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# NGJU4328/UDI: (01)00801741015922
- 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. These stents are vital for patients with urinary obstructions or undergoing certain surgeries.
Why This Is Dangerous
The labeling discrepancy could result in patients receiving a stent that does not fit their anatomical needs, potentially complicating treatment. Correct sizing is crucial for the effectiveness of the stent.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Consumers relying on this medical device face significant safety concerns due to the potential for improper treatment, making it essential to act quickly regarding the recall.
Practical Guidance
How to identify if yours is affected
- Locate the model number on the product packaging or label.
- Confirm if your stent kit is Lot# NGJU4328/UDI: (01)00801741015922.
- Stop using the product immediately.
Where to find product info
Check the product packaging or label for the model number and lot information.
What timeline to expect
Expect 4-6 weeks for refund processing after returning the product.
If the manufacturer is unresponsive
- Document all correspondence with C.R. Bard.
- Contact the FDA for further guidance if the issue persists.
How to prevent similar issues
- Always verify product size and specifications before use.
- Consult healthcare providers for the latest information on device recalls.
- Check for FDA updates regarding medical device recalls regularly.
Documentation advice
Keep a record of all communication regarding the recall, including emails, letters, and receipts.
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Product Details
The recalled product is the BD InLay Optima Ureteral Stent Kit, Size: 8 Fr. x 26 cm, REF 78826. The stent kit was distributed worldwide, including states such as CA, FL, NY, and countries like Canada and the UK. The product was distributed starting in 2025.
Key Facts
- Recalled product: BD InLay Optima Ureteral Stent Kit
- Quantity recalled: 116 units
- Recall date: November 6, 2025
- Hazard level: High
- Affected distribution: Worldwide
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Safety Guide
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