FDA Recalls Gel-E Donut and Squishon Baby Pillows Due to Mold
Childrens Medical Ventures is recalling Gel-E Donut and Squishon 2 gel pillows because of visible mold. The mold was identified as Cladosporium and Penicillium fungi.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall involves a medical device with a contamination issue (mold) that is described as 'commonly found' and does not report specific illnesses or injuries, fitting the criteria for a moderate risk or precautionary recall.
Plain-English summary
Childrens Medical Ventures is recalling the Gel-E Donut and Squishon 2 gel pillows. These products are intended to support and cradle a baby's head and/or body. The recall covers 332,649 units distributed nationwide in the USA and in Canada.
The recall was initiated after the company received complaints regarding visible mold on the products. The mold was determined to be Cladosporium and Penicillium fungi, which are commonly found molds. The affected models are 92025-A, 92025-B, 92025-C, and 91033-2.
Consumers should stop using these products immediately. The source text does not specify a particular remedy or return process, but users should contact the manufacturer for instructions on how to proceed.
The recalled product
- 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 suppor
- Manufacturer
- Childrens Medical Ventures
- Hazard
- Affected units
- 332,649
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- All lots of models: 92025-A
- 92025-B
- 92025-C
- 91033-2
Distribution
Distributed nationwide across the United States.
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