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Home › FDA recalls › BD InLay Optima Ureteral Stent Kit Size: 6 Fr. x 30 cm
CLASS II · ModerateFDA

C.R. Bard Inc recalls BD InLay Optima Ureteral Stent Kit Size: 6 Fr. x 30 cm

📅 Nov 6, 2025 · 📍 Nationwide
Recalling company
C.R. Bard Inc
Product
BD InLay Optima Ureteral Stent Kit Size: 6 Fr. x 30 cm, Ureteral Stent Kit REF 788630
Reason
Labeling discrepancy; Ureteral stent actual size may not match the actual product label.
Classification
Class II – may cause temporary or medically reversible health consequences
Recall date
Nov 6, 2025
Reported
Dec 17, 2025
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).
Status
Ongoing
Quantity
116 units
Lot / codes
Lot# NGJU4327/UDI:(01)00801741015786
Company location
Covington, GA
Recall type
Voluntary: Firm initiated
Recall number
Z-0907-2026
Agency
U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-0907-2026 in the FDA Enforcement Report. Also see FDA recall press releases.

If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.