Class 2 Device Recall Bard InLay Optima Ureteral Stent Kit

• Date Initiated by Firm: November 06, 2025
• Date Posted: December 11, 2025
• Recall Status: Open, Classified
• Recall Number: Z-0905-2026
• Recall Event ID: 97985
• 510(K)Number: K043193
• Product Classification: Stent, ureteral - Product Code FAD
• Product: Bard InLay Optima Size: 6 Fr. x 14 cm, Ureteral Stent Kit REF 787614
• Code Information: Lot# NGJU4163/UDI: (01)00801741015403
• Recalling Firm/ Manufacturer: C.R. Bard Inc; 8195 Industrial Blvd Ne; Covington GA 30014-1497
• For Additional Information Contact: BD Medical Information Services; 1800-555-7422
• Manufacturer Reason for Recall: Labeling discrepancy; Ureteral stent actual size may not match the actual product label.
• FDA Determined Cause: Under Investigation by firm
• Action: On Nov. 6, 2025, BD issued a "Urgent Medical Device Recall" Notification to consignees via regional courier service or e-mail. In addition to informing consignees about the recall, BD ask consignees to take the following actions: 1. Immediately Discontinue Use. 2. Please check all inventory locations within your institution for affected BD (C.R. Bard, Inc.) product listed in the Affected Product section below. 3.Immediately quarantine and discard all devices within your facility s control per your facility s procedures. 4. Share this notice with any users of the product within your facilities to ensure they are also aware of this Medical Device Recall (Correction). 5.If you have purchased this product through a distributor, please contact this distributor to request appropriate credit or order alternate replacement product. 6.Complete and return the attached Customer Response Form to the BD contact noted on the form confirming acknowledgement ) 7. Report any adverse health consequences experienced with the use of this product to BD. Events may also be reported to the FDA's MedWatch Adverse Event Reporting program
• Quantity in Commerce: 116 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).
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = FAD