CardioQuip Modular Cooler-Heater — Class II medical device recall Z-0566-2024
Ongoing recall by CardioQuip, LLC, reported 2023-12-27, distributed in CA, NE, OH, PA, TX, WA. There is the potential that cooler-heater devices may contain bacterial contamination which could result in pa
| Recall number | Z-0566-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | CardioQuip, LLC, College Station, TX, United States |
| Recall initiated | 2023-10-24 |
| Classified | 2023-12-15 |
| Reported by FDA | 2023-12-27 |
| Distributed | CA, NE, OH, PA, TX, WA |
| Quantity | 2 units |
| Reason classes | microbial contamination |
| UPC / GTIN / UDI-DI | 00860000846110 |
| Lot numbers | 11160294, 11161110 |
| Model numbers | MCH-1000 |
Product
CardioQuip Modular Cooler-Heater, Model: MCH-1000(m), Power: 115V-60Hz, 16A
Reason for recall
There is the potential that cooler-heater devices may contain bacterial contamination which could result in patient infection.
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-0566-2024. 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.