FDA Device recall Z-1123-2013
EVOTECH Endoscope Cleaner & Reprocessor System, P/N 50004 Designed to automatically clean and high-level disinfect flexible, submersible vi…
- FDA Device
- Class II
- terminated
- Published 2013-04-24
On 2013-04-24 the FDA classified a Class II recall of EVOTECH Endoscope Cleaner & Reprocessor System, P/N 50004 Designed to automatically clean and high-level disinfect flexible, submersible vi… by Advanced Sterilization Products, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1123-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-03-22 |
| Published | 2013-04-24 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Advanced Sterilization Products |
| Distribution | US |
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
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.
Identifiers
| code_info | Serial Numbers: 5041110026 5041110070 5041110041 5041110082 5041110083 5041110076 5041110075 5041110078 504111…Serial Numbers: 5041110026 5041110070 5041110041 5041110082 5041110083 5041110076 5041110075 5041110078 5041110085 5041110092 5041110091 5041110077 5041110079 5041110086 5041110081 5041110084 5041110080 5041110087 5041110105 5041110099 5041110104 5041110101 5041110088 5041110106 5041110090 5041110093 5041110110 5041110108 5041110115 5041110112 5041110116 5041110114 5041110107 5041110074 5041110102 5041110111 5041110113 5041110098 5041110100 5041110071 5041110073 5041110117 5041110123 5041110122 5041110124 5041110125 5041110126 5041110109 5041110127 5041110120 5041110129 5041110130 5041110134 5041110128 5041110135 5041110143 5041110136 5041110137 5041110121 5041110140 5041110132 5041110131 5041110144 5041110145 5041110141 5041110146 5041110133 5041110142 5041110147 5041110148 5041110150 5041110151 5041110152 5041110156 5041110149 5041110157 5041110153 5041110154 5041110155 5041110158 5041110159 5041110160 |
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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-1123-2013%22
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