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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 92275

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

Open FDA event record

Event summary

Timeline bucket
May 10, 2023
Product types
Device
Classifications
Class I
Statuses
Terminated
Recalling firm wording
BearCare, 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

Walnut Wearable Smart Thermometer, intended for continuous chest temperature monitoring of children ages 0-6 years in non-emergency medical situations, Model Number WT20

Z-1633-2023
Recall number
Z-1633-2023
Initiated
May 10, 2023
Classification
Class I
Status
Terminated
Recalling firm
BearCare, Inc.
Quantity
1818 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There have been reports of skin burns to children wearing the device.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There have been reports of skin burns to children wearing the device.

Code information

Lot Number 20221115W002

Distribution pattern

US Nationwide distribution.