PlainRecalls
FDA Devices Moderate Class II Ongoing

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

Reported: December 17, 2025 Initiated: November 6, 2025 #Z-0906-2026

Product Description

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

Reason for Recall

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

Details

Recalling Firm
C.R. Bard Inc
Units Affected
4350 units
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).
Location
Covington, GA

Frequently Asked Questions

What product was recalled?
BD InLay Optima Ureteral Stent Kit Size: 4.7 Fr. x 26 cm, Ureteral Stent Kit REF 788426. Recalled by C.R. Bard Inc. Units affected: 4350 units.
Why was this product recalled?
Labeling discrepancy; Ureteral stent actual size may not match the actual product label.
Which agency issued this recall?
This recall was issued by the FDA Devices on December 17, 2025. Severity: Moderate. Recall number: Z-0906-2026.