Z-0206-2015Class I

Gel-E Donut : 92025-A (Extra Small), 92025-B (Small), 92025-C (Medium) and Squishon 2 91033-2. The products...

Name: Z-0206-2015 Gel-E Donut : 92025-A (Extra Small), 92025-B (Small), 92025-C (Medium) and Squishon 2 91033-2. The products...
Creator: Philips Medical Systems, Inc.
Published: 2014-10-10
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2014-10-10 / Terminated / root cause: manufacturing process

FDA source

Philips Medical Systems, Inc. began a recall of 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... on 2014-10-10. FDA classified it as Class I and gives the reason as "Mold on gel filled Gel-E and Squishon products". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0206-2015
Classification: Class I
Status: Terminated
Initiated: 2014-10-10
Posted: 2014-12-16
Terminated: 2016-11-29
Recalling firm: Philips North America LLC
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.
Product code: FMP Protector, Skin Pressure
Reason for recall: Mold on gel filled Gel-E and Squishon products
Root cause tag: manufacturing process
FDA 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 Further, the Gel-E Donut and Squishon 2 products will be withdrawn from the market.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 in commerce: 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.
Product codes and lots: All lot codes

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0206-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0206-2015	Class I	Terminated	Voluntary: Firm initiated	2014-12-03	2014-11-21

Product code FMP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)