Sirtex Medical Inc.
2 recall(s) on record — most severe on record: Class II.
Recalls by year
- Recalls (2)
Registered facilities (4)
- Sirtex Wilmington LLC FEI 3005579300 · MA
- Sirtex Germany Manufacturing GmbH FEI 3013070673 · DE
- SIRTEX MEDICAL INC. FEI 3012690638 · MA
- Sirtex Singapore Manufacturing Pte Ltd FEI 3009088444 · SG
Recalls & enforcement
- Class IITerminated2021-02-22There is a potential presence of particulate matter in the D-Vial.
- Class IIITerminated2013-02-27Incorrect expiration date
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.
Cite this record
RegWarden. “Sirtex Medical Inc. — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-9047689-sirtex-medical-inc/
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.