Medtronic HY8M63R4 — Class II medical device recall Z-1872-2021
Terminated recall by Medtronic Perfusion Systems, reported 2021-06-23, distributed nationwide. Specific lots may have been manufactured with insufficient or incomplete welds.
| Recall number | Z-1872-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Perfusion Systems, Brooklyn Park, MN, United States |
| Recall initiated | 2021-04-29 |
| Classified | 2021-06-16 |
| Reported by FDA | 2021-06-23 |
| Terminated | 2023-03-20 |
| Distributed | Nationwide (US) |
| Quantity | 2 tubing |
| UPC / GTIN / UDI-DI | 00643169921948 |
| Lot numbers | 221058527 |
| Expiration dates | 2022-10-30 |
Product
Medtronic HY8M63R4, Custom Pack HY8M63R4 Adult ECC, Custom Perfusion System, Sterile, Rx.
Reason for recall
Specific lots may have been manufactured with insufficient or incomplete welds.
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-1872-2021. 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.