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Recall Observatory FDA recall evidence

Device product

BD InLay Optima Ureteral Stent Kit Size: 4.7 Fr. x 26 cm, Ureteral Stent Kit REF 788426

Z-0906-2026

November 06, 2025

Class II

Product summary

Firm
C.R. Bard Inc
Event
Event 97985
Status
Ongoing
Classification
Class II
Quantity
4350 units
Official record key
device-enforcement:Z-0906-2026

Official wording

Reason: Labeling discrepancy; Ureteral stent actual size may not match the actual product label.

Code information: Lot# NGJU4181/UDI: (01)00801741015687

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).

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Labeling discrepancy; Ureteral stent actual size may not match the actual product label.