Class II — Oscor, Inc.
| Recalling firm | OSCOR INC. |
|---|---|
| Registered facility | OSCOR INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Potential for open seal on sterile product |
| Product | AngioDynamics SafeSheath ULTRALITE 10F, Model Number VI10 - Product Usage: intended for the introduction of various types of pacing leads and catheters. |
| Quantity | 500 devices |
| Distribution | US Nationwide distribution in the state of New York. |
| Initiated | 2021-03-10 |
| Classified | 2021-04-01 |
| Terminated | 2023-08-08 |
| Recall number | Z-1329-2021 |
| 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 II recall — Oscor, Inc. (Z-1329-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/87562/
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