FDA applicant

Sirtex Medical, Inc.

Woburn2 decisions2002–20231 recall

FDA records 2 decisions for Sirtex Medical, Inc. (Woburn) from 2002 to 2023: 2 original PMA approvals. Most are in product codes NAW (Microspheres Radionuclide) and QVG (Embolization Agent, Vascular). 1 recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, radiology panel, where it files most

How often FDA has decided Sirtex Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2007high 1 (2023) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2013

2007high 1 (2013) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Sirtex Medical, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Sirtex”

FDA records each applicant name separately; these may or may not be the same firm.

Sirtex Medical US Holdings, Inc. 1

Sirtex Medical, Inc.

Which product codes does it file in?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Sirtex”