ASP Recalls EVOTECH Endoscope Cleaner for Connection Detection Failure
Advanced Sterilization Products is recalling EVOTECH Endoscope Cleaner and Reprocessor units because they may fail to detect disconnected endoscopes, allowing the cleaning cycle to complete without proper processing.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device failure that could lead to inadequate disinfection of semi-critical endoscopes, posing a risk of harm to patients. This aligns with the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Advanced Sterilization Products (ASP) is recalling the EVOTECH Endoscope Cleaner and Reprocessor (ECR). The device is a washer/disinfector indicated for use with high-level disinfectant CIDEX OPA Concentrate and an enzymatic detergent to achieve cleaning and high-level disinfection of heat-sensitive semi-critical endoscopes.
The recall is being issued because the device may not detect an improper endoscope connection on two channels. If an endoscope is disconnected, the system may subsequently pass the cycle without cancellation, meaning the endoscope may not be properly cleaned or disinfected.
The recall involves 825 units of the EVOTECH Endoscope Cleaner and Reprocessing System 208V, P/N 50004. These units were distributed nationwide in the United States and in Australia, Singapore, Canada, and Thailand. Users should contact Advanced Sterilization Products for further instructions on how to address this issue.
The recalled product
- 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 c
- Manufacturer
- Advanced Sterilization Products
- Affected units
- 825
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Advanced Sterilization Products under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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