Tag: mortality risks

FDA issues Class I recall for Philips BiPAP ventilators

Editor's Note Philips Respironics BiPAP A30, A40, and V30 Auto ventilators are subject to a Class 1 recall—the US Food and Drug Administration’s (FDA’s) most severe category indicating risk of serious injury or death—due to the risk for a failure in the Ventilator Inoperative alarm, which can cause therapy interruption…

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By: Matt Danford
August 5, 2025
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FDA designates Class I recall for disposable surgical stapler cartridge correction

Editor's Note The US Food and Drug Administration (FDA) has designated the recall of Ethicon Endo-Surgery, LLC’s Endopath Echelon Vascular White Reload for Advanced Placement Tip a Class I, the most severe category indicating risk of serious injury or death. As detailed in the agency’s July 25 announcement,  the recall…

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By: Matt Danford
July 28, 2025
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FDA designates Class I recall for mobile lift component

Editor's Note The US Food and Drug Administration (FDA) has designated Baxter’s recall of the Q-Link 13 mobile lift component a Class I, the most severe category indicating risk of serious injury or death. As detailed in the agency’s July 23 announcement, the optional component connects to sling bars on…

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By: Matt Danford
July 24, 2025
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FDA designates Class 1 recalls for closed suction systems, infant heated wire circuits, pediatric emergency tape

Editor's Note Recent recalls of the Ballard Closed Suction Systems from Avanos Medical Inc., Infant Heated Wire Circuits from AirLife/Vyaire, and Broselow Pediatric Emergency Rainbow Tape from AirLife have been designated as Class 1, the US Food and Drug Administration’s (FDA’s) most severe category indicating risk of serious injury or…

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By: Matt Danford
July 10, 2025
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Recent FDA Class 1 recall designations include anesthesia systems, aortic root cannula

Editor's Note The US Food and Drug Administration (FDA) has designated recent medical device recalls involving GE Healthcare’s Carestation anesthesia system, Medtronic aortic root cannula systems, Zoll Circulation’s AutoPulse NXT Resuscitation System, and Medtronic’s Bravo CF Capsule Delivery Devices as Class 1, the most severe category indicating serious risk of…

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By: Matt Danford
June 25, 2025
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FDA designates Class 1 recalls for intraoperative positioning guidewires, infusion pumps, dialysate

Editor's Note Centerline Biomedical’s recall of IOPS Guidewire ATW-2,  Zyno Medical’s recall of Z-800 series infusion pumps, and Nipro’s recall of MedicaLyte Liquid Bycarbonate Concentrate have been designated by the US Food and Drug Administration (FDA) as Class 1, the most serious designation indicating risk of severe injury or death.…

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By: Matt Danford
June 17, 2025
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Study: Simple hysterectomy survival comparable to more radical procedures in early cervical cancer

JAMA (healthcare publication) Network logo

Editor's Note Simple hysterectomy provides similar long-term survival outcomes to modified radical or radical hysterectomy for patients with low-risk, early-stage cervical cancer, according to a large cohort study published May 15 in JAMA Network Open. Consistent with prior research, the findings add to the growing body of evidence supporting conservative…

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By: Matt Danford
June 2, 2025
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Post-pandemic surge in excess US deaths exposes public health decline

Editor's Note The United States recorded more than 1.5 million excess deaths in 2022 and 2023 alone—avoidable fatalities that would not have occurred if US death rates matched those of other wealthy nations, according to a May 23 article in CIDRAP reporting on a Boston University–led study published in JAMA…

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By: Matt Danford
May 28, 2025
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Pembrolizumab sets new standard in advanced head and neck cancer surgery, trial shows

Editor's Note According to results from a randomized trial, titled KEYNOTE-689, adding pembrolizumab (Keytruda) to surgery and standard adjuvant therapy significantly prolongs event-free survival (EFS) in patients with resectable, locally advanced head and neck squamous cell carcinoma (HNSCC), MedPage Today April 28 reports. Experts are calling the findings a major…

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By: Tarsilla Moura
April 29, 2025
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Study: Mortality prediction models fail to recognize severe patient injuries

Editor's Note Machine learning (ML) models designed to predict patient mortality are falling short when it comes to identifying severe injuries that could lead to death, according to a March 27 report in TechTarget. The article focuses on research published in Nature Communications Medicine found that ML mortality prediction models…

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By: Matt Danford
April 7, 2025
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