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.
FDA Recall Z-0206-2015 · Posted 2014-12-16
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Recalling FirmPhilips Medical Systems, Inc.
Recall StatusTerminated
Product CodeFMP
Date Initiated2014-10-10
Date Terminated2016-11-29
Product Quantity336,695 units
Reason for Recall
Mold on gel filled Gel-E and Squishon products
Firm Action
Philips Healthcare/Children's Medical Ventures issued a Medical Device Recall Letter dated Oct 10, 2014. Customers were asked to discontinue use and dispose of all product in their facility, even if mold is not visible. Following these actions, customers will be asked to return a reply form indicating that these actions have been completed. Customers will be given credit for all disposed products. Further, the Gel-E Donut and Squishon 2 products will be withdrawn from the market. Customers with questions were instructed to contact their Philips/Children's Medical Ventures representative.
For questions regarding this recall call 978-687-1501.
Root Cause
Material/Component Contamination
Distribution Pattern
Worldwide Distribution - USA (nationwide) 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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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