Royal Philips (NYSE:PHG) widened a Class I recall of its Gel-E Donut and Squishon 2 infant hospital pillows over concerns they could be contaminated with mold.
Philips 1st issued the recall in May after receiving complaints that some of the pillows, which are often used in neonatal and pediatric intensive care units, were contaminated with Cladosporium or Penicillium fungi. Users were advised to inspect the pillows for signs of mold and dispose of any product that appeared to be contaminated.
Because both Cladosporium and Penicillium can trigger serious reactions in certain patients, the FDA classified the recall as Class I, meaning that continued use of the product could cause injury or even death.
According to the FDA, Philips issued a 2nd recall Oct. 10 after receiving a dozen new complaints about moldy pillows, including 1 report of injury. The company is now advising users to dispose of all Gel-E Donut and Squishon 2 pillows, regardless of whether they show signs of mold.
The recall covers Gel-E Donut and Squishon 2 pillows manufactured and distributed from July 2012 to August 2014.
Earlier this month, Philips’ Respironics unit issued a Class I recall for its Esprit V1000 and V200 ventilators over concerns the machines could fail to operate on AC power.