Advanced Sterilization Products: Medical Device Recall in 2015 - (Recall #: Z-1715-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: May 11, 2015

Date Posted: June 17, 2015

Recall Number: Z-1715-2015

Event ID: 71209

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.

Status: Terminated

Product Quantity: 44 units

Code Information:

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

Distribution Pattern:

Worldwide Distribution-US (nationwide) and the countries of Australia, Singapore, Canada, and Thailand.

Voluntary or Mandated:

Voluntary: Firm initiated