BD InLay Optima Ureteral Stent Kit: Labeling Discrepancy Risk
C.R. Bard recalls BD InLay Optima Ureteral Stent Kit Size 6 Fr. x 30 cm (REF 788630) due to possible size mismatch with product label. Affected units may have incorrect dimensions.
Lower-risk recall
Labeling discrepancy; Ureteral stent actual size may not match the actual product label.
Contact the company
What happened, in plain English
C.R. Bard is recalling BD InLay Optima Ureteral Stent Kits (size 6 Fr. x 30 cm, REF 788630) because the actual product size might not match the label. This could lead to improper use during medical procedures. Read more at govinfonow.com/recall/50709-bd-inlay-optima-ureteral-stent-kit-labeling-discrepancy-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/50709-bd-inlay-optima-ureteral-stent-kit-labeling-discrepancy-risk · Updated August 18, 2026 · FDA enforcement record: FDA #Z-0907-2026
Cite this page
“BD InLay Optima Ureteral Stent Kit: Labeling Discrepancy Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/50709-bd-inlay-optima-ureteral-stent-kit-labeling-discrepancy-risk. Based on FDA recall #Z-0907-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0907-2026%22&limit=1).
Why it’s dangerous
The stent's actual size may differ from what's labeled, which could lead to improper placement during medical procedures. This might cause complications like blockages or incorrect treatment.
Who’s affected
Medical professionals using the ureteral stent kit for procedures. Patients receiving the stent during surgery are at risk if the size mismatch causes incorrect placement.
How to tell if you have this one
Check for the product name 'BD InLay Optima Ureteral Stent Kit', size 6 Fr. x 30 cm, and reference number REF 788630. Lot numbers starting with NGJU4327 are affected.
- Brand
C.R. Bard- Product
BD InLay Optima Ureteral Stent Kit Size: 6 Fr. x 30 cm, Ureteral Stent Kit REF 788630- Category
Medical device
All 4 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Ongoing- 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).
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-0905-2026 | Bard InLay Optima Size: 6 Fr. x 14 cm, Ureteral Stent Kit REF 787614; Lot# NGJU4163/UDI: (01)00801741015403 | 116 units |
| Z-0906-2026 | BD InLay Optima Ureteral Stent Kit Size: 4.7 Fr. x 26 cm, Ureteral Stent Kit REF 788426; Lot# NGJU4181/UDI: (01)00801741015687 | 4350 units |
| Z-0907-2026 | BD InLay Optima Ureteral Stent Kit Size: 6 Fr. x 30 cm, Ureteral Stent Kit REF 788630; Lot# NGJU4327/UDI:(01)00801741015786 | 116 units |
| Z-0908-2026 | BD InLay Optima Ureteral Stent Kit Size: 8 Fr. x 26 cm, Ureteral Stent Kit REF 78826; Lot# NGJU4328/UDI: (01)00801741015922 | 116 units |
What to do — step by step
Check Product Label
Verify the product size and reference number on the label to confirm it matches the recalled specifications.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 22 states.
FDA 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,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Arizona, California, Colorado, Florida, Georgia, Indiana, Iowa, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Missouri, New Jersey, New York, North Dakota, Ohio, Pennsylvania, South Dakota, Virginia, Washington, Wisconsin.
Recall timeline
FDA published this recall 41 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Questions people ask
Is this recall dangerous?
The recall is for a labeling discrepancy that could lead to size mismatch, but it does not pose an immediate risk of injury or serious harm.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0907-2026 (November 6, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0907-2026 to see it in context.
- Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.