Philips Medical Systems, Inc.: Medical Device Recall in 2014 - (Recall #: Z-0206-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class I

Date Initiated: October 10, 2014

Date Posted: December 3, 2014

Recall Number: Z-0206-2015

Event ID: 69568

Reason for Recall:

Mold on gel filled Gel-E and Squishon products

Status: Terminated

Product Quantity: 336,695 units

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.

Voluntary or Mandated:

Voluntary: Firm initiated