CLASS II Device recall · Reported 11 Sep 2019 · FDA Enforcement Report

Norm-O-Temp model 111Z recalled by Cincinnati Sub-Zero Products

Cincinnati Sub-Zero Products LLC, a Gentherm is recalling Norm-O-Temp model 111Z, distributed in 36 states. The recall was initiated on 20 Jun 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial Number Range : 113-0001N-192-0798N UDI : 10613031861549 and 10613031861532 Part # 86153, 86154

Quantity recalled674

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2355-2019
FDA event ID: 83376
Recalling firm: Cincinnati Sub-Zero Products LLC, a Gentherm, Cincinnati, OH
Classification: Class II
Status: Terminated
Recall initiated: 20 Jun 2019
FDA classified: 4 Sep 2019
Reported: 11 Sep 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

20 Jun 2019	Recall initiated by company
4 Sep 2019	Classified by FDA	+76 days
11 Sep 2019	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

Norm-O-Temp model 111Z

Where it was distributed

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

Alabama Arkansas Arizona California Colorado Connecticut District of Columbia Florida Georgia Illinois Kansas Kentucky Louisiana Massachusetts Maryland Michigan Minnesota Missouri North Carolina North Dakota

Questions about this recall

Is Norm-O-Temp model 111Z recalled?

Yes. Cincinnati Sub-Zero Products LLC, a Gentherm recalled Norm-O-Temp model 111Z on 20 Jun 2019. The recall is Class II and its status is Terminated. Recall number Z-2355-2019.

Why was it recalled?

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

Which lots are affected?

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

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Cincinnati Sub-Zero Products LLC, a Gentherm

All 8

Reported	Class	Recall	Company	Reason	Where
27 Nov 2019Device	CLASS II	Blanketrol II Hyper-Hypothermia System recalled	Cincinnati Sub-Zero Products LLC, a Gentherm	Other	Nationwide
27 Nov 2019Device	CLASS II	Blanketrol III Hyper-Hypothermia System- body hypothermia recalled	Cincinnati Sub-Zero Products LLC, a Gentherm	Temperature Abuse	Nationwide
27 Nov 2019Device	CLASS II	CoolBlue Hyper-Hypothermia System- body hypothermia system recalled	Cincinnati Sub-Zero Products LLC, a Gentherm	Other	Nationwide
11 Sep 2019Device	CLASS II	Norm-O-Temp model 111W recalled by Cincinnati Sub-Zero Products	Cincinnati Sub-Zero Products LLC, a Gentherm	Device Malfunction	36 states
28 Aug 2019Device	CLASS III	Micro-temp LT System recalled by Cincinnati Sub-Zero Products	Cincinnati Sub-Zero Products LLC, a Gentherm	Other	Nationwide

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