Class II

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

C.R. Bard Inc · November 6, 2025

Reason for Recall

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

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).

States Affected

NATIONWIDE

Quantity Affected

116 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-0905-2026

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.