Class II — Advanced Sterilization Products
| Recalling firm | Advanced Sterilization Products |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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. |
| 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. |
| Quantity | 761 units |
| Distribution | Nationwide Distribution |
| Initiated | 2013-03-28 |
| Classified | 2013-04-18 |
| Terminated | 2013-08-22 |
| Recall number | Z-1150-2013 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Advanced Sterilization Products (Z-1150-2013).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/64781/
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