Quick Facts at a Glance
- Recall Date
- November 6, 2025
- Hazard Level
- HIGH
- Brand
- C.R. Bard
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- C.R. Bard
- Product type
- Ureteral Stent Kit
- Model numbers
- Lot# NGJU4181/UDI: (01)00801741015687
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
November 6, 2025
Reported by FDA DEVICE
December 17, 2025
RecallRadar source check
December 24, 2025
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Labeling discrepancy; Ureteral stent actual size may not match the actual product label.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact C.R. Bard Inc or your healthcare provider for instructions. Notification method: Letter
About This Product
The BD InLay Optima Ureteral Stent Kit is used in urological procedures to facilitate urine flow from the kidney to the bladder. It is critical for patients with urinary obstructions or other related medical conditions.
Why This Is Dangerous
The recall is due to a labeling discrepancy where the actual size of the ureteral stent may differ from what is printed on the label. This inconsistency could lead to improper use during medical procedures.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Consumers may face delays in medical procedures if they have to return or replace the stent kit. The high-risk classification indicates significant urgency for users to stop using the product.
Practical Guidance
How to identify if yours is affected
- Check the packaging for model number Lot# NGJU4181/UDI: (01)00801741015687.
- Verify if the stent kit has been used since the recall date.
- Consult with your healthcare provider to discuss the recall.
Where to find product info
The model number can typically be found on the product label or packaging.
What timeline to expect
Refund or replacement processing may take 4-6 weeks after returning the product.
If the manufacturer is unresponsive
- Contact C.R. Bard Inc directly for follow-up on your request.
- Document all communications and attempts to resolve the issue.
How to prevent similar issues
- Always verify product labels against official specifications before use.
- Stay updated on recalls in the medical device industry.
Documentation advice
Keep records of your purchase, any correspondence regarding the recall, and notes on your healthcare provider's recommendations.
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Product Details
The recall involves the BD InLay Optima Ureteral Stent Kit, Size: 4.7 Fr. x 26 cm, REF 788426. The stent was distributed nationwide in the U.S. and in countries including Canada, Belgium, and China.
Key Facts
- Recall date: November 6, 2025
- Quantity recalled: 4,350 units
- Distribution: Worldwide, including U.S. states and several countries
- Labeling discrepancy identified
- Immediate stop-use recommended
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Safety Guide
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