MICRO-TEMP LT System, Model 749- Localized Heat Therapy… recallZ-2291-2019 · Cincinnati Sub-Zero Products LLC, a Gentherm Company · initiated Jul 19, 2019
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Cincinnati Sub-Zero Products LLC, a Gentherm Company or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Updated Manual-Warnigs have been added stating that exceeding 40'C for extended periods may cause tissue damage
FDA root cause category: Under Investigation by firm
What the company is doing
Gentherm issued an Urgent Medical Device Notification on 7/19/19 via UPS informing users of the problem, health risk and action to take :Immediately examine your inventory and update manual(s) subject to recall and ensure that obsolete manuals are removed from service In addition, if you may have further distributed this product, please identify your customers and notify them at once of this product recall. INSTRUCTIONS TO CUSTOMERS: 1) Access updated manuals and ensure that obsolete manuals are removed from service. Updated manuals maybe accessed via www.gentherm.com or physical copies may be requested from Gentherm Medical, LLC at 1-888-437-0608.
Recall details
- Recall number
- Z-2291-2019
- Status
- Terminated
- Initiated by the company
- Jul 19, 2019
- Recalling firm
- Cincinnati Sub-Zero Products LLC, a Gentherm Company
- Quantity
- 2079 units
- Product code
- ILO
- Distribution
- Nationwide Foreign: AUSTRALIA CANADA CHILE COLOMBIA COLOMBIA GUATEMALA ISRAEL JAPAN NETHERLANDS POLAND SINGAPORE SOUTH KOREA UNITED ARAB EMIRATES
Product description
MICRO-TEMP LT System, Model 749- Localized Heat Therapy System is intended to warm a patient's body part through conductive heat transfer.
Code information (models, lots, serial numbers)
Serial Numbers 141-LT-02789 through 193-LT-05137 UDI: 10613031881165
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Micro-Temp LT 749Gentherm Medical, LLC · Pack, Hot Or Cold, Water Circulating1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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