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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 83376

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
June 20, 2019
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Cincinnati Sub-Zero Products LLC, a Gentherm Company

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

2 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 2

Norm-O-Temp model 111Z

Z-2355-2019
Recall number
Z-2355-2019
Initiated
June 20, 2019
Classification
Class II
Status
Terminated
Quantity
674

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The manual does not provide instruction stating that exceeding 40 Celsius for extended periods can cause tissue damage.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling False and Misleading

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The manual does not provide instruction stating that exceeding 40 Celsius for extended periods can cause tissue damage.

Code information

Serial Number Range : 113-0001N-192-0798N UDI : 10613031861549 and 10613031861532 Part # 86153, 86154

Distribution pattern

Ship-To State AL AR AZ CA CO CT DC DE FL GA HI IL IN KS KY LA MA MD ME MI MN MO NC ND NE NH NJ NM NY OH OK PA RI SC TN TW TX UT VA WA WI WV WY Ship-To Country United States Taiwan Egypt United Arab Emirates Israel Pakistan Turkey Colombia Thailand Kuwait United Kingdom Mexico Netherlands Canada Ecuador South Korea Germany Georgia China Panama Japan Malaysia Hong Kong Austria Chile Mongolia Morocco Australia Indonesia Venezuela Singapore

device · product 2 of 2

Norm-O-Temp model 111W

Z-2356-2019
Recall number
Z-2356-2019
Initiated
June 20, 2019
Classification
Class II
Status
Terminated
Quantity
1063

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The manual does not provide instruction stating that exceeding 40 Celsius for extended periods can cause tissue damage.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling False and Misleading

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The manual does not provide instruction stating that exceeding 40 Celsius for extended periods can cause tissue damage.

Code information

Serial number Range: 091-N6669-192-N7901 UDI: 10613031861563, 10613031861570, 10613031861587, 10613031861617 Part # 86156, 86157,86158, 86161

Distribution pattern

Ship-To State AL AR AZ CA CO CT DC DE FL GA HI IL IN KS KY LA MA MD ME MI MN MO NC ND NE NH NJ NM NY OH OK PA RI SC TN TW TX UT VA WA WI WV WY Ship-To Country United States Taiwan Egypt United Arab Emirates Israel Pakistan Turkey Colombia Thailand Kuwait United Kingdom Mexico Netherlands Canada Ecuador South Korea Germany Georgia China Panama Japan Malaysia Hong Kong Austria Chile Mongolia Morocco Australia Indonesia Venezuela Singapore