FDA-Device2025-12-17Class IIMISBRANDING
BD InLay Optima Ureteral Stent Kit recalled for labeling size mismatch
LABEL MIX UPNationwide distribution
Check BD InLay Optima Ureteral Stent Kit labeling
BD InLay Optima Ureteral Stent Kits (4.7 Fr. x 26 cm, Lot NGJU4181) have a labeling error—the printed size on the package may not match the actual stent inside. This affects 4,350 units distributed across multiple U.S. states and internationally. No injuries have been reported.
- If you have this product in stock, verify the actual stent size matches the label before use
- Contact your BD sales representative or medical device supplier for guidance on affected lot numbers
- Do not use stents from Lot NGJU4181 if size verification cannot be confirmed
Hazard
Labeling discrepancy; Ureteral stent actual size may not match the actual product label.
Sold states
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).
Affected count
4350 units
Manufactured in
8195 Industrial Blvd Ne, N/A, Covington, GA, United States
Products
BD InLay Optima Ureteral Stent Kit Size: 4.7 Fr. x 26 cm, Ureteral Stent Kit REF 788426
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0906-2026More C.R. Bard Inc recalls
- FDA-Device2026-05-27C.R. Bard Silastic Foley Catheters recalled for surface staining
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