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.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency 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."
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…
- 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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