Heater Cooler Unit — Class II medical device recall Z-2140-2021
Terminated recall by Maquet Medical Systems USA, reported 2021-08-04, distributed in AL, CA, FL, IL, KS, MI, MO, NC…. There is the potential for contaminated water to enter parts of the Heater-Cooler Unit circuits. There is a po
| Recall number | Z-2140-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Maquet Medical Systems USA, Wayne, NJ, United States |
| Recall initiated | 2021-07-14 |
| Classified | 2021-07-23 |
| Reported by FDA | 2021-08-04 |
| Terminated | 2022-08-03 |
| Distributed | AL, CA, FL, IL, KS, MI, MO, NC, NE, OH |
| Quantity | 33 |
| Reason classes | microbial contamination |
| Model numbers | 70102.8718, 70103.4371HCU, 70103.4653HCU, 704629I, 705501I, 939001I |
Product
Heater Cooler Unit (HCU 30) The device supplies temperature-controlled water for cardioplegia heat exchangers and for blood heat exchangers in extracorporeal circulation and for blankets with which patients can be warmed or cooled.
Reason for recall
There is the potential for contaminated water to enter parts of the Heater-Cooler Unit circuits. There is a potential risk of bacterial contamination including Mycobacteria species.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2140-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.