Recalls / —

—#217378

Product

BD InLay Optima Ureteral Stent Kit Size: 6 Fr. x 30 cm, Ureteral Stent Kit REF 788630

FDA product code

FAD — Stent, Ureteral

Device class

Class 2

Medical specialty

Gastroenterology, Urology

510(k) numbers

K043193

Affected lot / code info

Lot# NGJU4327/UDI:(01)00801741015786

Why it was recalled

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

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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

Recalling firm

Firm

C.R. Bard Inc

Address

8195 Industrial Blvd Ne, Covington, Georgia 30014-1497

Distribution

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).

Timeline

Recall initiated

2025-11-06

Posted by FDA

2025-12-11

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #217378. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.