Boston Scientific recalls EXALT Model D Single-Use Duodenoscopes with specific outer box UPNs and lots due to poor image quality from fluid entering the lens.
Poor image quality due to fluid ingress in the lens.
Boston Scientific is recalling EXALT Model D Single-Use Duodenoscopes that may have fluid entering the lens, causing poor image quality. This could lead to inaccurate medical procedures if used.
Fluid can enter the lens of the duodenoscope, causing poor image quality. This may result in inaccurate medical procedures if the device is used during endoscopic procedures.
Patients and medical professionals who own or use the recalled EXALT Model D Single-Use Duodenoscopes with specific outer box UPNs and lots are affected. Medical staff using these devices during procedures are at the highest risk.
Check the outer box for UPN numbers M00542420 or M0054242CE0. Also look for specific lot numbers listed in the recall notice.
Identify the outer box UPN number and lot numbers to confirm if your device is recalled.
The recall is due to poor image quality caused by fluid entering the lens, which could lead to inaccurate medical procedures.
Check the outer box UPN number and lot numbers to see if your device is affected. If it is, contact Boston Scientific for further instructions.
The recall states poor image quality, not a risk of serious injury. The danger level is low risk.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0396-2024 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0396-2024 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.
