EVOTECH Endoscope Cleaner and Reprocessor System 208V — Class II medical device recall Z-0965-2017
Terminated recall by Advanced Sterilization Products, reported 2017-01-18, distributed nationwide. Advanced Sterilization Products (ASP) is recalling the EVOTECH Endoscope Cleaner and Reprocessor System becaus
| Recall number | Z-0965-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Advanced Sterilization Products, Irvine, CA, United States |
| Recall initiated | 2016-09-27 |
| Classified | 2017-01-09 |
| Reported by FDA | 2017-01-18 |
| Terminated | 2017-04-17 |
| Distributed | Nationwide (US) |
| Quantity | 107 units |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 10705037030958 |
| Serial numbers | 5041150187, 5041150188, 5041150189, 5041150190, 5041150191, 5041150192, 5041150193, 5041150194, 5041150195, 5041150196, 5041150197, 5041150198, 5041150199, 5041150200, 5041150201, 5041150202, 5041150203, 5041150204, 5041150205, 5041150206, 5041150207, 5041150208, 5041150209, 5041150210, 5041150211 and 80 more |
Product
EVOTECH Endoscope Cleaner and Reprocessor System 208V, Product Code: 50004 The EVOTECH ECR Endoscope Cleaner and Reprocessor, a washer/disinfector, is indicated for use with high-level disinfectant CIDEX OPA Concentrate Solution and an enzymatic detergent (CIDEZYME XTRA) to achieve cleaning and high level disinfection of heat sensitive (>60¿C} semi-critical endoscopes.
Reason for recall
Advanced Sterilization Products (ASP) is recalling the EVOTECH Endoscope Cleaner and Reprocessor System because the hose may come loose and cause a leak.
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-0965-2017. 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.