Merge Hemo — Class II medical device recall Z-2387-2021
Terminated recall by Merge Healthcare, Inc., reported 2021-09-08. The firm identified a safety issue affecting the software associated with Merge Hemo versions 9.x and 10.x, us
| Recall number | Z-2387-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Merge Healthcare, Inc., Hartland, WI, United States |
| Recall initiated | 2021-07-23 |
| Classified | 2021-08-28 |
| Reported by FDA | 2021-09-08 |
| Terminated | 2023-08-29 |
| Quantity | 326 units |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 00842000100430, 00842000100874, 00842000100966 |
Product
Merge Hemo, Software packages 10.2, 10.3, and 10.4
Reason for recall
The firm identified a safety issue affecting the software associated with Merge Hemo versions 9.x and 10.x, used in combination with an HL7 lab interface.
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-2387-2021. 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.