Class II — Potential Health Hazard

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

Custom Ultrasonics System 83 Plus 2 and Plus 9 Endoscope Washer/Disinfector. Recalled by Custom Ultrasonics, Inc. Due to Certain System 83 Plus 2 and System 83...

Date: March 12, 2013
Company: Custom Ultrasonics, 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 Custom Ultrasonics, Inc. directly.

Affected Products

Custom Ultrasonics System 83 Plus 2 and Plus 9 Endoscope Washer/Disinfector.

Quantity: 118

Why Was This Recalled?

Certain System 83 Plus 2 and System 83 Plus 9 units running the Windows 7 operating system were not fully validated prior to distribution.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Custom Ultrasonics, Inc.

Custom Ultrasonics, Inc. has 2 total recalls tracked by RecallDetector.

Related Recalls

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