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 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.
A labeling discrepancy poses risks as the actual size of the ureteral stent may differ from what is indicated on the product label. This could lead to usage of an incorrect size, potentially causing complications during medical procedures.
There are no reported injuries or incidents related to this recall at this time. However, the classification is considered Class II, indicating a potential for serious injury.
Patients and healthcare providers should immediately stop using the affected device. Follow the recall instructions provided by C.R. Bard and contact your healthcare provider for further guidance.
For more details, contact C.R. Bard Inc directly or visit the FDA website at www.accessdata.fda.gov.
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