Advanced Sterilization Products EvoTech Endoscope Cleaner & Reprocessor, Product Code 50004 Indicated for use with high level disinfectant CIDEX OPA Concentrate and an enzymatic detergent, CIDEZYME GI, to achieve cleaning and high level disinfection of heat sensitive semi-critical endoscopes. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
EvoTech Endoscope Cleaner & Reprocessor, Product Code 50004 Indicated for use with high level disinfectant CIDEX OPA Concentrate and an enzymatic detergent, CIDEZYME GI, to achieve cleaning and high level disinfection of heat sensitive semi-critical endoscopes.
Brand
Advanced Sterilization Products
Lot Codes / Batch Numbers
Product Code 50004, Serial Numbers: 50004001070080, 50004001070082, 50004001070083, 50004001070043, 50004001070044, 50004001070046, 50004001070048, 50004001070023, 50004001070024, 50004001070021, 50004001070075, 50004001070045, 50004001070078, 50004001070079, 50004001070107, 50004001070110, 50004001070081, 50004001070062, 50004001070064, 50004001070063, 50004001070034, 50004001070025, 50004001070029, 50004001070047, 50004001070049, 50004001070061, 50004001070087, 50004001070088, 50004001070084, 50004001070077, 50004001070076, 50004001070085, 50004001070086, 50004001070090, 50004001070091, 50004001070094, 50004001070089, 50004001070092, 50004001070098, 50004001070097, 50004001070099, 50004001070100, 50004001070101, 50004001070105, 50004001070106, 50004001070108, 50004001070109, 50004001070102, 50004001070103, 50004001070104, 50004001070020, 50004001070031, 50004001070035, 50004001070036, 50004001070039, 50004001070042, 50004001070059, 50004001070065, 50004001070071, 50004001070072, 50004001070073, 50004001070074, 50004001070114
Products Sold
Product Code 50004; Serial Numbers: 50004001070080, 50004001070082, 50004001070083, 50004001070043, 50004001070044, 50004001070046, 50004001070048, 50004001070023, 50004001070024, 50004001070021, 50004001070075, 50004001070045, 50004001070078, 50004001070079, 50004001070107, 50004001070110, 50004001070081, 50004001070062, 50004001070064, 50004001070063, 50004001070034, 50004001070025, 50004001070029, 50004001070047, 50004001070049, 50004001070061, 50004001070087, 50004001070088, 50004001070084, 50004001070077, 50004001070076, 50004001070085, 50004001070086, 50004001070090, 50004001070091, 50004001070094, 50004001070089, 50004001070092, 50004001070098, 50004001070097, 50004001070099, 50004001070100, 50004001070101, 50004001070105, 50004001070106, 50004001070108, 50004001070109, 50004001070102, 50004001070103, 50004001070104, 50004001070020, 50004001070031, 50004001070035, 50004001070036, 50004001070039, 50004001070042, 50004001070059, 50004001070065, 50004001070071, 50004001070072, 50004001070073, 50004001070074, 50004001070114
Advanced Sterilization Products is recalling EvoTech Endoscope Cleaner & Reprocessor, Product Code 50004 Indicated for use with high level disin due to Cleaning cycles are being cancelled. Specific issues are: a) Water heater tank is rusting resulting in the in-line 0.2 micron filter prematurely clo. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Cleaning cycles are being cancelled. Specific issues are: a) Water heater tank is rusting resulting in the in-line 0.2 micron filter prematurely clogging, b) Interface board malfunction resulting in a premature lid opening, and c) Minor fluid leaks within the system (commonly at the 0.2 micron filter attachment points).
Recommended Action
Per FDA guidance
Feburary 13, 2008 ASP issued an Urgent Product Recall Letter. ASP recommends that customers use an alternative reprocessing method until they return the system. However, if they do not have an alternate method for processing endoscopes and choose to continue using the EvoTech ECR System during this time, endoscopes processed through completed cycles in accordance with the User's Guide will be appropriately cleaned and highlevel disinfected. ASP is prepared to tailor an alternative solution to minimize the interruption to the customer's processing needs.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026