FDAFDA · Food and drugs·Recall number Z-0907-2026
BD InLay Optima Ureteral Stent Kit Size: 6 Fr. x 30 cm, Ureteral Stent Kit REF 788630
Published December 17, 2025 · Recall initiated: November 6, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Labeling discrepancy; Ureteral stent actual size may not match the actual product label.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- C.R. Bard Inc
- Distributor
- 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).
- Lot
- Lot# NGJU4327/UDI:(01)00801741015786
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.