Cook Inc.: Medical Device Recall in 2020 - (Recall #: Z-2971-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: July 30, 2020

Date Posted: September 23, 2020

Recall Number: Z-2971-2020

Event ID: 86256

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.

Status: Terminated

Product Quantity: 20 units

Code Information:

Lot Number: 13060084

Distribution Pattern:

International distribution to the country of Australia.

Voluntary or Mandated:

Voluntary: Firm initiated