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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

Cordis Corporation: There is a potential for distal tip dislodgement or separation.

Agency Publication Date: November 12, 2021
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Affected Products

Product: SMART FLEX 10x100 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 Code: SF10100SB; Lot No. 266586

Lot Numbers:
SF10100SB
Product: SMART FLEX 10x100 BIL, 120cm 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 Code: SF10100MB; Lot No. 271626

Lot Numbers:
SF10100MB
Product: SMART FLEX 8x60 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 Code: SF08060SB; Lot No. 266523

Lot Numbers:
SF08060SB
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.

Product Code: SF09060SB; Lot No. 253349

Lot Numbers:
SF09060SB
Product: SMART FLEX 6x120 BIL, 120cm 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 Code: SF06120MB; Lot No. 266401

Lot Numbers:
SF06120MB
Product: SMART FLEX 6x150 BIL, 120cm 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 Code: SF06150MB; Lot No. 266415, 266417, and 266419

Lot Numbers:
SF06150MB

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 88821
Status: Active
Manufacturer: Cordis Corporation
Manufactured In: United States
Units Affected: 6 products (9 units; 3 units; 26 units; 4 units; 4 units; 4 units)

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.