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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 91177

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

Open FDA event record

Event summary

Timeline bucket
December 02, 2022
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Tomy International 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

Lamaze Chill Teether, Fluid-Filled Teething Ring, Model No. Y5288L

Z-0766-2023
Recall number
Z-0766-2023
Initiated
December 02, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Tomy International Inc.
Quantity
approx 55,000 North America

App-derived interpretation

Microbial contamination reason.microbial_contamination · v1.0.0
microbial growth

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Affected lots of the product are being recalled due to potential microbial growth in the fluid inside the device. if a compromised product is used by a child with a weakened immune system, an infection or other illness could occur.

Code information

UDI-DI B268Y5288L0 Lot Numbers E1920ALP01 and K1920ALP01

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Australia, Mauritius, Dominican Republic.