPMENT CO LTD is recalling certain devices due to incidents of device melting and fire during the use of oxygen concentrators. Read More (external link)...
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Welcome to the Life Sciences Law blog — your resource for legal insights, regulatory developments, and policy trends shaping the life sciences industry today. In this space, we’ll explore how key issues impact FDA-regulated companies as well as the cannabis, hemp, and psychedelics industries. Writing about science and law is what we love to do. We’re not just here tracking headlines; We’re translating them into practical takeaways through a thoughtful perspective. Whether it’s exploring how biotech companies tackle clinical trial design, analyzing the latest developments in compounded GLP-1 regulations, or discussing emerging trends in psychedelics and cannabis, understanding not just what’s happening...
Continue readingBecker and Exacta EDMS are used for draining and monitoring cerebrospinal fluid in the brain. Stopcocks may have cracks or leaks that pose a risk to patients. Read More (external link)...
Continue readingJanuary 31, 2025 — Gerber Products Company is initiating a recall and discontinuation of all batches of GERBER® SOOTHE N CHEW® TEETHING STICKS due to a potential choking hazard for babies and young children Read More (external link)...
Continue readingAlvogen, Inc. is voluntarily recalling one lot of Fentanyl Transdermal System 25 mcg/h transdermal patches to the consumer level. The reason for the recall is that there is a potential that patches could be multi-stacked, adhered one on top of the other, in a single product pouch. This transdermal s Read More (external link)...
Continue readingJanuary 31, 2025– Blue Ridge Beef is recalling 5,700 lbs. of their 2 lb log Natural Mix due to a contamination of Salmonella. Lot # N25/12/31 (Lot numbers are stamped in the clips on the end of the chubs/bags) UPC# 854298001054. Read More (external link)...
Continue readingThis communication is part of the Communications Pilot to Enhance the Medical Device Recall Program Read More (external link)...
Continue readingThis communication is part of the Communications Pilot to Enhance the Medical Device Recall Program Read More (external link)...
Continue readingThis communication is part of the Communications Pilot to Enhance the Medical Device Recall Program Read More (external link)...
Continue readingThis communication is part of the Communications Pilot to Enhance the Medical Device Recall Program Read More (external link)...
Continue readingThis communication is part of the Communications Pilot to Enhance the Medical Device Recall Program Read More (external link)...
Continue readingMercury Medical recalls the Neo-Tee T-Piece Resuscitator due to the controller potentially not delivering the pressure levels needed for effective ventilation. Read More (external link)...
Continue readingJanuary 29, 2025 – United Natural Trading LLC, Edison, NJ, is voluntarily recalling Fresh Direct Dark Chocolate Covered Pretzels due to the presence of an undeclared milk allergen. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction Read More (external link)...
Continue readingStatStrip Hospital Glucose and Ketone Meters provide blood glucose and ketone readings in health care settings. A software issue may transmit inaccurate results to patient records. Read More (external link)...
Continue readingThe FDA is raising awareness about cybersecurity vulnerabilities with Contec CMS8000 and Epsimed MN-120 patient monitors. Read More (external link)...
Continue readingOlympus Corporation has announced a voluntary Advisory Notice for the Forceps/Irrigation Plug (Isolated Type) model MAJ-891 related to the risk of device contamination that may result from improper reprocessing of the MAJ-891 accessory. Read More (external link)...
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