FDA Medical Device Recalls (openFDA)
Philips Medical Systems, Inc.: 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.
- Recall number
- Z-0206-2015
- Recalling firm
- Philips Medical Systems, Inc.
- 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.
- Status
- Terminated
- Initiated
- 2014-10-10
- Posted
- 2014-12-16
- Terminated
- 2016-11-29
- Reason
- Mold on gel filled Gel-E and Squishon products
- Root cause
- Material/Component Contamination
- 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 Further, the Gel-E Donut and Squishon 2 products will be withdrawn from the market.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.
- Quantity
- 336,695 units
- Distribution
- 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.
- Lot, serial or model codes
- All lot codes
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FMP
- Firm FEI
- 1218950
- Firm city
- Andover
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28