# FDA recall Z-2355-2019

> **Cincinnati Sub-Zero Products LLC, a Gentherm Company** · Class II · device recall initiated 2019-06-20.

## Product

Norm-O-Temp  model 111Z

## Reason for recall

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

## Distribution

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

## Key facts

- **Recall number:** Z-2355-2019
- **Recalling firm:** Cincinnati Sub-Zero Products LLC, a Gentherm Company
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-06-20
- **Report date:** 2019-09-11
- **Termination date:** 2020-06-09

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Cincinnati, OH, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2355-2019

## Citation

> AI Analytics. FDA recall Z-2355-2019. Retrieved 2026-06-10 from https://api.ai-analytics.org/recall/Z-2355-2019. Source: US FDA. Licensed CC0.

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