Class IIReported 2025-12-17

Bard InLay Optima Size: 6 Fr. x 14 cm, Ureteral Stent Kit REF 787614

Recalled by C.R. Bard Inc

Reason for Recall

Labeling discrepancy; Ureteral stent actual size may not match the actual product label.

Recall Number

Z-0905-2026

Classification

Class II

Status

Ongoing

Category

device

Initiated

2025-11-06

Reported

2025-12-17

Distribution

Worldwide - US Nationwide distribution in the states of AZ, CA, CO, FL, GA, IA, IN, KY, LA, MA, MD, MI, MO, ND, NJ, NY, OH, PA, SD, VA, WA, WI and the countries of Canada, EMEA (Belgium, Denmark, Slovakia, Spain, Turkey, United Kingdom, MENA (Jordan), S Africa), Greater Asia (China).

Code Info

Lot# NGJU4163/UDI: (01)00801741015403

Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.