AngioDynamics SafeSheath ULTRALITE 10F — Class II medical device recall Z-1329-2021
Terminated recall by Oscor, Inc., reported 2021-04-07, distributed nationwide. Potential for open seal on sterile product
| Recall number | Z-1329-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Oscor, Inc., Palm Harbor, FL, United States |
| Recall initiated | 2021-03-10 |
| Classified | 2021-04-01 |
| Reported by FDA | 2021-04-07 |
| Terminated | 2023-08-08 |
| Distributed | Nationwide (US) |
| Quantity | 500 devices |
| Reason classes | sterility, packaging |
| UPC / GTIN / UDI-DI | 25051684026298 |
| Lot numbers | DP-11759 |
| Model numbers | VI10 |
Product
AngioDynamics SafeSheath ULTRALITE 10F, Model Number VI10 - Product Usage: intended for the introduction of various types of pacing leads and catheters.
Reason for recall
Potential for open seal on sterile product
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-1329-2021. 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.