Cook Medical Universa Soft Ureteral Stent Sets-5 FR 26 cm Reference… — Class II medical device recall Z-2971-2020
Terminated recall by Cook Inc., reported 2020-09-23. Universa Soft Ureteral Stent Sets were incorrectly placed in the outer boxes labeled as Universa Firm Ureteral
| Recall number | Z-2971-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cook Inc., Bloomington, IN, United States |
| Recall initiated | 2020-07-30 |
| Classified | 2020-09-15 |
| Reported by FDA | 2020-09-23 |
| Terminated | 2021-11-04 |
| Countries outside the US | AU |
| Quantity | 20 units |
| Reason classes | labeling |
| Lot numbers | 13060084 |
| Model numbers | UFH-526 |
Product
Cook Medical Universa Soft Ureteral Stent Sets-5 FR 26 cm Reference part Number: UFH-526 - Product Usage: Used for temporary internal drainage from the ureteropelvic junction to the bladder
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2971-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.