Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported July 28, 2021
Hemotherm CE Dual Reservoir Cooler/Heater, Model 400CE, 115V Model, part no. 86022. Used to cool or warm blood during cardiopulmonary bypass procedures
There is a potential risk of device contamination and patient infection associated with the device because of the potential for organisms (including Nontuberculous mycobacteria NT…
Gentherm Medical, LLC recalled Hemotherm CE Dual Reservoir Cooler/Heater, Model 400CE, 115V Model, part no. 86022. Used… - a moderate-severity action.
Hemotherm CE Dual Reservoir Cooler/Heater, Model 400CE, 115V Model, part no. 86022. Used… was recalled by Gentherm Medical, LLC in July 28, 2021. Reason: There is a potential risk of device contamination and patient infection associated with the device because of…. Check the official notice for the remedy. Verify recall #Z-2092-2021 with the FDA Devices before acting.
The recall
Gentherm Medical, LLC issued this moderate-severity FDA Devices recall-There is a potential risk of device contamination and patient infection associated with the device because of….
- Moderate
- severity level
- 1K units
- affected scope
- Class II
- classification
- July 28, 2021
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2092-2021 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2092-2021) was formally reported on July 28, 2021, with the manufacturer initiating the action on June 17, 2021. It is classified under Moderate severity (Class II), with a current status of Terminated. Gentherm Medical, LLC is listed as the recalling firm, operating out of Blue Ash, OH. Federal records list the affected scope as 1448 devices (1010 US; 438 OUS).
The documented reason for this recall is: There is a potential risk of device contamination and patient infection associated with the device because of the potential for organisms (including Nontuberculous mycobacteria NTM) to grow in the water systems of any h… Distribution data in the federal record shows the product reached: Worldwide distribution. US nationwide, including Puerto Rico; Argentina, Bangladesh, Chile, Colombia, France, Guatemala, Hungary, India, Indonesia, Israel, Italy, Nepal, Nigeria, Pakistan, Philippines, Romania, Saudi …. 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, 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 - 40,861 medical devices recalls on record
Of 88,001 recalls with an agency hazard classification, 19,020 are high severity, 64,468 moderate, and 4,513 low. A further 16,157 CPSC/NHTSA recalls have no agency class and are excluded from this split. 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
1448 devices (1010 US; 438 OUS)
Related Recalls
6
6 from same agency
Product description
Hemotherm CE Dual Reservoir Cooler/Heater, Model 400CE, 115V Model, part no. 86022. Used to cool or warm blood during cardiopulmonary bypass procedures
Reason for recall
There is a potential risk of device contamination and patient infection associated with the device because of the potential for organisms (including Nontuberculous mycobacteria NTM) to grow in the water systems of any heater-cooler device, and contaminated water from any heater-cooler device has the potential to aerosolize into the operating room during surgery which could lead to patient infection.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2092-2021 |
| Date reported | July 28, 2021 |
| Date initiated | June 17, 2021 |
| Recalling firm | Gentherm Medical, LLC |
| Firm location | Blue Ash, OH |
| Affected scope | 1448 devices (1010 US; 438 OUS) |
| Distribution | Worldwide distribution. US nationwide, including Puerto Rico; Argentina, Bangladesh, Chile, Colombia, France, Guatemala, Hungary, India, Indonesia, Israel, Italy, Nepal, Nigeria, Pakistan, Philippines, Romania, Saudi Arabia, Singapore, S… |
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-2092-2021) 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 CE Dual Reservoir Cooler/Heater, Model 400CE, 115V Model, part no. 86022. Used to cool or warm blood during cardiopulmonary bypass procedures. Recalled by Gentherm Medical, LLC. Units affected: 1448 devices (1010 US; 438 OUS).
Why was this product recalled? ▼
There is a potential risk of device contamination and patient infection associated with the device because of the potential for organisms (including Nontuberculous mycobacteria NTM) to grow in the water systems of any heater-cooler device, and contaminated water from any heater-cooler device has the potential to aerosolize into the operating room during surgery which could lead to patient infection.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 28, 2021. Severity: Moderate. Recall number: Z-2092-2021.
Where was the recalled product distributed? ▼
Distribution: Worldwide distribution. US nationwide, including Puerto Rico; Argentina, Bangladesh, Chile, Colombia, France, Guatemala, Hungary, India, Indonesia, Israel, Italy, Nepal, Nigeria, Pakistan, Philippines, Romania, Saudi Arabia, Singapore, South Africa, South Korea, Switzerland, Taiwan, Thailand, Turkey, UAE.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2092-2021) 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.
Nearby Recalls in This Category
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
FDA Devices Moderate
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Penumbra System RED 68 Reperfusion Catheter REF: RED68KIT
Penumbra, Inc. · 2026-07-29
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Compare this recall with FARADRIVE STEERABLE SHEATH CLEAR, used to facilitate access… →
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 July 28, 2021. 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 August 2026.