FDA-Device2025-12-17Class IIMISBRANDING
BD InLay Optima Ureteral Stent Kit recalled for labeling size mismatch
LABEL MIX UPNationwide distribution
Check BD InLay Optima stent labeling
C.R. Bard Inc. is recalling a specific lot of BD InLay Optima Ureteral Stent Kits (6 Fr. x 30 cm, Ref 788630, Lot NGJU4327) because the actual stent size may not match what is printed on the product label. This discrepancy could affect proper stent selection and placement.
- If you have received or used this stent kit, verify the actual stent size matches the printed label before insertion
- Contact your supplier or C.R. Bard if you have questions about affected inventory
- Report any issues to the FDA MedWatch program
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
116 units
Manufactured in
8195 Industrial Blvd Ne, N/A, Covington, GA, United States
Products
BD InLay Optima Ureteral Stent Kit Size: 6 Fr. x 30 cm, Ureteral Stent Kit REF 788630
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0907-2026More C.R. Bard Inc recalls
- FDA-Device2026-05-27C.R. Bard Silastic Foley Catheters recalled for surface staining
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