Severity
Low
LowClass IIITerminated
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
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
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 FDA Devices action (record #Z-2291-2019) was formally reported on August 28, 2019, with the manufacturer initiating the action on July 19, 2019. It is classified under Low severity (Class III), with a current status of Terminated. Cincinnati Sub-Zero Products LLC, a Gentherm Company is listed as the recalling firm, operating out of Cincinnati, OH. Federal records list the affected scope as 2079 units.
The documented reason for this recall is: Updated Manual-Warnigs have been added stating that exceeding 40'C for extended periods may cause tissue damage Distribution data in the federal record shows the product reached: Nationwide Foreign: AUSTRALIA CANADA CHILE COLOMBIA COLOMBIA GUATEMALA ISRAEL JAPAN NETHERLANDS POLAND SINGAPORE SOUTH KOREA UNITED ARAB EMIRATES. Distribution scope 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 - 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 - 40,422 medical devices recalls on record
Where this recall sits in the database
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. 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.
Affected scope
2079 units
Related Recalls
6
0 from same agency
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.
Frequently Asked Questions
What product was recalled? ▼
MICRO-TEMP LT System, Model 749- Localized Heat Therapy System is intended to warm a patient's body part through conductive heat transfer.. Recalled by Cincinnati Sub-Zero Products LLC, a Gentherm Company. Units affected: 2079 units.
Why was this product recalled? ▼
Updated Manual-Warnigs have been added stating that exceeding 40'C for extended periods may cause tissue damage
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 28, 2019. Severity: Low. Recall number: Z-2291-2019.
Where was the recalled product distributed? ▼
Distribution: Nationwide Foreign: AUSTRALIA CANADA CHILE COLOMBIA COLOMBIA GUATEMALA ISRAEL JAPAN NETHERLANDS POLAND SINGAPORE SOUTH KOREA UNITED ARAB EMIRATES.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2291-2019) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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What to do next
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Data Sources
Source: FDA, CPSC, and NHTSA federal recall databases. This recall: FDA Devices, reported August 28, 2019.
- Source: FDA - Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
- Source: CPSC - Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
- Source: NHTSA - National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.