Cordis Corporation: Medical Device Recall in 2021 - (Recall #: Z-0216-2022)

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:

SMART FLEX 9x60 BIL, 80cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in the biliary tree.

Product Classification:

Class II

Date Initiated: October 1, 2021

Date Posted: November 24, 2021

Recall Number: Z-0216-2022

Event ID: 88821

Reason for Recall:

There is a potential for distal tip dislodgement or separation.

Status: Ongoing

Product Quantity: 9 units

Code Information:

Product Code: SF09060SB; Lot No. 253349

Distribution Pattern:

US Distribution to states of: CA, FL, IN, LA, OH, OK, TX and OUS distribution to country of Canada.

Voluntary or Mandated:

Voluntary: Firm initiated