Philips Medical Systems Recalls Gel-E and Squishon Baby Support Products Due to Mold
Philips Medical Systems is recalling Gel-E Donut and Squishon 2 baby support products because mold was found on the gel-filled items.
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: "Mold on gel filled Gel-E and Squishon products"
Plain-English summary
Philips Medical Systems, Inc. is recalling specific models of Gel-E Donut (92025-A, 92025-B, 92025-C) and Squishon 2 (91033-2) products. These items are intended to support and cradle a baby's head and/or body. The recall is being conducted because mold was found on the gel-filled products.
Approximately 336,695 units were distributed nationwide in the United States and internationally to Canada, Australia, Austria, Belgium, France, Germany, Iceland, Ireland, Italy, Japan, Kuwait, Netherlands, New Zealand, Norway, Portugal, Reunion, Romania, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Thailand, and the United Kingdom. All lot codes are affected.
Consumers should stop using these products immediately. The source text does not specify a particular consumer action such as returning the product or contacting the manufacturer for a refund, but the presence of mold on a product intended for infant use necessitates discontinuation of use.
The recalled product
- Product
- Gel-E Donut : 92025-A (Extra Small), 92025-B (Small), 92025-C (Medium) and Squishon 2 91033-2. The products are intended to support and cradle a baby's head and/or body.
- Manufacturer
- Philips Medical Systems, Inc.
- Hazard
- Affected units
- 336,695
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 (1)
- All lot codes
Distribution
Distributed nationwide across the United States.
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