Z-2192-2014Class I

Gel-E Donut, Squishon 2 gel pillows

Name: Z-2192-2014 Gel-E Donut, Squishon 2 gel pillows
Creator: Childrens Medical Ventures
Published: 2014-05-28
License: https://open.fda.gov/license/

Childrens Medical Ventures, LLC / initiated 2014-05-28 / Terminated / root cause: manufacturing process

FDA source

Childrens Medical Ventures began a 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. The rectangular shape of the... on 2014-05-28. FDA classified it as Class I and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2192-2014
Classification: Class I
Status: Terminated
Initiated: 2014-05-28
Posted: 2014-08-20
Terminated: 2016-11-29
Recalling firm: Childrens Medical Ventures, LLC
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.
Product code: FMP Protector, Skin Pressure
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.
Root cause tag: manufacturing process
FDA root cause: Material/Component Contamination
Action: Childrens Medical Ventures sent an Urgent Medical Device Recall letter dated May 28, 2014, to affected customers via UPS. The letter identified the affected product, problem, and actions to be taken. Customers were instructed to review entire inventory and inspect for signs of visible mold, do not open the packaging to do the inspection, the mold should be seen through the transparent outer packing, complete and return the reply form provided on the last page of the letter, dispose of any product containing mold per your facilitys environmental guidelines, do not return any product to your Distributor or to Philips/Childrens Medical Ventures.and credit for disposed product will be given. If you need any further information or support concerning this problem, please contact your Distributor at the following phone number:
Quantity in commerce: 332,649
Distribution: Worldwide Distribution - USA (nationwide) including the country of Canada.
Product codes and lots: All lots of models: 92025-A, 92025-B, 92025-C, 91033-2

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2192-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2192-2014	Class I	Terminated	Voluntary: Firm initiated	2014-08-27	2014-08-20

Product code FMP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)