FDA Devices recall · Reported August 28, 2019
MICRO-TEMP LT System, Model 749- Localized Heat Therapy System is intended to warm a patient's body part through conductive heat transfer.
Updated Manual-Warnigs have been added stating that exceeding 40'C for extended periods may cause tissue damage
Cincinnati Sub-Zero Products LLC, a Gentherm Company recalled MICRO-TEMP LT System, Model 749- Localized Heat Therapy System is intended to warm a pati… - a low-severity action.
MICRO-TEMP LT System, Model 749- Localized Heat Therapy System is intended to warm a pati… was recalled by Cincinnati Sub-Zero Products LLC, a Gentherm Company in August 28, 2019. Reason: Updated Manual-Warnigs have been added stating that exceeding 40'C for extended periods may cause tissue dama…. Check the official notice for the remedy. Verify recall #Z-2291-2019 with the FDA Devices before acting.
The recall
Cincinnati Sub-Zero Products LLC, a Gentherm Company issued this low-severity FDA Devices recall-Updated Manual-Warnigs have been added stating that exceeding 40'C for extended periods may cause tissue dama….
- Low
- severity level
- 2K units
- affected scope
- Class III
- classification
- August 28, 2019
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2291-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 41,021 medical devices recalls on record
Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified low severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
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.
Reason for recall
Updated Manual-Warnigs have been added stating that exceeding 40'C for extended periods may cause tissue damage
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Terminated |
| Recall number | Z-2291-2019 |
| Date reported | August 28, 2019 |
| Date initiated | July 19, 2019 |
| Recalling firm | Cincinnati Sub-Zero Products LLC, a Gentherm Company |
| Firm location | Cincinnati, OH |
| Affected scope | 2079 units |
| Distribution | Nationwide Foreign: AUSTRALIA CANADA CHILE COLOMBIA COLOMBIA GUATEMALA ISRAEL JAPAN NETHERLANDS POLAND SINGAPORE SOUTH KOREA UNITED ARAB EMIRATES |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2291-2019) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Nationwide recalls with similar severity or category timing
Drug and device notices outside this firm and state, matched by severity timing and product category.
Similar severity · nearest report date
Same archive severity grade (Low), closest by report date among other firms and states.
Similar Medical Devices · nearest report date
Same product category, closest by report date among other firms and states (deduped against the severity set).
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Methodology · Corrections · Archive as of August 2026