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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 69568

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

Open FDA event record

Event summary

Timeline bucket
October 10, 2014
Product types
Device
Classifications
Class I
Statuses
Terminated
Recalling firm wording
Philips Medical Systems, Inc.

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 : 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
Recall number
Z-0206-2015
Initiated
October 10, 2014
Classification
Class I
Status
Terminated
Quantity
336,695 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Mold on gel filled Gel-E and Squishon products

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

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.