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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 68443

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
May 28, 2014
Product types
Device
Classifications
Class I
Statuses
Terminated
Recalling firm wording
Childrens Medical Ventures

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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.

Z-2192-2014
Recall number
Z-2192-2014
Initiated
May 28, 2014
Classification
Class I
Status
Terminated
Quantity
332,649

App-derived interpretation

Microbial contamination reason.microbial_contamination · v1.0.0
detected was determined to be Cladosporium and Penicillium

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Material/Component Contamination

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

All lots of models: 92025-A, 92025-B, 92025-C, 91033-2

Distribution pattern

Worldwide Distribution - USA (nationwide) including the country of Canada.