C.R. Bard Inc recalls BD InLay Optima Ureteral Stent Kit Size: 8 Fr. x 26 cm

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

BD InLay Optima Ureteral Stent Kit Size: 8 Fr. x 26 cm, Ureteral Stent Kit REF 78826

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

• FDA enforcement recordOfficial FDA database entry for Z-0908-2026
• FDA 510(k) clearance · K043193The device's official FDA premarket clearance record
• FDA device classification · FADOfficial FDA classification for this device type
• CFR regulation · 21 CFR 876.4620The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find C.R. Bard IncSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.