Sirtex Medical Limited: Medical Device Recall in 2021 - (Recall #: Z-1275-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

SIROS D-Vial Prep Set, Product Code SIR-10200 - Product Usage: intended for single use.

Product Classification:

Class II

Date Initiated: February 22, 2021

Date Posted: March 24, 2021

Recall Number: Z-1275-2021

Event ID: 87393

Reason for Recall:

There is a potential presence of particulate matter in the D-Vial.

Status: Terminated

Product Quantity: 3310

Code Information:

Lot Numbers: 1031234, 1031225, 1031227, 1031229

Distribution Pattern:

US Nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated