Norm-O-Temp 111Z Medical Device Recalled for Missing Tissue Damage Warning
Cincinnati Sub-Zero Products LLC is recalling Norm-O-Temp model 111Z devices 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 (tissue damage from heat) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Cincinnati Sub-Zero Products LLC, a Gentherm Company, is recalling 674 units of the Norm-O-Temp model 111Z medical device. The recall was initiated because the product manual does not provide instructions stating that exceeding 40 Celsius for extended periods can cause tissue damage.
The affected devices are identified by serial number range 113-0001N-192-0798N, UDI 10613031861549 and 10613031861532, and part numbers 86153 and 86154. The devices were distributed to various U.S. states and international locations, including the United States, Canada, and several countries in Europe, Asia, and the Middle East.
Consumers and healthcare providers should check their devices for the affected serial numbers and part numbers. If a device is affected, users should stop using it and contact the recalling firm for further instructions.
The recalled product
- Product
- Norm-O-Temp model 111Z
- Category
- Medical Device — Thermal Therapy
- Hazard
- Affected units
- 674
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 (1)
- 86154
Distribution
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.
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