Z-0908-2026Class II

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

Name: Z-0908-2026 BD InLay Optima Ureteral Stent Kit Size: 8 Fr. x 26 cm, Ureteral Stent Kit REF 78826
Creator: C.R. Bard Inc
Published: 2025-11-06
License: https://open.fda.gov/license/

C.R. Bard Inc / initiated 2025-11-06 / Open, Classified / root cause: labeling and UDI

FDA source

C.R. Bard Inc began a recall of BD InLay Optima Ureteral Stent Kit Size: 8 Fr. x 26 cm, Ureteral Stent Kit REF 78826 on 2025-11-06. FDA classified it as Class II and gives the reason as "Labeling discrepancy; Ureteral stent actual size may not match the actual product label". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0908-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-11-06
Posted: 2025-12-11
Recalling firm: C.R. Bard Inc
Product: BD InLay Optima Ureteral Stent Kit Size: 8 Fr. x 26 cm, Ureteral Stent Kit REF 78826
Product code: FAD Stent, Ureteral
Reason for recall: Labeling discrepancy; Ureteral stent actual size may not match the actual product label.
Root cause tag: labeling and UDI
FDA root 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).
Product codes and lots: Lot# NGJU4328/UDI: (01)00801741015922

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0908-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0905-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-12-17	2025-12-11
Z-0906-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-12-17	2025-12-11
Z-0907-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-12-17	2025-12-11
Z-0908-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-12-17	2025-12-11

Product code FAD

K043193Class IIBard Inlayoptima Ureteral Stent with SutureC.R. Bard, Inc. / cleared 2004-12-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)