FDA Device recall Z-0206-2015
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 cra…
- FDA Device
- Class I
- terminated
- Published 2014-12-03
On 2014-12-03 the FDA classified a Class I 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 cra… by Philips Medical Systems, citing mold on gel filled Gel-E and Squishon products.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0206-2015 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2014-10-10 |
| Published | 2014-12-03 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Philips Medical Systems |
| Distribution | US |
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
Mold on gel filled Gel-E and Squishon products
Identifiers
| code_info | All lot codes |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0206-2015%22
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