Advanced Sterilization Products Recalls EVOTECH Endoscope Cleaner Systems
Advanced Sterilization Products is recalling 273 EVOTECH Endoscope Cleaner & Reprocessor Systems because they did not receive sufficient High Potential (HIPOT) DC voltage testing.
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 is classified as FDA Class II. The hazard involves a lack of electrical safety testing (HIPOT), which poses a risk of harm (electrical shock/fire) even though no injuries have been reported yet, fitting the 'High' criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Advanced Sterilization Products (ASP) has determined that a limited number of EVOTECH Endoscope Cleaner & Reprocessor Systems (P/N 50004) manufactured between 2011 and 2012 did not receive sufficient High Potential (HIPOT) DC voltage testing. The recall involves 273 units that were distributed nationwide in the United States, including DC and the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, ME, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, and WI.
The EVOTECH system is designed to automatically clean and high-level disinfect flexible, submersible video or fiber-optic endoscopes. The specific defect identified is the lack of sufficient High Potential (HIPOT) DC voltage testing, which is a standard safety test for electrical equipment. The source text does not report any illnesses, injuries, or deaths associated with this recall.
Healthcare facilities and users should check their inventory for the specific serial numbers listed in the official recall notice. If a unit is found, it should be removed from service and the manufacturer contacted for instructions on repair or replacement.
The recalled product
- Product
- EVOTECH Endoscope Cleaner & Reprocessor System, P/N 50004 Designed to automatically clean and high-level disinfect flexible, submersible video or fiber-optic endoscopes.
- Manufacturer
- Advanced Sterilization Products
- Hazard
- Affected units
- 273
Distribution
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