ASP Recalls EVOTECH Endoscope Cleaner Due to Hose Leak Risk
Advanced Sterilization Products is recalling 107 EVOTECH Endoscope Cleaner and Reprocessor Systems because a hose may come loose and cause a leak.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. The specific hazard is a mechanical leak, which is a moderate risk without reported injuries or fatalities.
Plain-English summary
Advanced Sterilization Products (ASP) is recalling 107 units of the EVOTECH Endoscope Cleaner and Reprocessor System, 208V (Product Code: 50004). The recall was initiated because the hose on the device may come loose, which can cause a leak.
The affected units were distributed nationwide in the United States. The EVOTECH ECR Endoscope Cleaner and Reprocessor is a washer/disinfector indicated for use with high-level disinfectant CIDEX OPA Concentrate Solution and an enzymatic detergent (CIDEZYME XTRA) to achieve cleaning and high-level disinfection of heat-sensitive semi-critical endoscopes.
Users should check their device serial numbers against the list provided in the official recall notice to determine if their unit is affected. If the serial number matches, the device should be removed from service and the manufacturer contacted for instructions on repair or replacement.
The recalled product
- Product
- EVOTECH Endoscope Cleaner and Reprocessor System 208V, Product Code: 50004 The EVOTECH ECR Endoscope Cleaner and Reprocessor, a washer/disinfector, is indicated for use with high-level disinfectant CIDEX OPA Concentrate Solution and an enzymatic detergent (CIDEZYME XTRA) to…
- Manufacturer
- Advanced Sterilization Products
- Hazard
- Affected units
- 107
Distribution
Distributed nationwide across the United States.
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