Class II — Potential Health Hazard

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

Endoscope ED-250XL5 Operations Manual: Cleaning Recalled by Fujifilm Medical Systems U.S.A., Inc. Due to This correction is in response to publicized reports...

Date: December 23, 2015
Company: Fujifilm Medical Systems U.S.A., Inc.
Status: Terminated
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 Fujifilm Medical Systems U.S.A., Inc. directly.

Affected Products

Endoscope ED-250XL5 Operations Manual: Cleaning, Disinfection

Quantity: 98 units

Why Was This Recalled?

This correction is in response to publicized reports of multi-drug resistant bacteria on endoscopes used for Endoscopic Retrograde Cholangiopancreatogram (ERCP) procedures.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Fujifilm Medical Systems U.S.A., Inc.

Fujifilm Medical Systems U.S.A., Inc. has 37 total recalls tracked by RecallDetector.

Related Recalls

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