enFlow Disposable Cartridge with IV Extension Set — Class I medical device recall Z-1386-2019
Terminated recall by Vyaire Medical, reported 2019-07-03, distributed nationwide. Testing has demonstrated aluminum elution from the enFlow Disposable Cartridge during fluid warming.
| Recall number | Z-1386-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Vyaire Medical, Mettawa, IL, United States |
| Recall initiated | 2019-03-13 |
| Classified | 2019-06-26 |
| Reported by FDA | 2019-07-03 |
| Terminated | 2020-09-22 |
| Distributed | Nationwide (US) |
| Countries outside the US | BR, CA, CL, CO, EC, HK, HU, IL, IN, JO, KR, KW, LB, MX, MY, NL, NZ, OM, PA, PE, QA, SA, TH, TR, VN, ZA |
| Quantity | 5,782,820 units |
| Model numbers | 980202EU |
Product
enFlow Disposable Cartridge with IV Extension Set, used for intravenous warming therapy with fluid and blood solutions.
Reason for recall
Testing has demonstrated aluminum elution from the enFlow Disposable Cartridge during fluid warming.
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-1386-2019. 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.