C.R. Bard Inc recalls BD InLay Optima Ureteral Stent Kit Size: 8 Fr. x 26 cm, Ureteral Stent Kit REF 78826

Recall date

November 6, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0908-2026

FDA classification

Class II

Brand / firm

C.R. Bard Inc

Sold / distributed

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).

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

BD InLay Optima Ureteral Stent Kit Size: 8 Fr. x 26 cm, Ureteral Stent Kit REF 78826