CLASS III Device recall · Reported 28 Aug 2019 · FDA Enforcement Report
Micro-temp LT System recalled by Cincinnati Sub-Zero Products
Cincinnati Sub-Zero Products LLC, a Gentherm is recalling Micro-temp LT System, distributed nationwide in the US. The recall was initiated on 19 Jul 2019 and the FDA has classified it as Class III.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2291-2019
- FDA event ID
- 83387
- Recalling firm
- Cincinnati Sub-Zero Products LLC, a Gentherm, Cincinnati, OH
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 19 Jul 2019
- FDA classified
- 19 Aug 2019
- Reported
- 28 Aug 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 19 Jul 2019 | Recall initiated by company | |
| 19 Aug 2019 | Classified by FDA | +31 days |
| 28 Aug 2019 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Updated Manual-Warnigs have been added stating that exceeding 40'C for extended periods may cause tissue damage
Product as listed by the FDA
MICRO-TEMP LT System, Model 749- Localized Heat Therapy System is intended to warm a patient's body part through conductive heat transfer.
Where it was distributed
Nationwide Foreign: AUSTRALIA CANADA CHILE COLOMBIA COLOMBIA GUATEMALA ISRAEL JAPAN NETHERLANDS POLAND SINGAPORE SOUTH KOREA UNITED ARAB EMIRATES
Questions about this recall
Is Micro-temp LT System recalled?
Yes. Cincinnati Sub-Zero Products LLC, a Gentherm recalled Micro-temp LT System on 19 Jul 2019. The recall is Class III and its status is Terminated. Recall number Z-2291-2019.
Why was it recalled?
Updated Manual-Warnigs have been added stating that exceeding 40'C for extended periods may cause tissue damage
Which lots are affected?
Serial Numbers 141-LT-02789 through 193-LT-05137 UDI: 10613031881165
Where was it sold?
Nationwide Foreign: AUSTRALIA CANADA CHILE COLOMBIA COLOMBIA GUATEMALA ISRAEL JAPAN NETHERLANDS POLAND SINGAPORE SOUTH KOREA UNITED ARAB EMIRATES
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Cincinnati Sub-Zero Products LLC, a Gentherm
All 8| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Blanketrol II Hyper-Hypothermia System recalled | Cincinnati Sub-Zero Products LLC, a Gentherm | Other | Nationwide |
| Device | CLASS II | Blanketrol III Hyper-Hypothermia System- body hypothermia recalled | Cincinnati Sub-Zero Products LLC, a Gentherm | Temperature Abuse | Nationwide |
| Device | CLASS II | CoolBlue Hyper-Hypothermia System- body hypothermia system recalled | Cincinnati Sub-Zero Products LLC, a Gentherm | Other | Nationwide |
| Device | CLASS II | Norm-O-Temp model 111W recalled by Cincinnati Sub-Zero Products | Cincinnati Sub-Zero Products LLC, a Gentherm | Device Malfunction | 36 states |
| Device | CLASS II | Norm-O-Temp model 111Z recalled by Cincinnati Sub-Zero Products | Cincinnati Sub-Zero Products LLC, a Gentherm | Device Malfunction | 36 states |
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