CLASS I Device recall · Reported 3 Dec 2014 · FDA Enforcement Report
Gel-E Donut : 92025-A (Extra Small), 92025-B (Small) recalled
Philips Medical Systems is recalling Gel-E Donut : 92025-A (Extra Small), 92025-B (Small), 92025-C (Medium) and Squishon 2, distributed nationwide in the US. The recall was initiated on 10 Oct 2014 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0206-2015
- FDA event ID
- 69568
- Recalling firm
- Philips Medical Systems, Andover, MA
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 10 Oct 2014
- FDA classified
- 21 Nov 2014
- Reported
- 3 Dec 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Mold
- Device type
- Other Medical Devices
Timeline
| 10 Oct 2014 | Recall initiated by company | |
| 21 Nov 2014 | Classified by FDA | +42 days |
| 3 Dec 2014 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Mold on gel filled Gel-E and Squishon products
Product as listed by the FDA
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.
Where it was distributed
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.
Questions about this recall
Is Gel-E Donut : 92025-A (Extra Small), 92025-B (Small), 92025-C (Medium) and Squishon 2 recalled?
Yes. Philips Medical Systems recalled Gel-E Donut : 92025-A (Extra Small), 92025-B (Small), 92025-C (Medium) and Squishon 2 on 10 Oct 2014. The recall is Class I and its status is Terminated. Recall number Z-0206-2015.
Why was it recalled?
Mold on gel filled Gel-E and Squishon products
Which lots are affected?
All lot codes
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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