EVOTECH Endoscope Cleaner and Reprocessor System — Class II medical device recall Z-1150-2013
Terminated recall by Advanced Sterilization Products, reported 2013-04-24, distributed nationwide. Advanced Sterilization Products (ASP) is recalling the EVOTECH Endoscope Cleaner and Reprocessor (ECR) because
| Recall number | Z-1150-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Advanced Sterilization Products, Irvine, CA, United States |
| Recall initiated | 2013-03-28 |
| Classified | 2013-04-18 |
| Reported by FDA | 2013-04-24 |
| Terminated | 2013-08-22 |
| Distributed | Nationwide (US) |
| Quantity | 761 units |
| Reason classes | device malfunction |
| Lot numbers | 5040107029, 5040107065, 5040107073, 5040107087, 5040107101, 5040107104, 5040107105, 5040107106, 5040107108, 5040107109, 5040107111, 5040107112, 5040107114, 5040107115, 5040107121, 5041070035, 5041070036, 5041070037, 5041070038, 5041070039, 5041070041, 5041070042, 5041070043, 5041070044, 5041070045, 5041070048, 5041080012, 5041080013, 5041080014, 5041080015, 5041080017, 5041080019, 5041080020, 5041080024, 5041080027, 5041080028, 5041080029, 5041080057, 5041080058, 5041080059 and 460 more |
Product
EVOTECH Endoscope Cleaner and 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) is recalling the EVOTECH Endoscope Cleaner and Reprocessor (ECR) because they have received reports of smoke emanating from the system due to a circuit board malfunction that may occur in the Channel Control Manifold sub-assembly.
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-1150-2013. 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.