Device recall: EVOTECH Endoscope Cleaner and Reprocessor System 208V, Product Code: 50004 The EVOTECH ECR Endoscope Cleaner and…

Class II FDA enforcement event 75290. Recall start date: 27 Sep 2016. Status in the FDA record: Terminated. Termination date: 17 Apr 2017.

Reason for recall, in the words of FDA

Advanced Sterilization Products (ASP) is recalling the EVOTECH Endoscope Cleaner and Reprocessor System because the hose may come loose and cause a leak.

Class II, in the words of FDA

a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote

Advanced Sterilization Products started this device recall on 27 Sep 2016. The firm address in the FDA record is in Irvine, CA. FDA put the recall in Class II. FDA event 75290 has 1 product record. The first FDA enforcement report date is 18 Jan 2017. The record gives the status Terminated, with the termination date 17 Apr 2017.

FDA enforcement report The 1 product record

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

US Nationwide Distribution.

Recalling firm

Advanced Sterilization Products, Irvine, CA.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

1 product record in the event.

FDA event 75290: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-0965-2017	EVOTECH Endoscope Cleaner and Reprocessor System 208V, Product Code: 50004 The EVOTECH ECR Endoscope Cleaner and Reprocessor, a washer/disinfector, is indicated for use with high-level disinfectant CIDEX OPA Concentrate Solution and an enzymatic detergent (CIDEZYME XTRA) to achieve cleaning and high level…	107 units	Class II	Terminated	18 Jan 2017

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

The event in context

Device events that started in 2016: 1,232
Share of these events in Class II: 91%
Product records in this event: 1Median of the firm: 1
Events of the firm on the register: 26

Other events of the firm

Other FDA enforcement events of Advanced Sterilization Products
Initiated	Product (first record)	Type	Class	Records
9 Jan 2017	STERRAD NX Sterilization System, Product Code: 10033, 10033-002	Device	Class II	1
10 Aug 2015	CIDEX OPA Solution, P/N 20390 for use as a high level disinfectant for reprocessing heat sensitive medical devices.	Device	Class II	1
27 Jul 2015	CIDEX Activated Dialdehyde Solution, 4 bottles/case, P/N: 2266	Device	Class II	1
17 Jul 2015	Wall Chart for STERRAD 100NX System, P/N 10104. The STERRAD 100NX Sterilizer is designed for sterilization of both metal	Device	Class II	1
11 May 2015	EVOTECH Endoscope Cleaner and Reprocessing System 208V, P/N 50004. The ASP EVOTECH ECR Endoscope Cleaner and Reprocessor	Device	Class II	2
24 Dec 2014	Tyvek Pouch/Roll with STERRAD Chemical Indicator, P/N 12425	Device	Class II	1
4 Nov 2014	STERRAD 50, Product Code 10114. The STERRAD Cassettes are used on STERRAD Sterilization System which is a low temperatur	Device	Class II	5
16 Dec 2013	STERRAD NX Sterilization System, Product Code: 10033 The STERRAD NX Sterilization System is a general purpose, low tempe	Device	Class II	3
26 Nov 2013	STERRAD Cyclesure Biological Indicator (BI, Part No. 14324. Intended to be used as a standard method for frequent monito	Device	Class II	1
11 Nov 2013	STERRAD 100NX, Product Code: 10104 The STERRAD Steri lization System is a low temperature general purpose sterilizer use	Device	Class II	2

Advanced Sterilization Products: all 26 events

Official channels

FDA enforcement report Z-0965-2017The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

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Cite this page

Recall Register. FDA enforcement event 75290. https://recallregister.com/fda/ii/75290/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA device enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: US Nationwide Distribution.
What quantity of product is in FDA event 75290?: The FDA record gives this quantity: 107 units
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2016 have the same class?: 91% of the 1,232 device events that started in 2016 are in Class II.