Cordis S.M.A.R.T
Medical device recall Z-0324-2018. Published in FDA’s Enforcement Report on Jan 17, 2018.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Jan 17, 2018. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word, and 31 states named
- 511 how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
Potential for cracked luer hubs
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Cordis S.M.A.R.T. Flex Biliary Stent System Product Usage: Is indicated for use in the palliation of malignant strictures in the biliary tree.
511, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
GTIN Catalog Lot Numbers ------------------------------------------------------------------------------------------------ 20705032065600 SF05100MB 41316 and 41352, 20705032065648 SF06100MB 41318 and 41353, 20705032065723 SF06120MB 40997…
Every code shown here, 855 characters
GTIN Catalog Lot Numbers ------------------------------------------------------------------------------------------------ 20705032065600 SF05100MB 41316 and 41352, 20705032065648 SF06100MB 41318 and 41353, 20705032065723 SF06120MB 40997 and 41354, 20705032066034 SF06150MB 41198 and 41355, 20705032065747 SF07080MB 41319, 20705032065655 SF07100MB 40999 and 41199, 20705032065617 SF07150MB 41200 and 41356, 20705032065662 SF08100MB 41320, 20705032066348 SF08120MB 41056, 20705032066171 SF09030MB 41055, 20705032066164 SF09030SB 41203, 20705032066263 SF09060MB 41003 and 41359, 20705032065938 SF09060SB 41122, 20705032066096 SF09080MB 40998, 20705032066072 SF09080SB 41004 and 41202, 20705032065778 SF09100SB 40996 and 41124, 20705032065570 SF10040SB 41322, 20705032065945 SF10060SB 41002, 20705032066089 SF10080SB 41323, and 20705032066317 SF10100MB 41058.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Worldwide Distribution - US Nationwide in the states of MI, AL, AR, CA, CO, FL, GA, IL, IA, LA, MS, NJ, NC, OH, OK, OR, PA, TN, TX, VA, WV, WI, MI, NY, MA, NV, RI, IN, WA, AZ, DC, Puerto Rico and the country of Canada.
The states and territories these words name
31 states and territories.
Every one of them
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- District of Columbia
- Florida
- Georgia
- Iowa
- Illinois
- Indiana
- Louisiana
- Massachusetts
- Michigan
- Mississippi
- North Carolina
- New Jersey
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Puerto Rico
- Rhode Island
- Tennessee
- Texas
- Virginia
- Washington
- Wisconsin
- West Virginia
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Nov 15, 2017.
- FDA classified it on Jan 9, 2018.
- FDA’s Enforcement Report published it on Jan 17, 2018.
- FDA terminated it on Nov 4, 2019.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Cordis Corporation, of Miami Lakes, FL.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.