ALung Technologies Hemolung Respiratory Assist System — Class II medical device recall Z-0938-2021
Terminated recall by Alung Technologies Inc, reported 2021-02-10, distributed nationwide. CME America BodyGuard 323 Infusion Pumps (recalled by manufacturer) is a component to the Hemolung for EUA, an
| Recall number | Z-0938-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Alung Technologies Inc, Pittsburgh, PA, United States |
| Recall initiated | 2020-12-18 |
| Classified | 2021-01-29 |
| Reported by FDA | 2021-02-10 |
| Terminated | 2021-05-17 |
| Distributed | Nationwide (US) |
| Quantity | 101 units |
| Serial numbers | A11530, A11531, A11532, A11533, A11534, A11535, A11536, A11537, A11538, A11539, A11541, A11543, A11544, A11545, A11546, A11548, A11552, A11553, A11554, A11555, A11556, A11557, A11561, A11562, A11563 and 76 more |
Product
ALung Technologies Hemolung Respiratory Assist System (RAS) with CME BodyGuard 323 Infusion Pump(EUA) - Product Usage: an off-the-shelf infusion pump and administration set to provide a 30 mL/hr continuous saline flush to the integrated blood pump bearing.
Reason for recall
CME America BodyGuard 323 Infusion Pumps (recalled by manufacturer) is a component to the Hemolung for EUA, and the infusion pump may have a delivery inaccuracy
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-0938-2021. 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.