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# NGJU4163/UDI: (01)00801741015403
- 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 Bard InLay Optima Ureteral Stent Kit is a medical device used to support the ureters and assist in urine flow. It is commonly used in patients undergoing urinary tract procedures.
Why This Is Dangerous
The labeling discrepancy means that the size indicated on the packaging may not correspond to the actual size of the stent. This could lead to improper implantation and complications during medical procedures.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Patients using this stent may face risks if the actual device size does not match the label, potentially leading to complications or ineffective treatment.
Practical Guidance
How to identify if yours is affected
- Check the product label for the model number REF 787614.
- Verify if your stent kit is among the recalled units based on the provided distribution information.
- Contact your healthcare provider for assistance in identifying the product.
Where to find product info
Product information, including the model number, can typically be found on the box or packaging of the ureteral stent kit.
What timeline to expect
Expect a timeline of 4-6 weeks for any processing of refunds or replacements.
If the manufacturer is unresponsive
- Contact C.R. Bard Inc. via their customer service number or website.
- Consider reaching out to the FDA for additional guidance if the manufacturer is unresponsive.
How to prevent similar issues
- Always check for recall notices on medical devices before use.
- Verify the labeling information matches the actual product before use.
- Consult with healthcare professionals regarding any concerns with medical devices.
Documentation advice
Document all communications with C.R. Bard Inc. regarding the recall, including the date and details of your contact.
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Product Details
The recalled product is Bard InLay Optima Ureteral Stent Kit, Size: 6 Fr. x 14 cm, REF 787614. The kits were distributed worldwide, including across 17 U.S. states and several countries such as Canada and the United Kingdom.
Key Facts
- Class II recall
- Affected states include AZ, CA, FL, and TX
- International distribution includes Canada and UK
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Safety Guide
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