Bard InLay Optima Ureteral Stent recallZ-0907-2026 · C.R. Bard Inc · initiated Nov 6, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from C.R. Bard Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Labeling discrepancy; Ureteral stent actual size may not match the actual product label.
FDA root cause category: Under Investigation by firm
What the company is doing
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
Recall details
- Recall number
- Z-0907-2026
- Status
- Open, Classified
- Initiated by the company
- Nov 6, 2025
- Posted by the FDA
- Dec 11, 2025
- Recalling firm
- C.R. Bard Inc
- Quantity
- 116 units
- Product code
- FAD
- FDA submissions
- K043193
- 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 description
BD InLay Optima Ureteral Stent Kit Size: 6 Fr. x 30 cm, Ureteral Stent Kit REF 788630
Code information (models, lots, serial numbers)
Lot# NGJU4327/UDI:(01)00801741015786
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Bard® InLay Optima® Ureteral Stent 788630C. R. Bard, Inc. · STENT, URETERAL1 recall1 report
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 97985).
- Z-0906-2026 · Open, ClassifiedBD InLay Optima Ureteral Stent Kit Size: 4.7 Fr. x 26 cm, Ureteral Stent Kit REF 788426
- Z-0908-2026 · Open, ClassifiedBD InLay Optima Ureteral Stent Kit Size: 8 Fr. x 26 cm, Ureteral Stent Kit REF 78826
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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