Z-2291-2019Class III

MICRO-TEMP LT System, Model 749- Localized Heat Therapy System is intended to warm a patient's body part...

Name: Z-2291-2019 MICRO-TEMP LT System, Model 749- Localized Heat Therapy System is intended to warm a patient's body part...
Creator: Cincinnati Sub-Zero Products LLC, a Gentherm Company
Published: 2019-07-19
License: https://open.fda.gov/license/

Gentherm Medical, LLC / initiated 2019-07-19 / Terminated

FDA source

Cincinnati Sub-Zero Products LLC, a Gentherm Company began a recall of MICRO-TEMP LT System, Model 749- Localized Heat Therapy System is intended to warm a patient's body part through conductive heat transfer on 2019-07-19. FDA classified it as Class III and gives the reason as "Updated Manual-Warnigs have been added stating that exceeding 40'C for extended periods may cause tissue damage". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2291-2019
Classification: Class III
Status: Terminated
Initiated: 2019-07-19
Posted: 2019-08-19
Terminated: 2020-05-13
Recalling firm: Gentherm Medical, LLC
Product: MICRO-TEMP LT System, Model 749- Localized Heat Therapy System is intended to warm a patient's body part through conductive heat transfer.
Product code: ILO Pack, Hot Or Cold, Water Circulating
Reason for recall: Updated Manual-Warnigs have been added stating that exceeding 40'C for extended periods may cause tissue damage
FDA root cause: Under Investigation by firm
Action: 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.
Quantity in commerce: 2079 units
Distribution: Nationwide Foreign: AUSTRALIA CANADA CHILE COLOMBIA COLOMBIA GUATEMALA ISRAEL JAPAN NETHERLANDS POLAND SINGAPORE SOUTH KOREA UNITED ARAB EMIRATES
Product codes and lots: Serial Numbers 141-LT-02789 through 193-LT-05137 UDI: 10613031881165

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2291-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2291-2019	Class III	Terminated	Voluntary: Firm initiated	2019-08-28	2019-08-19

Product code ILO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)