Food, drugs, devices › Cincinnati Sub-Zero Products LLC, a Gentherm Company
Device recall: MICRO-TEMP LT System, Model 749- Localized Heat Therapy System is intended to warm a patient's body part through conduct
Cincinnati Sub-Zero Products LLC, a Gentherm Company (Cincinnati, OH) initiated this device recall on 19 Jul 2019; FDA lists 1 product record under event 83387, classified Class III.
FDA defines Class III as a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences. 6% of the 968 device enforcement events initiated in 2019 carry the same class.
Status: Terminated, terminated 13 May 2020. Initiation: voluntary: firm initiated. Cincinnati Sub-Zero Products LLC, a Gentherm Company has 5 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Cincinnati Sub-Zero Products LLC, a Gentherm Company, Cincinnati, OH.
Reason for recall
"Updated Manual-Warnigs have been added stating that exceeding 40'C for extended periods may cause tissue damage"
Distribution
"Nationwide Foreign: AUSTRALIA CANADA CHILE COLOMBIA COLOMBIA GUATEMALA ISRAEL JAPAN NETHERLANDS POLAND SINGAPORE SOUTH KOREA UNITED ARAB EMIRATES"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2291-2019 | MICRO-TEMP LT System, Model 749- Localized Heat Therapy System is intended to warm a patient's body part through conductive heat transfer. | 2079 units | Class III | Terminated | 28 Aug 2019 |
Context
Other enforcement events for Cincinnati Sub-Zero Products LLC, a Gentherm Company
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 2 Jul 2019 | Blanketrol III Hyper-Hypothermia System- body hypothermia system temperature management Model 233 - Product Usage: The s | Device | Class II | 3 |
| 20 Jun 2019 | Norm-O-Temp model 111Z | Device | Class II | 2 |
| 19 Dec 2018 | Hemotherm CE Dual Reservoir Cooler/Heater, Model No. 400CE Product Usage: The HEMOTHERM¿ Model 400CE Dual Reservoir Cool | Device | Class II | 1 |
| 4 Sep 2018 | Hemotherm 400CE, Catalog Numbers 86022 & 86023 The Hemotherm¿ Dual Reservoir Cooler/Heater is used to lower, maintain, o | Device | Class II | 1 |
All 5 events for Cincinnati Sub-Zero Products LLC, a Gentherm Company
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Updated Manual-Warnigs have been added stating that exceeding 40'C for extended periods may cause tissue damage"
What does Class III mean?
FDA classifies recalls by relative degree of health hazard. Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
Where was the product distributed?
FDA's distribution pattern field reads: "Nationwide Foreign: AUSTRALIA CANADA CHILE COLOMBIA COLOMBIA GUATEMALA ISRAEL JAPAN NETHERLANDS POLAND SINGAPORE SOUTH KOREA UNITED ARAB EMIRATES"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 13 May 2020. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.