CLASS I Device recall · Reported 27 Aug 2014 · FDA Enforcement Report
Gel-E Donut, Squishon 2 gel pillows recalled
Childrens Medical Ventures is recalling Gel-E Donut, Squishon 2 gel pillows, distributed nationwide in the US. The recall was initiated on 28 May 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-2192-2014
- FDA event ID
- 68443
- Recalling firm
- Childrens Medical Ventures, Monroeville, PA
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 28 May 2014
- FDA classified
- 20 Aug 2014
- Reported
- 27 Aug 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Mold
- Device type
- Wheelchairs, Beds & Lifts
Timeline
| 28 May 2014 | Recall initiated by company | |
| 20 Aug 2014 | Classified by FDA | +84 days |
| 27 Aug 2014 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The gel-filled Gel-E Donut and Squishon product line has received a number of complaints about visible mold. The mold detected was determined to be Cladosporium and Penicillium Fungi, which are commonly found molds.
Product as listed by the FDA
Gel-E Donut, Squishon 2 gel pillows Product Usage:: The products are intended to support and cradle a baby s head and/or body. The rectangular shape of the Squishon product allows for head movement while maintaining a supportive surface and provides an effective ventral support for prone positioning. The round shape of the Gel-E Donut products help alleviate pressure caused by prolonged immobility or other conditions where frequent repositioning is contraindicated.
Where it was distributed
Worldwide Distribution - USA (nationwide) including the country of Canada.
Questions about this recall
Why was it recalled?
The gel-filled Gel-E Donut and Squishon product line has received a number of complaints about visible mold. The mold detected was determined to be Cladosporium and Penicillium Fungi, which are commonly found molds.
Which lots are affected?
All lots of models: 92025-A, 92025-B, 92025-C, 91033-2
Where was it sold?
Worldwide Distribution - USA (nationwide) including the country of Canada.
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Childrens Medical Ventures
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Philips/Children's Medical Ventures Smart Monitor recalled | Childrens Medical Ventures | Device Malfunction | 14 states |
Other Wheelchairs, Beds & Lifts recalls
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|---|---|---|---|---|---|
| Device | CLASS II | Quantum Rehab Quantum 4Front 2HD recalled by Pride Mobility Products | Pride Mobility Products | Device Malfunction | Nationwide |
| Device | CLASS II | Quantum Rehab Q6 Edge 2.0 (ilevel) recalled by Pride Mobility Products | Pride Mobility Products | Device Malfunction | Nationwide |
| Device | CLASS II | Quantum Rehab Q6 Edge recalled by Pride Mobility Products | Pride Mobility Products | Device Malfunction | Nationwide |
| Device | CLASS II | Quantum rehab Q6 Edge recalled by Pride Mobility Products | Pride Mobility Products | Device Malfunction | Nationwide |
| Device | CLASS II | Quantum Rehab Q6 Edge recalled by Pride Mobility Products | Pride Mobility Products | Device Malfunction | Nationwide |