Z-1715-2015Class II

EVOTECH Endoscope Cleaner and Reprocessing System 220-230V, P/N 50004-002. The ASP EVOTECH ECR Endoscope...

Name: Z-1715-2015 EVOTECH Endoscope Cleaner and Reprocessing System 220-230V, P/N 50004-002. The ASP EVOTECH ECR Endoscope...
Creator: Advanced Sterilization Products
Published: 2015-05-11
License: https://open.fda.gov/license/

Advanced Sterilization Products / initiated 2015-05-11 / Terminated / root cause: manufacturing process

FDA source

Advanced Sterilization Products began a recall of EVOTECH Endoscope Cleaner and Reprocessing System 220-230V, P/N 50004-002. The ASP EVOTECH ECR Endoscope Cleaner and Reprocessor is a washer/disinfector, which... on 2015-05-11. FDA classified it as Class II and gives the reason as "Advanced Sterilization Products (ASP) is recalling the EVOTECH Endoscope Cleaner and Reprocessor (ECR) because it may not detect an improper endoscope connection on two channels, and subsequently pass the cycle without...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1715-2015
Classification: Class II
Status: Terminated
Initiated: 2015-05-11
Posted: 2015-06-05
Terminated: 2016-07-06
Recalling firm: Advanced Sterilization Products
Product: EVOTECH Endoscope Cleaner and Reprocessing System 220-230V, P/N 50004-002. 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 cleaning and high level disinfection of heat sensitive (>60 C) semi-critical endoscopes.
Product code: FEB Accessories, Cleaning, For Endoscope
Reason for recall: Advanced Sterilization Products (ASP) is recalling the EVOTECH Endoscope Cleaner and Reprocessor (ECR) because it may not detect an improper endoscope connection on two channels, and subsequently pass the cycle without cancellation if there is a disconnected scope.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: A customer notification letter dated 5/7/15 will be sent to all customers on 5/13/15 to inform them that ASP is recalling the EVOTECH Endoscope Cleaner and Reprocessor (ECR) because it may not detect an improper endoscope connection on two channels and subsequently pass the cycle without cancellation if there is a disconnected scope. The letter informs the customers of the problems identified and the actions to be taken. Customers are instructed to complete and return the attached Business Reply Card (double-sided) via mail or by fax to Stericycle: 888-879-8144. Customers with questions regarding the business reply card are instructed to contact Stericycle at 888-345-4671 and reference event #7781.
Quantity in commerce: 44 units
Distribution: Worldwide Distribution-US (nationwide) and the countries of Australia, Singapore, Canada, and Thailand.
Product codes and lots: 5040207003 5040207004 5040308003 5042100008 5042100016 5042100017 5042100018 5042100019 5042100020 5042100021 5042100022 5042100023 5042100024 5042100025 5042100033 5042100034 5042100035 5042100036 5042100037 5042100038 5042100039 5042100040 5042100060 5042100061 5042100063 5042100064 5042100065 5042100066 5042100067 5042110002 5042110003 5042110004 5042110005 5042110006 5042120002 5042120006 5042130009 5042130011 5042140029 5042140030 5042140031 5042140032 5042140038 5042140039

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1715-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1714-2015	Class II	Terminated	Voluntary: Firm initiated	2015-06-17	2015-06-05
Z-1715-2015	Class II	Terminated	Voluntary: Firm initiated	2015-06-17	2015-06-05

Product code FEB

K140977Class IIEvotech EcrAdvanced Sterilization Products / cleared 2014-12-22

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)