(Reuters) – The U.S. Food and Drug Administration (FDA) on Wednesday classified Philips’ expanded recall of certain ventilators late last year as Class 1, or the most serious type of recall, saying they could lead to injuries or death.
The Dutch medical equipment company initiated the recall of 215 Trilogy Evo ventilators and 51 repair kits in the United States in December due to potential health risks from a type of foam used in the devices.
So far, there have been no reported injuries or deaths from the products, which were distributed in the United States and Korea, the FDA said.
This is the latest recall by Philips to be labeled Class 1 after it pulled back up to 4 million breathing-aid machines last year amid concerns that a polyurethane foam used in the devices could degrade and become toxic.
Earlier this month, the company raised that estimate by 1 million.
Philips was not immediately available for comment.
A Philips supplier had incorrectly used the polyurethane foam, which is intended to reduce sound and vibration, in one of the parts of the Trilogy Evo ventilators – an issue that was identified during lab testing, according to the regulator.
The foam could break down and potentially enter the device’s air pathway, leading to the user inhaling chemicals or other harmful materials, the FDA said.
($1 = 0.8880 euros)
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