Norm-O-Temp recallZ-2355-2019 · Cincinnati Sub-Zero Products LLC, a Gentherm Company · initiated Jun 20, 2019
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Cincinnati Sub-Zero Products LLC, a Gentherm Company or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The manual does not provide instruction stating that exceeding 40 Celsius for extended periods can cause tissue damage.
FDA root cause category: Labeling False and Misleading
What the company is doing
1. Access updated manuals and ensure that obsolete manuals are removed from services. updated manuals may be accessed via www.gentherm.com or physical copies may be requested from Gentherm Medical, LLC at 1-888-437-5608 2. Inform the content of the notification to all users and if you have further distributed this product, please provide those account with a copy of this notice. 3. Please complete and return the enclosed response form as soon as receipt of this notification and to inform Gentherm Medical, LLC and return the form by e-mail to [email protected] or mail to : Gentherm Medical, LLC, 12011 Mosteller Road, Cincinnati, OH 45241. If you have any questions, call Gentherm Medical Technical Support at 1-888-437-5608.
Recall details
- Recall number
- Z-2355-2019
- Status
- Terminated
- Initiated by the company
- Jun 20, 2019
- Recalling firm
- Cincinnati Sub-Zero Products LLC, a Gentherm Company
- Quantity
- 674
- Product code
- DWJ
- FDA submissions
- K120081
- 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
Product description
Norm-O-Temp model 111Z
Code information (models, lots, serial numbers)
Serial Number Range : 113-0001N-192-0798N UDI : 10613031861549 and 10613031861532 Part # 86153, 86154
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Norm-O-Temp® 111ZGentherm Medical, LLC · System, Thermal Regulating1 recall2 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page