Class II
Medical Device Recall: BD InLay Optima Ureteral Stent Kit Size: 4.7 Fr. x 26 cm, Ureteral Stent Kit REF 788426
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
4350 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-0906-2026
Status: ongoing
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