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# NGJU4327/UDI:(01)00801741015786
- 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 urology to maintain the patency of the ureter. It is crucial for patients with urinary tract obstructions or those undergoing certain surgical procedures.
Why This Is Dangerous
The risk arises from a labeling error that may lead to the use of the wrong size stent. This can result in complications during medical procedures, affecting patient safety.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall affects a limited number of units, but immediate action is necessary to prevent potential complications.
Practical Guidance
How to identify if yours is affected
- Check the packaging for the lot number.
- Verify if the lot number matches NGJU4327/UDI:(01)00801741015786.
- Look for the reference number 788630 on the product.
Where to find product info
The lot number is typically found on the box or label of the product packaging.
What timeline to expect
Expect a refund or replacement processing time of about 4-6 weeks.
If the manufacturer is unresponsive
- Document all communication attempts with C.R. Bard Inc.
- Contact the FDA if there is no response after multiple attempts.
- Consider consulting legal counsel if health issues arise.
How to prevent similar issues
- Always verify packaging information before use.
- Stay informed about recalls in the medical device category.
- Consult with healthcare providers about the products being used.
Documentation advice
Keep records of the product lot number, any correspondence with the manufacturer, and any medical records related to its use.
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Product Details
The recalled product is the BD InLay Optima Ureteral Stent Kit, size 6 Fr. x 30 cm, reference number 788630. The affected lot number is NGJU4327/UDI:(01)00801741015786. The product was distributed worldwide, including across several U.S. states and countries such as Canada and various European and Asian nations.
Key Facts
- Labeling discrepancy identified
- Distributed in the U.S. and several countries
- Immediate action required to stop use
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Safety Guide
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