MICRO-TEMP LT System (Cincinnati Sub-Zero) – Therapy Warning (2019)
This recall may present a risk under certain conditions.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
MICRO-TEMP LT System, Model 749- Localized Heat Therapy System is intended to warm a patient's body part through conductive heat transfer.
Brand
Cincinnati Sub-Zero Products LLC, a Gentherm Company
Lot Codes / Batch Numbers
Serial Numbers 141-LT-02789 through 193-LT-05137 UDI: 10613031881165
Products Sold
Serial Numbers 141-LT-02789 through 193-LT-05137 UDI: 10613031881165
Cincinnati Sub-Zero Products LLC, a Gentherm Company is recalling MICRO-TEMP LT System, Model 749- Localized Heat Therapy System is intended to warm a patient's body due to Updated Manual-Warnigs have been added stating that exceeding 40'C for extended periods may cause tissue damage. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Updated Manual-Warnigs have been added stating that exceeding 40'C for extended periods may cause tissue damage
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026