Childrens Medical Ventures: Medical Device Recall in 2014 - (Recall #: Z-2192-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

Gel-E Donut, Squishon 2 gel pillows Product Usage:: The products are intended to support and cradle a baby s head and/or body. The rectangular shape of the Squishon product allows for head movement while maintaining a supportive surface and provides an effective ventral support for prone positioning. The round shape of the Gel-E Donut products help alleviate pressure caused by prolonged immobility or other conditions where frequent repositioning is contraindicated.

Product Classification:

Class I

Date Initiated: May 28, 2014

Date Posted: August 27, 2014

Recall Number: Z-2192-2014

Event ID: 68443

Reason for Recall:

The gel-filled Gel-E Donut and Squishon product line has received a number of complaints about visible mold. The mold detected was determined to be Cladosporium and Penicillium Fungi, which are commonly found molds.

Status: Terminated

Product Quantity: 332,649

Code Information:

All lots of models: 92025-A, 92025-B, 92025-C, 91033-2

Distribution Pattern:

Worldwide Distribution - USA (nationwide) including the country of Canada.

Voluntary or Mandated:

Voluntary: Firm initiated