Gel-E Donut — Class I medical device recall Z-2192-2014

Terminated recall by Childrens Medical Ventures, reported 2014-08-27, distributed nationwide. The gel-filled Gel-E Donut and Squishon product line has received a number of complaints about visible mold. T

Recall number	`Z-2192-2014`
Product type	Medical device
Classification	Class I
Status	Terminated
Voluntary or mandated	Voluntary
Recalling firm	Childrens Medical Ventures, Monroeville, PA, United States
Recall initiated	2014-05-28
Classified	2014-08-20
Reported by FDA	2014-08-27
Terminated	2016-11-29
Distributed	Nationwide (US)
Countries outside the US	CA
Quantity	332,649
Reason classes	microbial contamination
Pathogens	mold
Model numbers	`91033-2`, `92025-A`, `92025-B`, `92025-C`

Product

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.

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2192-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.