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

FDA device recall Z-0905-2026 · posted 2025-12-11 · Open, Classified

Recall details

Recalling firm

C.R. Bard Inc

Reason for recall

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

Action taken

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

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

FAD

Quantity affected

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, Slov

Date initiated

2025-11-06

Date posted

2025-12-11

Location

Covington, GA

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