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Recall Observatory FDA recall evidence

Device product

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.

Z-0206-2015

October 10, 2014

Class I

Product summary

Firm
Philips Medical Systems, Inc.
Event
Event 69568
Status
Terminated
Classification
Class I
Quantity
336,695 units
Official record key
device-enforcement:Z-0206-2015

Official wording

Reason: Mold on gel filled Gel-E and Squishon products

Code information: All lot codes

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Mold on gel filled Gel-E and Squishon products