Custom Ultrasonics System 83 Plus 2 and Plus 9 Endoscope… — Class II medical device recall Z-0426-2014
Terminated recall by Custom Ultrasonics, Inc., reported 2013-12-04, distributed nationwide. Certain System 83 Plus 2 and System 83 Plus 9 units running the Windows 7 operating system were not fully vali
| Recall number | Z-0426-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Custom Ultrasonics, Inc., Ivyland, PA, United States |
| Recall initiated | 2013-03-12 |
| Classified | 2013-11-27 |
| Reported by FDA | 2013-12-04 |
| Terminated | 2014-06-26 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, PE, SK |
| Quantity | 118 |
Product
Custom Ultrasonics System 83 Plus 2 and Plus 9 Endoscope Washer/Disinfector.
Reason for recall
Certain System 83 Plus 2 and System 83 Plus 9 units running the Windows 7 operating system were not fully validated prior to distribution.
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-0426-2014. 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.