Facility

Sirtex Singapore Manufacturing Pte Ltd

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)	3009088444
Establishment type	Manufacture Medical Device
Location	50 Science Park Road, #01-01 Singapore Central Singapore, SG 11740
Registration status	Active · expires 2026
Parent company	Sirtex Medical Inc. (owner-operator 9047689)
Brand names	SIR-Spheres Select; SIR-Spheres Select Y-90 resin microspheres; SIR-Spheres; SIR-Spheres microspheres

Activity by year

Recalls (2)

Devices registered here (1)

Microspheres Radionuclide
Product code NAW (opens in a new tab) · Class III · Unknown

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 Singapore Manufacturing Pte Ltd (FEI 3009088444) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3009088444-sirtex-singapore-manufacturing-pte-ltd/

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