Z-2355-2019Class II

Norm-O-Temp model 111Z

Name: Z-2355-2019 Norm-O-Temp model 111Z
Creator: Cincinnati Sub-Zero Products LLC, a Gentherm Company
Published: 2019-06-20
License: https://open.fda.gov/license/

Gentherm Medical, LLC / initiated 2019-06-20 / Terminated / root cause: labeling and UDI

FDA source

Cincinnati Sub-Zero Products LLC, a Gentherm Company began a recall of Norm-O-Temp model 111Z on 2019-06-20. FDA classified it as Class II and gives the reason as "The manual does not provide instruction stating that exceeding 40 Celsius for extended periods can cause tissue damage". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2355-2019
Classification: Class II
Status: Terminated
Initiated: 2019-06-20
Posted: 2019-09-04
Terminated: 2020-06-09
Recalling firm: Gentherm Medical, LLC
Product: Norm-O-Temp model 111Z
Product code: DWJ System, Thermal Regulating
Reason for recall: The manual does not provide instruction stating that exceeding 40 Celsius for extended periods can cause tissue damage.
Root cause tag: labeling and UDI
FDA root cause: Labeling False and Misleading
Action: 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.
Quantity in commerce: 674
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 codes and lots: Serial Number Range : 113-0001N-192-0798N UDI : 10613031861549 and 10613031861532 Part # 86153, 86154

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2355-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2355-2019	Class II	Terminated	Voluntary: Firm initiated	2019-09-11	2019-09-04
Z-2356-2019	Class II	Terminated	Voluntary: Firm initiated	2019-09-11	2019-09-04

Product code DWJ

K120081Class IINorm-O-Temp Hyperthermia System Incliding Blankets/padsCincinnati Sub-Zero Products, Inc. / cleared 2012-02-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)