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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 89193

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

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Event summary

Timeline bucket
November 22, 2021
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Gentherm Medical, LLC

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

Electri-Cool II Portable Cold Therapy Unit, Model Number 767, Part Number 86193

Z-0496-2022
Recall number
Z-0496-2022
Initiated
November 22, 2021
Classification
Class II
Status
Terminated
Recalling firm
Gentherm Medical, LLC
Quantity
484 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
This recall has been initiated to provide a labeling update with revised instruction how to operate the unit with Cold Therapy pads.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

This recall has been initiated to provide a labeling update with revised instruction how to operate the unit with Cold Therapy pads.

Code information

UDI- 10613031861938; Affected Serial Numbers are: (164-76703084 Through 213-76703694)

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Chile, Hong Kong, Korea, UAE.