Facility

SIRTEX MEDICAL INC.

2 recall(s) on record — most severe on record: Class II.

Key facts

2recalls · worst Class II

—inspections in our data

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3012690638
Establishment type	Complaint File Establishment per 21 CFR 820.198; Develop Specifications But Do Not Manufacture At This Facility
Location	300 Unicorn Park Dr., 2nd Fl., Woburn, MA, US 01801
Registration status	Active · expires 2026
Parent company	Sirtex Medical Inc. (owner-operator 9047689)
Brand names	Syringe Shield

Activity by year

Recalls (2)

Devices registered here (1)

Holder, Syringe, Lead
Product code IWR (opens in a new tab) · Class I · Radiology · 21 CFR 892.6500

Recalls & enforcement

Class IITerminated2021-02-22
There is a potential presence of particulate matter in the D-Vial.
Class IIITerminated2013-02-27
Incorrect expiration date

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “SIRTEX MEDICAL INC. (FEI 3012690638) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3012690638-sirtex-medical-inc/

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