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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: All serial numbers
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Custom Ultrasonics, Inc.
- Reason for Recall:
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
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.
Product Codes/Lot Numbers:
All serial numbers
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2130-2016
Related Recalls
Custom Ultrasonics System 83 Plus 2 and Plus 9 Endoscope Washer/Disinfector.
Custom Ultrasonics
Class I - Dangerous
Certain System 83 Plus 2 and System 83 Plus 9 units running the Windows 7 operating system were not fully validated prior to distribution.