C.R. Bard recalled 116 units of its InLay Optima Ureteral Stent Kit on November 6, 2025. A labeling discrepancy may cause the actual stent size to differ from the labeled size. Healthcare providers and patients should stop using the device immediately.
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 6 Fr. x 30 cm, reference number 788630. The affected lot number is NGJU4327/UDI:(01)00801741015786. The product was distributed worldwide, including across several U.S. states and countries such as Canada and various European and Asian nations.
A labeling discrepancy exists where the actual size of the ureteral stent may not align with the size indicated on the label. This discrepancy poses a high risk as it may lead to improper use or implantation of the stent.
No specific incidents of injuries or adverse events have been reported associated with this recall. However, the high hazard level indicates potential risks if the device is used incorrectly.
Patients and healthcare providers must stop using the ureteral stent kit immediately. Follow the recall instructions provided by the manufacturer. Contact C.R. Bard Inc or your healthcare provider for further guidance.
For more details, visit the FDA enforcement report at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0907-2026.
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