More Headaches For Philips As FDA Labels Another Ventilator Recall As High-Risk Class I

The recalled vents are designed to provide high-flow therapy to patients, but problems can crop up “if the system pressure reaches the default maximum limit,” the US agency says. The recall is more bad news for Philips, which recently initiated a separate class I recall of certain breathing and ventilator devices.

Philips sign.

An 18 June recall by Philips Respironics of V60 and V60 Plus ventilators has been designated as high-risk class I by the US Food and Drug Administration.

More from Recalls

One Death Linked To Calyxo Urological System

 

The US FDA has issued an early alert about the CVAC system from Calyxo, which urologists use in removing urinary stones.

Class I Recall On Medtronic Embolization Device After 4 Deaths

 
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The company is recalling Pipeline Vantage 021 and 027 models because they pose a higher than normal risk of failing to properly attach to blood vessel walls, which can cause thrombosis, stroke or death. The recall for 027 is a product removal and for 021 is an update to the instructions for use.

Recall Alerts For Boston Scientific, Philips, J&J, And More

 
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The US FDA has announced seven device safety actions in recent days. The most serious, which relates to a manufacturing defect in Boston Scientific’s Accolade pacemaker, has been linked to 832 injuries and two deaths.

Class I Recalls Hit 15-Year High, According To Index Report From Sedgwick

 

Medical device recalls exceeded 1,000 in 2024, according to a recently published recall index report from Sedgwick. More than 10% of those recalls were class I, the FDA’s most serious category.

More from Policy & Regulation

Global Medtech Guidance Tracker: March 2025

 
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Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 40 documents have been posted on the tracker since its last update.

Whitaker Wants Congress To Capitalize On ‘Golden Age Of Medical Innovation’

AdvaMed’s top priorities for the 119th Congress include modernizing US Medicare services and expanding patients’ access to the latest medical technologies.

First At-Home Test For Multiple STIs Gets FDA Clearance

 
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The Visby Medical Women’s Sexual Health Test is the first over-the-counter test cleared by the US Food and Drug Administration to detect chlamydia, gonorrhea and trichomoniasis. It delivers results in about 30 minutes.