No Longer Accepting Cases

September 9, 2014 — The U.S. Food and Drug Administration (FDA) has issued a Class I Recall for the Gel-E Donut and Squishon 2 infant pillows after receiving complaints about visible mold on the surface of the pillows.

Tests detected the following molds:

  • Cladosporium: Known to cause several types of invasive infections, including skin, eye, sinus, and brain infections. These infections are especially common in vulnerable populations, such as infants, patients who are very sick, or patients with weak immune systems.
  • Penicillum Fungi: Can cause breathing difficulty or allergic reaction.

These soft gel-filled pillows are used in hospitals to help support and cradle an infant’s head and/or body. They also ease the pressure caused by long periods of stillness and allow the head to move while still providing a supportive surface. The pillows are commonly used to reduce bilateral head flattening in premature infants.

The recall affects Gel-E Donut with Model Numbers 92025-A, 92025-B, 92025-C, and Squishon 2 with Model number 91033-2. The products were manufactured and distributed from July 1, 2012 to December 31, 2013.

The manufacturer, Children’s Medical Ventures, warned:

“Mold should be readily seen as black dots or splotches through the transparent outer packaging. Please do not open the packaging to do the inspection. If you are unsure or if the inspection is inconclusive, please err on the side of caution and designate that product as containing mold.”