Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
The System 83 Plus Recalled by Custom Ultrasonics, Inc. Due to To warn customers that Custom Ultrasonics, Inc. System...
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
The System 83 Plus, Endoscope Washer/Disinfector Designed for the simultaneous reprocessing of up to two flexible submersible endoscopes that are used in the gastrointestinal and/or pulmonary tracts.
Quantity: 2,345 units
Why Was This Recalled?
To warn customers that Custom Ultrasonics, Inc. System 83 Plus AERs should not be used for cleaning and/or high-level disinfection of duodenoscopes until further notice.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Custom Ultrasonics, Inc.
Custom Ultrasonics, Inc. has 2 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report