FDAHealthNovember 6, 2025
C.R. Bard Inc — BD InLay Optima Ureteral Stent Kit Size: 8 Fr. x 26 cm, Ureteral Stent Kit REF 78826
⚠️ Labeling discrepancy; Ureteral stent actual size may not match the actual product label.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- November 6, 2025
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).
What's affected?
- Product
- BD InLay Optima Ureteral Stent Kit Size: 8 Fr. x 26 cm, Ureteral Stent Kit REF 78826
- Brand
- C.R. Bard Inc
- Lot code
- NGJU4328/UDI:
Additional details
Lot# NGJU4328/UDI: (01)00801741015922
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 116 units.
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