Facility

Sirtex Germany Manufacturing GmbH

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

Key facts

2recalls · worst Class II

1inspections · worst NAI

—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)	3013070673
Establishment type	Manufacture Medical Device
Location	Industriepark Hoechst, Building G808 Frankfurt am Main Hesse, DE 65926
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)
Inspections (1)

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

FDA inspections (1)

NAI2019-04-25
No Action Indicated · Compliance: Devices; Project Evaluation: Devices

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

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 Germany Manufacturing GmbH (FEI 3013070673) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3013070673-sirtex-germany-manufacturing-gmbh/

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