Class II — Sirtex Medical Limited
| Recalling firm | Sirtex Medical Inc. |
|---|---|
| Registered facility | View this company's 4 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | There is a potential presence of particulate matter in the D-Vial. |
| Product | SIROS D-Vial Prep Set, Product Code SIR-10200 - Product Usage: intended for single use. |
| Quantity | 3310 |
| Distribution | US Nationwide distribution. |
| Initiated | 2021-02-22 |
| Classified | 2021-03-18 |
| Terminated | 2023-04-17 |
| Recall number | Z-1275-2021 |
| 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 — Sirtex Medical Limited (Z-1275-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/87393/
Alerts for Sirtex Medical Inc.
Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.
Want a one-page facility brief?
A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.