FDA Medical Device Recalls (openFDA)
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 number
- Z-1368-2008
- Recalling firm
- Advanced Sterilization Products
- 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.
- Status
- Terminated
- Initiated
- 2008-02-13
- Posted
- 2008-08-08
- Terminated
- 2011-11-29
- Reason
- 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).
- Root cause
- Other
- Action
- 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.
- Quantity
- 64 units
- Distribution
- Worldwide Distribution --- including USA and countries of Canada and Japan.
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K040883","K061899"]
- PMA numbers
- not on file
- Product code
- FEB
- Firm FEI
- 3003662624
- Firm city
- Irvine
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28