FDAHealthNovember 6, 2025
C.R. Bard Inc — Bard InLay Optima Size: 6 Fr. x 14 cm, Ureteral Stent Kit REF 787614
⚠️ 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
- Bard InLay Optima Size: 6 Fr. x 14 cm, Ureteral Stent Kit REF 787614
- Brand
- C.R. Bard Inc
- Lot code
- NGJU4163/UDI:
Additional details
Lot# NGJU4163/UDI: (01)00801741015403
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 116 units.
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