FDA Device recall Z-1714-2015
EVOTECH Endoscope Cleaner and Reprocessing System 208V, P/N 50004
- FDA Device
- Class II
- terminated
- Published 2015-06-17
On 2015-06-17 the FDA classified a Class II recall of EVOTECH Endoscope Cleaner and Reprocessing System 208V, P/N 50004 by Advanced Sterilization Products, citing advanced Sterilization Products (ASP) is recalling the EVOTECH Endoscope Cleaner and Reprocessor (ECR) because it may not detect an improper endoscope connection on two channels,….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1714-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-05-11 |
| Published | 2015-06-17 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Advanced Sterilization Products |
| Distribution | US |
Product
EVOTECH Endoscope Cleaner and Reprocessing System 208V, P/N 50004. The ASP EVOTECH ECR Endoscope Cleaner and Reprocessor is a washer/disinfector, which is indicated for use with high-level disinfectant CIDEX OPA Concentrate and an enzymatic detergent (CIDEZYME Gl) to achieve cleaning and high level disinfection of heat sensitive (>60 ¿C) semi-critical endoscopes.
Reason
Advanced Sterilization Products (ASP) is recalling the EVOTECH Endoscope Cleaner and Reprocessor (ECR) because it may not detect an improper endoscope connection on two channels, and subsequently pass the cycle without cancellation if there is a disconnected scope.
Identifiers
| code_info | 5040107065 5040107073 5040107104 5040107105 5040107106 5040107109 5040107111 5040107112 5040107114 5040107115…5040107065 5040107073 5040107104 5040107105 5040107106 5040107109 5040107111 5040107112 5040107114 5040107115 5040107121 5041070036 5041070037 5041070038 5041070039 5041070043 5041070044 5041070045 5041070048 5041080013 5041080014 5041080020 5041080057 5041080059 5041080061 5041080062 5041080065 5041080066 5041080068 5041080069 5041080070 5041080071 5041080072 5041080073 5041080074 5041080077 5041090022 5041090023 5041090024 5041090028 5041090031 5041090034 5041090053 5041090054 5041090056 5041090057 5041090058 5041090060 5041090062 5041090064 5041090065 5041090066 5041090067 5041090068 5041090069 5041090070 5041090086 5041090087 5041090090 5041090092 5041090093 5041090096 5041090098 5041090099 5041090100 5041090103 5041090104 5041090105 5041090106 5041090107 5041090108 5041090109 5041090110 5041090112 5041090113 5041090121 5041090122 5041090123 5041090124 5041090125 5041090126 5041090128 5041090130 5041 |
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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-1714-2015%22
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