Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

EXALT Model D Single-Use Duodenoscope: Outer box UPN# M00542420 & Recalled by Boston Scientific Corporation Due to Poor image quality due to fluid ingress in...

Date: September 27, 2023
Company: Boston Scientific Corporation
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Boston Scientific Corporation directly.

Affected Products

EXALT Model D Single-Use Duodenoscope: Outer box UPN# M00542420 & Outer box UPN# M0054242CE0.

Quantity: US: 586 devices & OUS: 81 devices

Why Was This Recalled?

Poor image quality due to fluid ingress in the lens.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Boston Scientific Corporation

Boston Scientific Corporation has 601 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report