{ "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": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "184858", "product_res_number": "Z-0876-2021", "event_date_initiated": "2020-12-11", "event_date_created": "2021-01-15", "recall_status": "Terminated", "event_date_terminated": "2022-06-21", "res_event_number": "86937", "product_code": "MEC", "product_description": "Reliance Vision Single-Chamber Washer/Disinfector - Product Usage: intended for use in the cleaning and intermediate level disinfection of soiled reusable utensils, trays, glassware, bedpans and urinals, rubber and plastic goods, simple hard-surfaced rigid surgical instruments, such as forceps and clamps, theatre shoes, and other similar and related articles found in healthcare facilities.", "code_info": "Serial 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"firm_fei_number": "1527821", "recalling_firm": "Steris Corporation", "address_1": "5960 Heisley Rd", "city": "Mentor", "state": "OH", "postal_code": "44060-1834", "additional_info_contact": "STERIS Customer Service\n800-548-4837", "reason_for_recall": "The electrical contactor component present in the drying chamber of the Reliance Vision Single-Chamber Washer/Disinfector may malfunction, potentially leading to the heating elements in the drying chamber to overheat, eventually resulting in smoke and/or fire.", "root_cause_description": "Component design/selection", "action": "On December 11, 2020, the firm distributed Urgent Medical Device Correction letters to customers. The letter informed customers that heating elements in the drying chamber may overheat, eventually resulting in smoke and/or fire.\n\nThe firm has developed an automatic shut off of the power to prevent the heating elements from overheating if this malfunction were to occur. The unit would remain \"ON\" in an alarm state, informing the user that service is required.\n\nAll affected customers will be contacted by a STERIS service technician to arrange an onsite inspection of their unit(s) and perform the correction.\n\nUsers can continue to use their devices prior to completion of the correction. Users are reminded to follow the instructions outlined in the Operator Manual should the unit alarm \"Drying Temperature Too High\" by aborting the cycle, turning off power to the unit, and contacting STERIS.\n\nIf you have questions regarding this matter, please contact Sarah Brown, Senior Product Manager, at 440-392-7571, STERIS Customer Service at 1-800-548-4873, or your local STERIS Representative.", "product_quantity": "3405", "distribution_pattern": "Worldwide distribution - US Nationwide distribution and the countries of Australia, Belgium, Brazil, Bulgaria, Canada, Chile, \nChina, Ecuador, France, Germany, Hong Kong, Ireland, Israel, \nItaly, Japan, Korea, Republic of Malaysia, Mexico, New Zealand, Panama, Portugal, Russian Federation, Saudi Arabia, \nSingapore, Spain, Switzerland, Taiwan, United Arab Emirates, \nUnited Kingdom, Venezuela.", "openfda": { "registration_number": [ "3030733800", "3043861826", "2225311", "1056339", "3015136927", "3006563173", "3006446479", "9680353", "3030516433", "3021233712", "3005273623", "3017293064", "3042250638", "3008344687", "3015977541", "3001061128", "3018520804", "3011554142", "3012776156", "3005544459", "3002821232", "3031563141", "3012006473", "3006654680", "9617134", "3030536467", "3022516928", "3027509245", "8043629", "9616031", "8021896", "3021244152", "3029300415", "9680101", "3017847344", "3010834934", "3010653034", "3010392991", "1825014", "3010208143" ], "fei_number": [ "3030733800", "3043861826", "2225311", "3015136927", "3006563173", "3006446479", "3005273623", "3030516433", "3021233712", "3017293064", "1000140463", "1000273801", "3042250638", "3008344687", "3015977541", "3001061128", "3018520804", "3011554142", "3000231474", "3012776156", "3008241044", "3004097451", "3002821232", "3031563141", "3012006473", "3000255542", "3006654680", "3030536467", "3022516928", "3027509245", "3001168737", "3021244152", "3029300415", "3017847344", "3010834934", "3002806590", "3010653034", "3010392991", "1825014", "3010208143" ], "device_name": "Disinfector, Medical Devices", "medical_specialty_description": "General Hospital", "regulation_number": "880.6992", "device_class": "2", "k_number": [ "K911120", "K081094" ] } } ] }