HIGH

C.R. Bard Recalls Ureteral Stent Kit Due to Labeling Discrepancy

C.R. Bard Inc recalled 116 units of the InLay Optima Ureteral Stent Kit on November 6, 2025. The recall stems from a labeling discrepancy where the actual stent size may not match the product label. This recall affects distribution in multiple U.S. states and several countries worldwide.

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

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

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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

  1. Locate the model number on the product packaging or label.
  2. Confirm if your stent kit is Lot# NGJU4328/UDI: (01)00801741015922.
  3. 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.

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

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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Safety Assessment

Risk LevelHIGH
Severity Score
7/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product Details

Model Numbers
Lot# NGJU4328/UDI: (01)00801741015922
Affected States
ALL
Report Date
December 17, 2025
Recall Status
ACTIVE

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