Cincinnati Sub-Zero Products LLC, a Gentherm Company Norm-O-Temp model 111W Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Norm-O-Temp model 111W
Brand
Cincinnati Sub-Zero Products LLC, a Gentherm Company
Lot Codes / Batch Numbers
Serial number Range: 091-N6669-192-N7901 UDI: 10613031861563, 10613031861570, 10613031861587, 10613031861617 Part # 86156, 86157, 86158, 86161
Products Sold
Serial number Range: 091-N6669-192-N7901 UDI: 10613031861563, 10613031861570, 10613031861587, 10613031861617 Part # 86156, 86157,86158, 86161
Cincinnati Sub-Zero Products LLC, a Gentherm Company is recalling Norm-O-Temp model 111W due to The manual does not provide instruction stating that exceeding 40 Celsius for extended periods can cause tissue damage.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The manual does not provide instruction stating that exceeding 40 Celsius for extended periods can cause tissue damage.
Recommended Action
Per FDA guidance
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 FA2019-005@gentherm.com 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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026