SIROS D-Vial Prep Set — Class II medical device recall Z-1275-2021
Terminated recall by Sirtex Medical Limited, reported 2021-03-24, distributed nationwide. There is a potential presence of particulate matter in the D-Vial.
| Recall number | Z-1275-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sirtex Medical Limited, North Ryde, New South Wales, N/A, Australia |
| Recall initiated | 2021-02-22 |
| Classified | 2021-03-18 |
| Reported by FDA | 2021-03-24 |
| Terminated | 2023-04-17 |
| Distributed | Nationwide (US) |
| Quantity | 3,310 |
| Reason classes | specification failure |
| Lot numbers | 1031225, 1031227, 1031229, 1031234 |
Product
SIROS D-Vial Prep Set, Product Code SIR-10200 - Product Usage: intended for single use.
Reason for recall
There is a potential presence of particulate matter in the D-Vial.
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-1275-2021. 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.