Cincinnati Sub-Zero Products LLC, a Gentherm Company: Medical Device Recall in 2019 - (Recall #: Z-2355-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

Norm-O-Temp model 111Z

Product Classification:

Class II

Date Initiated: June 20, 2019

Date Posted: September 11, 2019

Recall Number: Z-2355-2019

Event ID: 83376

Reason for Recall:

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

Status: Terminated

Product Quantity: 674

Code Information:

Serial Number Range : 113-0001N-192-0798N UDI : 10613031861549 and 10613031861532 Part # 86153, 86154

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated