FDA Device recall Z-2192-2014
Gel-E Donut, Squishon 2 gel pillows Product Usage:: The products are intended to support and cradle a baby s head and/or body
- FDA Device
- Class I
- terminated
- Published 2014-08-27
On 2014-08-27 the FDA classified a Class I recall of Gel-E Donut, Squishon 2 gel pillows Product Usage:: The products are intended to support and cradle a baby s head and/or body by Childrens Medical Ventures, citing 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 Fu….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2192-2014 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2014-05-28 |
| Published | 2014-08-27 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Childrens Medical Ventures |
| Distribution | US |
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
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.
Identifiers
| code_info | All lots of models: 92025-A, 92025-B, 92025-C, 91033-2 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2192-2014%22
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