Severity
Critical
CriticalClass ITerminated
FDA Devices recall · Reported August 27, 2014
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.
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 F…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Childrens Medical Ventures recalled Gel-E Donut, Squishon 2 gel pillows Product Usage:: The products are intended to suppo… - a critical-severity action.
Gel-E Donut, Squishon 2 gel pillows Product Usage:: The products are intended to suppo… was recalled by Childrens Medical Ventures in August 27, 2014. Reason: The gel-filled Gel-E Donut and Squishon product line has received a number of complaints about visible mold. …. Check the official notice for the remedy. Verify recall #Z-2192-2014 with the FDA Devices before acting.
The recall
Childrens Medical Ventures issued this critical-severity FDA Devices recall-The gel-filled Gel-E Donut and Squishon product line has received a number of complaints about visible mold. ….
- Critical
- severity level
- 333K units
- affected scope
- Class I
- classification
- August 27, 2014
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2192-2014 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2192-2014) was formally reported on August 27, 2014, with the manufacturer initiating the action on May 28, 2014. It is classified under Critical severity (Class I), with a current status of Terminated. Childrens Medical Ventures is listed as the recalling firm, operating out of Monroeville, PA. Federal records list the affected scope as 332,649, a scale large enough to require multi-state distribution tracking.
The documented reason for this recall is: 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. Distribution data in the federal record shows the product reached: Worldwide Distribution - USA (nationwide) including the country of Canada.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
332,649
Related Recalls
6
3 from same agency
Product description
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.
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | Z-2192-2014 |
| Date reported | August 27, 2014 |
| Date initiated | May 28, 2014 |
| Recalling firm | Childrens Medical Ventures |
| Firm location | Monroeville, PA |
| Affected scope | 332,649 |
| Distribution | Worldwide Distribution - USA (nationwide) including the country of Canada. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2192-2014) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Childrens Medical Ventures. Units affected: 332,649.
Why was this product 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 agency issued this recall? ▼
This recall was issued by the FDA Devices on August 27, 2014. Severity: Critical. Recall number: Z-2192-2014.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - USA (nationwide) including the country of Canada..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2192-2014) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported August 27, 2014. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.