Labeling discrepancy; Ureteral stent actual size may not match the actual product label.
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Recall Number
Z-0907-2026
Classification
Class II
Status
Ongoing
Category
device
Initiated
2025-11-06
Reported
2025-12-17
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).
Code Info
Lot# NGJU4327/UDI:(01)00801741015786
Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.