Class I — Oscor Inc.
| Recalling firm | OSCOR INC. |
|---|---|
| Registered facility | OSCOR INC. (the firm's only registered facility) |
| Classification | Class I |
| Status | Ongoing |
| Reason | Due to manufacturing issues, there is a potential for the 14Fr and 23Fr introducer sheaths to leak from the sidearm, under the sheath cap, and along the hub score lines in the hub region. |
| Product | Abiomed REF: 0052-3006, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 23F. heart pump and accessories. |
| Quantity | 32,934 units |
| Distribution | Distribution in the US state of MA |
| Initiated | 2026-06-10 |
| Classified | 2026-07-10 |
| Recall number | Z-2680-2026 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class I recall — Oscor Inc. (Z-2680-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/99102/
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