The System 83 Plus — Class II medical device recall Z-2130-2016
Terminated recall by Custom Ultrasonics, Inc., reported 2016-07-13, distributed nationwide. To warn customers that Custom Ultrasonics, Inc. System 83 Plus AERs should not be used for cleaning and/or hig
| Recall number | Z-2130-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Custom Ultrasonics, Inc., Ivyland, PA, United States |
| Recall initiated | 2016-05-06 |
| Classified | 2016-07-06 |
| Reported by FDA | 2016-07-13 |
| Terminated | 2017-04-18 |
| Distributed | Nationwide (US) |
| Quantity | 2,345 units |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2130-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.