Z-0907-2026 Class II Ongoing
FDA device recall Z-0907-2026 was initiated by C.R. Bard Inc on November 6, 2025 and is designated Class II. Reason for recall: Labeling discrepancy; Ureteral stent actual size may not match the actual product label. The recall status is ongoing. Affected quantity: 116 units.
Recall Details
- Product Type
- Devices
- Report Date
- December 17, 2025
- Initiation Date
- November 6, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 116 units
Product Description
BD InLay Optima Ureteral Stent Kit Size: 6 Fr. x 30 cm, Ureteral Stent Kit REF 788630
Reason for Recall
Labeling discrepancy; Ureteral stent actual size may not match the actual product label.
Distribution Pattern
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).
Code Information
Lot# NGJU4327/UDI:(01)00801741015786