The Recall Desk

Manufacturer

Sirtex Medical Limited

2 recalls in our database name Sirtex Medical Limited as the manufacturing or recalling firm.

What the numbers show

Total
2
Critical
0
Severe
0
Most recent
2021-03-24

Of the 2 recalls from Sirtex Medical Limited we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–2 of 2

  • HighFDA (Devices)·Z-1275-2021·2021-03-24

    Sirtex Medical Recalls SIROS D-Vial Prep Sets Due to Particulate Matter

    Sirtex Medical Limited is recalling SIROS D-Vial Prep Sets because of a potential presence of particulate matter in the D-Vial.

    Product
    SIROS D-Vial Prep Set, Product Code SIR-10200 - Product Usage: intended for single use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1162-2013·2013-05-01

    Sirtex SIR-yttrium 90 microspheres recalled for incorrect expiration date

    Sirtex Medical Limited is recalling 21 doses of SIR-yttrium 90 microspheres due to an incorrect expiration date. The product is used to treat unresectable metastatic liver tumors.

    Product
    Sirtex SIR-yttrium 90 microspheres (Radionuclide); SIR-Y001. Indicated for the treatment of unresectable metastatic liver tumors.
    Category
    Medical Device
    Distribution
    Distributed nationwide