Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported October 10, 2018
Hemotherm 400CE, Catalog Numbers 86022 & 86023 The Hemotherm¿ Dual Reservoir Cooler/Heater is used to lower, maintain, or raise the temperature of the water flowing through a Blood Oxygenator/Heat Exchanger that is used to cool or warm blood during cardiopulmonary bypass procedures lasting six hours or less. The Hemotherm Dual Reservoir Cooler/Heater may also be used with a hyper/hypothermia blanket under the patient to provide warming through conductive heat transfer.
Potential for membrane (control panel) switch errors leading to an inability of the device to change control settings or an unintended change to control settings.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Cincinnati Sub-Zero Products LLC, a Gentherm Company recalled Hemotherm 400CE, Catalog Numbers 86022 & 86023 The Hemotherm¿ Dual Reservoir Cooler… - a moderate-severity action.
Hemotherm 400CE, Catalog Numbers 86022 & 86023 The Hemotherm¿ Dual Reservoir Cooler… was recalled by Cincinnati Sub-Zero Products LLC, a Gentherm Company in October 10, 2018. Reason: Potential for membrane (control panel) switch errors leading to an inability of the device to change control …. Check the official notice for the remedy. Verify recall #Z-0063-2019 with the FDA Devices before acting.
The recall
Cincinnati Sub-Zero Products LLC, a Gentherm Company issued this moderate-severity FDA Devices recall-Potential for membrane (control panel) switch errors leading to an inability of the device to change control ….
- Moderate
- severity level
- 270 units
- affected scope
- Class II
- classification
- October 10, 2018
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0063-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0063-2019) was formally reported on October 10, 2018, with the manufacturer initiating the action on September 4, 2018. It is classified under Moderate severity (Class II), 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 270 units.
The documented reason for this recall is: Potential for membrane (control panel) switch errors leading to an inability of the device to change control settings or an unintended change to control settings. Distribution data in the federal record shows the product reached: US Nationwide Distribution. 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
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
270 units
Related Recalls
6
0 from same agency
Product description
Hemotherm 400CE, Catalog Numbers 86022 & 86023 The Hemotherm¿ Dual Reservoir Cooler/Heater is used to lower, maintain, or raise the temperature of the water flowing through a Blood Oxygenator/Heat Exchanger that is used to cool or warm blood during cardiopulmonary bypass procedures lasting six hours or less. The Hemotherm Dual Reservoir Cooler/Heater may also be used with a hyper/hypothermia blanket under the patient to provide warming through conductive heat transfer.
Reason for recall
Potential for membrane (control panel) switch errors leading to an inability of the device to change control settings or an unintended change to control settings.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0063-2019 |
| Date reported | October 10, 2018 |
| Date initiated | September 4, 2018 |
| Recalling firm | Cincinnati Sub-Zero Products LLC, a Gentherm Company |
| Firm location | Cincinnati, OH |
| Affected scope | 270 units |
| Distribution | US Nationwide Distribution |
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-0063-2019) 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? ▼
Hemotherm 400CE, Catalog Numbers 86022 & 86023 The Hemotherm¿ Dual Reservoir Cooler/Heater is used to lower, maintain, or raise the temperature of the water flowing through a Blood Oxygenator/Heat Exchanger that is used to cool or warm blood during cardiopulmonary bypass procedures lasting six hours or less. The Hemotherm Dual Reservoir Cooler/Heater may also be used with a hyper/hypothermia blanket under the patient to provide warming through conductive heat transfer.. Recalled by Cincinnati Sub-Zero Products LLC, a Gentherm Company. Units affected: 270 units.
Why was this product recalled? ▼
Potential for membrane (control panel) switch errors leading to an inability of the device to change control settings or an unintended change to control settings.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 10, 2018. Severity: Moderate. Recall number: Z-0063-2019.
Where was the recalled product distributed? ▼
Distribution: US Nationwide Distribution.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0063-2019) 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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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported October 10, 2018. 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.