FDA Device recall Z-1150-2013
EVOTECH Endoscope Cleaner and Reprocessor System, P/N 50004
- FDA Device
- Class II
- terminated
- Published 2013-04-24
On 2013-04-24 the FDA classified a Class II recall of EVOTECH Endoscope Cleaner and Reprocessor System, P/N 50004 by Advanced Sterilization Products, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1150-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-03-28 |
| Published | 2013-04-24 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Advanced Sterilization Products |
| Distribution | US |
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
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.
Identifiers
| code_info | Batch Numbers: 5041090177 5041090127 5041090131 5041110307 5041120049 5041120065 5041120076 5041100256 50411…Batch Numbers: 5041090177 5041090127 5041090131 5041110307 5041120049 5041120065 5041120076 5041100256 5041110157 5041120133 5040107029 5041110264 5041110265 5041110280 5041100218 5041100219 5041110018 5041110143 5041110079 5041110329 5041110212 5041120155 5041100250 5041110080 5041110174 5041110330 5041110203 5041090103 5041090110 5041100103 5041100104 5041100142 5041090184 5041090185 5041120120 5041120070 5041120073 5041120080 5040107087 5041110158 5041100189 5041100186 5041110189 5041080029 5041080063 5041120034 5041080028 5041080060 5041080064 5041100145 5041100146 5041100151 5041100268 5041120081 5040107065 5041120087 5041120116 5041110111 5041110113 5040107115 5041070037 5041110121 5041110140 5041090067 5041090167 5041090168 5041120154 5041090179 5041110177 5041110112 5041110129 5041110130 5041090069 5041110271 5041070036 5041070044 5041070045 5041090034 5041090054 5041090147 5041100192 5041090203 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1150-2013%22
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