C.R. Bard recalled 4,350 units of the InLay Optima Ureteral Stent Kit on November 6, 2025. The recall was initiated due to a labeling discrepancy where the actual size of the stent may not match its label. This affects distribution across the U.S. and several countries worldwide.
Labeling discrepancy; Ureteral stent actual size may not match the actual product label.
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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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.
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.
This recall is not part of a broader industry pattern.
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.
The model number can typically be found on the product label or packaging.
Refund or replacement processing may take 4-6 weeks after returning the product.
Keep records of your purchase, any correspondence regarding the recall, and notes on your healthcare provider's recommendations.
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.
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