Gel-E Donut : 92025-A — Class I medical device recall Z-0206-2015
Terminated recall by Philips Medical Systems, Inc., reported 2014-12-03, distributed nationwide. Mold on gel filled Gel-E and Squishon products
| Recall number | Z-0206-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips Medical Systems, Inc., Andover, MA, United States |
| Recall initiated | 2014-10-10 |
| Classified | 2014-11-21 |
| Reported by FDA | 2014-12-03 |
| Terminated | 2016-11-29 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BE, CA, CH, DE, ES, FR, GB, IE, IS, IT, JP, KW, NL, NO, NZ, PT, RO, SA, SE, TH, ZA |
| Quantity | 336,695 units |
| Reason classes | microbial contamination |
| Pathogens | mold |
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.
Reason for recall
Mold on gel filled Gel-E and Squishon products
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0206-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.