FDA-Device2025-12-17Class IIMISBRANDING
BD InLay Optima Ureteral Stent Kit recalled for labeling size mismatch
What this means
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
The agency's original wording
Hazard
Labeling discrepancy; Ureteral stent actual size may not match the actual product label.
Intended for
Adults
Illnesses reported
None reported
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-0907-2026Want us to check the next one for you?
We read every CPSC, FDA, USDA, and NHTSA notice and email you a plain-English Sunday brief covering your household — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.