FDA Device recall Z-2130-2016
The System 83 Plus, Endoscope Washer/Disinfector Designed for the simultaneous reprocessing of up to two flexible submersible endoscopes th…
- FDA Device
- Class II
- terminated
- Published 2016-07-13
On 2016-07-13 the FDA classified a Class II recall of The System 83 Plus, Endoscope Washer/Disinfector Designed for the simultaneous reprocessing of up to two flexible submersible endoscopes th… by Custom Ultrasonics, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2130-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-05-06 |
| Published | 2016-07-13 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Custom Ultrasonics |
| Distribution | US |
Product
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.
Reason
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.
Identifiers
| code_info | All serial numbers |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2130-2016%22
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