{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-04-15", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "status": "Terminated", "city": "Irvine", "state": "CA", "country": "United States", "classification": "Class II", "openfda": {}, "product_type": "Devices", "event_id": "71209", "recalling_firm": "Advanced Sterilization Products", "address_1": "33 Technology Dr", "address_2": "N/A", "postal_code": "92618-2346", "voluntary_mandated": "Voluntary: Firm initiated", "initial_firm_notification": "Letter", "distribution_pattern": "Worldwide Distribution-US (nationwide) and the countries of Australia, Singapore, Canada, and Thailand.", "recall_number": "Z-1714-2015", "product_description": "EVOTECH Endoscope Cleaner and Reprocessing System 208V, P/N 50004. 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_quantity": "825 units", "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.", "recall_initiation_date": "20150511", "center_classification_date": "20150605", "termination_date": "20160706", "report_date": "20150617", "code_info": "5040107065 5040107073 5040107104 5040107105 5040107106 5040107109 5040107111 5040107112 5040107114 5040107115 5040107121 5041070036 5041070037 5041070038 5041070039 5041070043 5041070044 5041070045 5041070048 5041080013 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