Cook recalls Universa Soft Ureteral Stent Sets (UFH-526) due to incorrect outer box labeling that may confuse with Firm Stent Sets. This could lead to improper use.
Universa Soft Ureteral Stent Sets were incorrectly placed in the outer boxes labeled as Universa Firm Ureteral Stent Set ;pouch label reflects the packaged product.
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Contact the company
📍Recalling firmCook Inc.750 N Daniels Way · Bloomington, IN 47404-9120
“Cook Universa Soft Ureteral Stent Sets Recall: Incorrect Packaging Labeling.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64595-cook-universa-soft-ureteral-stent-sets-recall-incorrect-packaging-labeling. Based on FDA recall #Z-2971-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2971-2020%22&limit=1).
Cook Inc. recalled Cook Medical Universa Soft Ureteral Stent Sets because they were incorrectly placed in outer boxes labeled as Universa Firm Ureteral Stent Sets, according to the FDA on July 30, 2020.
How to tell if you have it
Brand: Cook
Product: Cook Medical Universa Soft Ureteral Stent Sets-5 FR 26 cm
Reference part Number: UFH-526
Lot Number: 13060084
Quantity: 20 units
The hazard
The Universa Soft Ureteral Stent Sets were incorrectly placed in the outer boxes labeled as Universa Firm Ureteral Stent Set, according to the FDA. The pouch label reflects the packaged product.
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 Cook Flexor Check-Flo Introducer Ansel Modification due to mislabeling risk and an Oct. 13, 2021, recall for Cook Skinny Needle with Chiba Tip due to black debris. Other recent recalls of similar products include Bard Ureteral Stent Kit Recall (Nov. 6, 2025) and BD InLay Optima Ureteral Stent Kit: Labeling Discrepancy Risk (Nov. 6, 2025).
How to tell if you have this one
Check for the model number UFH-526 on the stent set. The outer box should say 'Soft Ureteral Stent Set' not 'Firm Ureteral Stent Set'.
Brand
Cook
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Packaging Label
Look for the model number UFH-526 on the stent set and verify the outer box label says 'Soft Ureteral Stent Set'.
How this recall unfolded
Recall timeline
FDA terminated this recall 15 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-2971-2020 (July 30, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2971-2020 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.