---
title: "SMART FLEX 9x60 BIL, 80cm The S.M.A.R.T.¿ Flex Biliary Stent System is indica... — FDA record Z-0216-2022 | Is It on Recall"
description: "There is a potential for distal tip dislodgement or separation."
url: https://isitonrecall.com/recall/fda-device-z-0216-2022-smart-flex-9x60-bil-80cm-the-s-m-a-r-t-flex-biliary-stent-system-is-indicated-for-use-in-the-palliat/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement

# SMART FLEX 9x60 BIL, 80cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation of maligna... — FDA record Z-0216-2022

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Oct 1, 2021. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **Product**: 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.
- **Reason**: There is a potential for distal tip dislodgement or separation.
- **Classification**: Class II
- **Recalling firm**: Cordis Corporation
- **Quantity**: 9 units
- **Agency-reported status**: Ongoing
- **Source record identifier**: Z-0216-2022

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0216-2022%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | Product Code: SF09060SB; Lot No. 253349 |

Match all identifying details in the current notice. A brand name alone is not enough.

## Distribution

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

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

- [California](https://isitonrecall.com/state/california/)
- [Florida](https://isitonrecall.com/state/florida/)
- [Indiana](https://isitonrecall.com/state/indiana/)
- [Louisiana](https://isitonrecall.com/state/louisiana/)
- [Ohio](https://isitonrecall.com/state/ohio/)
- [Oklahoma](https://isitonrecall.com/state/oklahoma/)
- [Texas](https://isitonrecall.com/state/texas/)

## Dates in the source

- **Report date**: Nov 24, 2021
- **Recall initiation date**: Oct 1, 2021
- **Center classification date**: Nov 12, 2021

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0216-2022%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [Cordis Corporation records](https://isitonrecall.com/brand/cordis-corporation/)