CardioQuip — Class II medical device recall Z-0038-2022
Ongoing recall by CardioQuip, LLC, reported 2021-10-13, distributed nationwide. Labeling does not include guidance for proper water-quality maintenance and device inspection for heater coole
| Recall number | Z-0038-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | CardioQuip, LLC, College Station, TX, United States |
| Recall initiated | 2021-05-12 |
| Classified | 2021-10-06 |
| Reported by FDA | 2021-10-13 |
| Distributed | Nationwide (US) |
| Countries outside the US | BS, DE, PA, UY |
| Quantity | 369 uniyd |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00860000846134 |
| Model numbers | 2797, MCH-11TEC |
Product
CardioQuip, Modular Cooler-Heater 1000(m),Thermoelectric Cooling Lid, Model: MCH-11TEC,CE 2797, UDI: (01) 00860000846134
Reason for recall
Labeling does not include guidance for proper water-quality maintenance and device inspection for heater cooler devices.
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-0038-2022. 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.