FDA Enforcement
Class II
Ongoing
BD InLay Optima Ureteral Stent Kit Size: 8 Fr. x 26 cm, Ureteral Stent Kit REF 78826
Recall: Z-0908-2026
·
Reported December 17, 2025
Enforcement
- Recall Number
- Z-0908-2026
- Event ID
- 97985
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- C.R. Bard Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- December 17, 2025
- Initiation Date
- November 6, 2025
- Classification Date
- December 11, 2025
- Address
- 8195 Industrial Blvd Ne, N/A, Covington, GA, 30014-1497, United States
Description
BD InLay Optima Ureteral Stent Kit Size: 8 Fr. x 26 cm, Ureteral Stent Kit REF 78826
Reason
Labeling discrepancy; Ureteral stent actual size may not match the actual product label.
Code Info
Lot# NGJU4328/UDI: (01)00801741015922
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).
Quantity
116 units