C.R. Bard recalled 116 units of its InLay Optima Ureteral Stent Kit on November 6, 2025. A labeling discrepancy may cause the actual size of the stent to differ from what is indicated on the label. The recall 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 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.
The recall stems from a labeling discrepancy. The actual size of the ureteral stent may not match the size indicated on the product label, potentially leading to improper use.
There have been no reported injuries or incidents associated with this recall so far. The potential risk lies in the misidentification of the stent size.
Stop using the recalled ureteral stent kit immediately. Follow the recall instructions provided by the manufacturer and contact C.R. Bard Inc or your healthcare provider for further instructions.
For assistance, contact C.R. Bard Inc. at the number provided in the recall notification letter or visit their website.
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