FDAClass IAugust 27, 2014

Gel-E Donut recall: Mold

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…

Why was Gel-E Donut recalled?

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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

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…
Recalling firm
Childrens Medical Ventures
Quantity
332,649
Distribution
Worldwide Distribution - USA (nationwide) including the country of Canada.
Recall date
August 27, 2014
Classification
Class I
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls