C.R. Bard Inc: Medical Device Recall in 2025 - (Recall #: Z-0906-2026)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: November 6, 2025

Date Posted: December 17, 2025

Recall Number: Z-0906-2026

Event ID: 97985

Reason for Recall:

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

Status: Ongoing

Product Quantity: 4350 units

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).

Voluntary or Mandated:

Voluntary: Firm initiated