Boston Scientific recalls EXALT Model D Single-Use Duodenoscopes with poor image quality caused by fluid entering the lens. Affected units have specific UPC codes and batch numbers. Consumers should contact Boston Scientific for details.
Poor image quality due to fluid ingress in the lens.
Boston Scientific is recalling EXALT Model D Single-Use Duodenoscopes that may have poor image quality due to fluid entering the lens. This could affect medical procedures requiring clear imaging. The recall does not require immediate action but should be checked for affected units.
Fluid can enter the lens of the duodenoscope, causing poor image quality. This may lead to inaccurate diagnosis or treatment during medical procedures. However, the risk is not immediate or life-threatening under normal use conditions.
Medical professionals who use the EXALT Model D Single-Use Duodenoscope for procedures like endoscopy. Patients using these devices for medical treatments are at risk if the device fails during a procedure.
Check for the outer box UPC number M00542421 or M0054242CE1, inner box UPC numbers M00542420 or M0054242CE0, and specific batch numbers listed in the recall notice.
Review the outer and inner box UPC numbers and batch numbers listed in the recall notice to confirm if your device is affected.
No, the recall does not require immediate action. However, you should check if your device is affected using the provided UPC and batch numbers.
Contact Boston Scientific directly for further instructions on how to handle the affected device.
The recall states poor image quality due to fluid ingress, which does not pose a risk of serious injury under normal use conditions.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0397-2024 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0397-2024 from Boston Scientific. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
