Devices

Medline Class 1 Recall on Malfunctioning Beds

Medline has recalled (Class 1 device correction) certain Medline homecare beds, warning that continued use without updated instructions could result in serious injury or death. The action affects multiple models of Medline Basic and Medlite Homecare Beds. An FDA recall notice says Medline has received reports of pendants overheating, sparking, melting, smoking, and catching fire, which have led to 12 injuries and one death associated with those incidents.

Medline also warned of a separate entrapment hazard when non-Medline accessories are used with the beds. According to FDA, incompatible accessories or user error involving the pendant can cause unintended bed movement, potentially trapping patients between the bed and attached equipment — a risk that may be heightened in home settings where monitoring is limited. The company has reported two additional injuries and one death tied to accessory-related entrapment. The agency is advising customers to keep affected beds unplugged except when making necessary adjustments, avoid exceeding weight limits, inspect for obstructions or damaged wiring, and use only approved Medline side rails and accessories.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome