FDA-Device2025-12-17Class IIMISBRANDING
C.R. Bard InLay Optima ureteral stent recalled for labeling size discrepancy
What this means
C.R. Bard Inc. is recalling certain InLay Optima ureteral stent kits (6 Fr. x 14 cm, REF 787614, Lot# NGJU4163) because the actual size of the stent may not match what is printed on the package label. This discrepancy could affect proper medical placement and treatment.
- If you have received this stent kit, do not use it until you verify the actual stent size matches your patient's prescription.
- Contact C.R. Bard Inc. or your distributor with the lot number NGJU4163 for guidance.
- Report any use of this product or patient concerns to the FDA's 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
Bard InLay Optima Size: 6 Fr. x 14 cm, Ureteral Stent Kit REF 787614
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0905-2026Want 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.