CLASS II Device recall · Reported 17 Jun 2015 · FDA Enforcement Report
Evotech Endoscope Cleaner and Reprocessing System 220-230V recalled
Advanced Sterilization Products is recalling Evotech Endoscope Cleaner and Reprocessing System 220-230V, distributed nationwide in the US. The recall was initiated on 11 May 2015 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1715-2015
- FDA event ID
- 71209
- Recalling firm
- Advanced Sterilization Products, Irvine, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 11 May 2015
- FDA classified
- 5 Jun 2015
- Reported
- 17 Jun 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Surgical Instruments
Timeline
| 11 May 2015 | Recall initiated by company | |
| 5 Jun 2015 | Classified by FDA | +25 days |
| 17 Jun 2015 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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.
Where it was distributed
Worldwide Distribution-US (nationwide) and the countries of Australia, Singapore, Canada, and Thailand.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
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
Where was it sold?
Worldwide Distribution-US (nationwide) and the countries of Australia, Singapore, Canada, and Thailand.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 71209| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Evotech Endoscope Cleaner and Reprocessing System 208V recalled | Advanced Sterilization Products | Sterility | Nationwide |
More recalls from Advanced Sterilization Products
All 36| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Sterrad NX Sterilization System, Product recalled | Advanced Sterilization Products | Sterility | Nationwide |
| Device | CLASS II | Evotech Endoscope Cleaner and Reprocessor System 208V, Product recalled | Advanced Sterilization Products | Sterility | Nationwide |
| Device | CLASS II | Cidex OPA Solution recalled by Advanced Sterilization | Advanced Sterilization Products | Sterility | CA |
| Device | CLASS II | Cidex Activated Dialdehyde Solution/case recalled | Advanced Sterilization Products | Sterility | Nationwide |
| Device | CLASS II | Wall Chart for Sterrad 100NX System recalled by Advanced Sterilization | Advanced Sterilization Products | Sterility | Nationwide |
Other Surgical Instruments recalls
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|---|---|---|---|---|---|
| Device | CLASS II | Square Driver recalled by Think Surgical | Think Surgical | Other | Nationwide |
| Device | CLASS II | Medline surgical convenience kits labeled as: EAR recalled | Medline Industries | Packaging Defects | Nationwide |
| Device | CLASS II | Convenience Kits containing Conmed AirSeal Access Ports recalled | Medline Industries | Packaging Defects | Nationwide |
| Device | CLASS II | Medline surgical convenience kits labeled as recalled | Medline Industries | Packaging Defects | Nationwide |
| Device | CLASS II | Scout MD recalled by Merit Medical Systems | Merit Medical Systems | Other | 7 states |