Recall Z-0905-2026— C.R. Bard Inc

Name: FDA recall Z-0905-2026
Creator: U.S. Food and Drug Administration
Published: 2025-11-06

Class II · Ongoing

Class II FDA medical device recall by C.R. Bard Inc, initiated 2025-11-06. It names one FDA 510(k) clearance: K043193. Product: Bard InLay Optima Size: 6 Fr. x 14 cm, Ureteral Stent Kit REF 787614. Reason: Labeling discrepancy; Ureteral stent actual size may not match the actual product label..

Recalling firm: C.R. Bard Inc
Classification: Class II
Status: Ongoing
Initiated: 2025-11-06
Firm location: Covington, GA, United States

510(k) clearances named in this recall

1 on FDA's record

K043193 — BARD INLAYOPTIMA URETERAL STENT WITH SUTUREC.R. Bard, Inc.·cleared 2004-12-07

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Bard InLay Optima Size: 6 Fr. x 14 cm, Ureteral Stent Kit REF 787614

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.