CardioQuip Modular Cooler-Heater — Class II medical device recall Z-0438-2024
Ongoing recall by CardioQuip, LLC, reported 2023-12-13, distributed in AL, CA, CT, FL, IA, IL, IN, KY…. There is a potential for the heating-chamber to malfunction resulting in melting/burning of the heater chamber
| Recall number | Z-0438-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | CardioQuip, LLC, College Station, TX, United States |
| Recall initiated | 2023-10-19 |
| Classified | 2023-12-01 |
| Reported by FDA | 2023-12-13 |
| Distributed | AL, CA, CT, FL, IA, IL, IN, KY, NJ, PA, TX, VA, WA, WI, WV |
| Quantity | 150 units |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 00860000846110 |
| Serial numbers | 11160024, 11160025, 11160027, 11160031, 11160071, 11160075, 11160083, 11160103, 11160203, 11160204, 11160216, 11160217, 11160218, 11160270, 11160271, 11160277, 11160289, 11160290, 11160298, 11160314, 11160315, 11160316, 11160317, 11160318, 11160319 and 125 more |
| Model numbers | MCH-1000 |
Product
CardioQuip Modular Cooler-Heater, Model:MCH-1000(m), Power: 115V-60hz,16A
Reason for recall
There is a potential for the heating-chamber to malfunction resulting in melting/burning of the heater chamber components.
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-0438-2024. 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.