FDA-Device2014-12-03Class I
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.
Philips Medical Systems, Inc.
Hazard
Mold on gel filled Gel-E and Squishon products
Sold states
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.
Affected count
336,695 units
Manufactured in
3000 Minuteman Rd, N/A, Andover, MA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0206-2015Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief