Class III — Low Risk

Low risk — use of or exposure to this product is not likely to cause adverse health consequences.

EXALT Controller - Product Usage: intended for use with a Recalled by Boston Scientific Corporation Due to May have been programmed with a less than...

Date: March 16, 2021
Company: Boston Scientific Corporation
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 Boston Scientific Corporation directly.

Affected Products

EXALT Controller - Product Usage: intended for use with a Boston Scientific endoscope for endoscopic diagnosis, treatment, and video observation. UPN: M00542430

Quantity: 3 units

Why Was This Recalled?

May have been programmed with a less than optimal brightness setting resulting in a darker than desired image

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