Use cautionMedical device recall · FDA · Published January 4, 2021
Cook Medical Ureteral Stent Set Recall: Risk of Stent Breakage
Cook Medical recalls ureteral stent sets with incorrect material that may break during use. Affected models include 7.0Fr. 22-32cm for ESWL procedures. Contact for return or replacement.
Manufactured with incorrect material, which may result in the stent being stiffer and potentially susceptible to degradation could potentially lead to breakage/fragmentation.
Take action
Contact the company
📍Recalling firmCook Inc.750 N Daniels Way · Bloomington, IN 47404-9120
“Cook Medical Ureteral Stent Set Recall: Risk of Stent Breakage.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63495-cook-medical-ureteral-stent-set-recall-risk-of-stent-breakage. Based on FDA recall #Z-0960-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0960-2021%22&limit=1).
The FDA announced on Jan. 4, 2021, that Cook Inc. is recalling Cook Medical Kwart Retro-Inject Ureteral Stent Sets due to a manufacturing defect. The hazard involves incorrect material that may cause the stents to break or fragment.
How to tell if you have it
Cook Medical Kwart Retro-Inject Ureteral Stent Set 7.0Fr. 22-32cm
UPC: 00827002148376
Lot Numbers: 13024536, 13089895, NS13089897
The hazard
The stent sets were manufactured with incorrect material, which may result in the stent being stiffer and potentially susceptible to degradation. This defect could potentially lead to breakage or fragmentation of the device.
Context
GovInfoNow's records show Cook Inc. has 38 other recalls on record since July 31, 2017. Other recent recalls include a Nov. 12, 2021, recall for mislabeling risks in Flexor Check-Flo Introducer Ansel Modification products and an Oct. 13, 2021, recall regarding black debris in Skinny Needles with Chiba Tips. Additional similar product recalls include a Nov. 26, 2025, recall for Cook Ring Transjugular Intrahepatic Access Sets due to manufacturing defects and April 2, 2026, recalls for Cook Centimeter Sizing Catheters and Cook Aurous Sizing Catheters involving marker band cracking risks.
How to tell if you have this one
Check for the model number 7.0Fr. 22-32cm on the stent packaging. Affected units have lot numbers 13024536, 13089895, or NS13089897. The stents are used in ESWL procedures for kidney stones.
Brand
Cook
Product
Cook Medical Kwart Retro-Inject Ureteral Stent Set 7.0Fr. 22-32cm -Used for retrograde injection during Extracorporeal
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Stent Model
Look for the model number 7.0Fr. 22-32cm on the stent packaging or label.
Contact Manufacturer
Reach out to Cook Medical for instructions on returning or replacing the stent.
Where it went and when
Where it was distributed
Distributed in 6 states, and outside the U.S.
Listed by the agency
Not listed
FDA distribution: “FL, KY, MD, NS, NY, PA, TX Foreign: Canada, Switzerland” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Florida, Kentucky, Maryland, New York, Pennsylvania, Texas.
Recall timeline
FDA terminated this recall 8 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0960-2021 (January 4, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0960-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.