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.
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 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.
The labeling discrepancy may lead to patients receiving a ureteral stent that does not match the actual size indicated on the label. Misidentification could potentially affect treatment outcomes and patient safety.
As of now, there have been no reported injuries or incidents directly tied to this recall. However, the hazard level is classified as high due to the potential implications of using an incorrectly sized stent.
Patients and healthcare providers should stop using the device immediately. Contact C.R. Bard Inc or your healthcare provider for further instructions.
For details on the recall, consumers can visit the website at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0908-2026.
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