Reported Aug 27, 2014 · Terminated

Gel-E Donut, Squishon 2 gel pillows Product Usage:: The products are intended to support and cradle a baby s head…

Childrens Medical Ventures

High riskUsing this product could cause serious injury, illness or death — stop using it now.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Childrens Medical Ventures · 191 Wyngate Dr · Monroeville, PA · 15146-3045

Is this the product you have?

  • 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
Lot codes and dates
  • All lots of models
    • 92025-A
    • 92025-B
    • 92025-C
    • 91033-2
Amount recalled
332,649

Where it was sold

  • Nationwide

Why it was recalled

Stop using this product now

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.

Using this product could cause serious injury, illness or death — stop using it now.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Nov 29, 2016 · Data as of Sep 19, 6:01 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.