EVOTECH Endoscope Cleaner & Reprocessor System — Class II medical device recall Z-1123-2013
Terminated recall by Advanced Sterilization Products, reported 2013-04-24, distributed nationwide. Advanced Sterilization Products (ASP) has determined that a limited number of EVOTECH ECRs manufactured betwee
| Recall number | Z-1123-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Advanced Sterilization Products, Irvine, CA, United States |
| Recall initiated | 2013-03-22 |
| Classified | 2013-04-15 |
| Reported by FDA | 2013-04-24 |
| Terminated | 2013-11-18 |
| Distributed | Nationwide (US) |
| Quantity | 273 units |
| Serial numbers | 5041110026, 5041110041, 5041110070, 5041110071, 5041110073, 5041110074, 5041110075, 5041110076, 5041110077, 5041110078, 5041110079, 5041110080, 5041110081, 5041110082, 5041110083, 5041110084, 5041110085, 5041110086, 5041110087, 5041110088, 5041110090, 5041110091, 5041110092, 5041110093, 5041110098 and 248 more |
Product
EVOTECH Endoscope Cleaner & Reprocessor System, P/N 50004 Designed to automatically clean and high-level disinfect flexible, submersible video or fiber-optic endoscopes.
Reason for recall
Advanced Sterilization Products (ASP) has determined that a limited number of EVOTECH ECRs manufactured between 2011 and 2012 did not receive sufficient High Potential (HIPOT) DC voltage testing.
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-1123-2013. 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.