FDA Device recall Z-2971-2020
Cook Medical Universa Soft Ureteral Stent Sets-5 FR 26 cm Reference part Number: UFH-526 - Product Usage: Used for temporary internal drain…
- FDA Device
- Class II
- terminated
- Published 2020-09-23
On 2020-09-23 the FDA classified a Class II recall of Cook Medical Universa Soft Ureteral Stent Sets-5 FR 26 cm Reference part Number: UFH-526 - Product Usage: Used for temporary internal drain… by Cook, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2971-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-07-30 |
| Published | 2020-09-23 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Cook |
| Distribution | n/a |
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
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.
Identifiers
| code_info | Lot Number: 13060084 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2971-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.