FDA Device recall 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
- FDA Device
- Class III
- terminated
- Published 2019-08-28
On 2019-08-28 the FDA classified a Class III 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 by Cincinnati Sub Zero Products A Gentherm, citing updated Manual-Warnigs have been added stating that exceeding 40'C for extended periods may cause tissue damage.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2291-2019 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2019-07-19 |
| Published | 2019-08-28 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Cincinnati Sub Zero Products A Gentherm |
| Distribution | US |
Product
MICRO-TEMP LT System, Model 749- Localized Heat Therapy System is intended to warm a patient's body part through conductive heat transfer.
Reason
Updated Manual-Warnigs have been added stating that exceeding 40'C for extended periods may cause tissue damage
Identifiers
| code_info | Serial Numbers 141-LT-02789 through 193-LT-05137 UDI: 10613031881165 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2291-2019%22
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