FDA Device recall Z-2355-2019
Norm-O-Temp model 111Z
- FDA Device
- Class II
- terminated
- Published 2019-09-11
On 2019-09-11 the FDA classified a Class II recall of Norm-O-Temp model 111Z by Cincinnati Sub Zero Products A Gentherm, citing the manual does not provide instruction stating that exceeding 40 Celsius for extended periods can cause tissue damage.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2355-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-06-20 |
| Published | 2019-09-11 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Cincinnati Sub Zero Products A Gentherm |
| Distribution | 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, TX, UT, VA, WA, WI, WV, WY |
Product
Norm-O-Temp model 111Z
Reason
The manual does not provide instruction stating that exceeding 40 Celsius for extended periods can cause tissue damage.
Identifiers
| code_info | Serial Number Range : 113-0001N-192-0798N UDI : 10613031861549 and 10613031861532 Part # 86153, 86154 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2355-2019%22
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