Agency classClass IIOur severity:High FDA (Devices)·Z-2356-2019·Announced 2019-09-11

Norm-O-Temp 111W Medical Device Recalled for Missing Tissue Damage Warning

Cincinnati Sub-Zero Products LLC is recalling Norm-O-Temp model 111W units because the manual lacks instructions warning that exceeding 40 Celsius for extended periods can cause tissue damage.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product (potential tissue damage) where the hazard is explicitly stated in the source text, but no specific injuries or illnesses are reported, fitting the criteria for a High severity score.

Plain-English summary

Cincinnati Sub-Zero Products LLC, a Gentherm Company, is recalling 1,063 units of the Norm-O-Temp model 111W medical device. The recall is due to a labeling deficiency where the user manual does not provide instructions stating that exceeding 40 Celsius for extended periods can cause tissue damage.

The affected units have serial numbers ranging from 091-N6669-192-N7901 and are identified by UDI codes 10613031861563, 10613031861570, 10613031861587, and 10613031861617, as well as part numbers 86156, 86157, 86158, and 86161. The devices were distributed to various states in the United States and numerous international countries.

Consumers and healthcare facilities should check their inventory for these specific serial and part numbers. If the device is found, users should follow the instructions provided by the recalling firm or the FDA regarding the return or replacement of the unit to ensure patient safety.

The recalled product

Product: Norm-O-Temp model 111W
Manufacturer: Cincinnati Sub-Zero Products LLC, a Gentherm Company
Category: Medical Device — Thermal Therapy
Hazard: burn-injury
mis-labeling
Affected units: 1,063

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (7)

Serial number Range: 091-N6669-192-N7901 UDI: 10613031861563
10613031861570
10613031861587
10613031861617 Part # 86156
86157
86158
86161

Distribution

Distributed in 42 states:

Part of a larger recall action

This product is one of 2 recalled by Cincinnati Sub-Zero Products LLC, a Gentherm Company under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · Cincinnati Sub-Zero Products LLC, a Gentherm Company

See all →

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High
Cincinnati Sub-Zero Recalls CoolBlue Hyper-Hypothermia Systems for Tissue Damage Risk
FDA (Devices) · 2019-11-27
High
Norm-O-Temp 111Z Medical Device Recalled for Missing Tissue Damage Warning
FDA (Devices) · 2019-09-11
Low
FDA Recalls MICRO-TEMP LT Heat Therapy Systems Due to Tissue Damage Risk
FDA (Devices) · 2019-08-28

Same hazard · burn injury