{ "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": "2026-04-22", "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": "65957", "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 - USA (nationwide) and internationally to RU, VE, KW, SA, HU, GB, IT, HK, IL, MX, ZA, PH, GR, AE, IN, CO, KR, AU, IN, ES, SG, MY, TH, TR, TW, SI, BE, PL, EC, CN, JP, PA, DE, VN, CL, and Switzerland, United Kingdom. Israel. Slovenia, Qatar, Panama, Venezuela.", "recall_number": "Z-2174-2013", "product_description": "STERRAD 100NX Cassettes, Product Code: 10144 The STERRAD Sterilization System is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.", "product_quantity": "1,923 units", "reason_for_recall": "The recall of the STERRAD 100NX Cassettes was initiated because Advanced Sterilization Products (ASP) does not have adequate data to support the effectiveness of the packaging's leak indicator for the entire duration of the STERRAD 100 NX System cassette's 15 month shelf life.", "recall_initiation_date": "20130725", "center_classification_date": "20130910", "termination_date": "20131127", "report_date": "20130918", "code_info": "Lot/Batch Numbers: 10104001070010*JABIL 10104001070012*JABIL 10104001070037*JABIL 10104001070038*JABIL 10104001070039*JABIL 10104001070040*JABIL 10104001070041*JABIL 10104001080027*JABIL 10104001080020*JABIL 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1041130035 1041130054 1041130028 1041130017 1041130013 1041130024 1041130018 1041130063 1041130069 1041130062 1041130023 1041130079 1041130076 1041130077 1041130078 1041130080 1041130081 1041130071 1041130073 1041130082 1041130087 1041130090 1041130091 1041130092 1041130093 1041130094 1041130095 1041130096 1041130097 1041130098 1041130100 1041130101 1041130102 1041130107 1041130108 1041130133 1041130149 1041130152 1041130162 1041130163 1041130168 1041130119 1041130147 1041130110 1041130117 1041130120 1041130124 1041130137 1041130139 1041130142 1041130160 1041130118 1041130165 1041130020 1041130134 1041130154 1041130167 1041130173 1041130174 1041130183 10104001070020*JABIL 10104001070018*JABIL 10104001070019*JABIL 10104001070021*JABIL 10104001070023*JABIL 10104001070022*JABIL 10104001070025*JABIL 10104001070026*JABIL 10104001070027*JABIL 10104001070032*JABIL 10104001070031*JABIL 10104001070035*JABIL 10104001070036* 10104001080018*JABIL 10104001080032* 10104001080024*JABIL 10104001080089*JABIL 10104001080091*JABIL 10104001080096*JABIL 10104001080064*JABIL 10104001080071*JABIL 10104001080078*JABIL 10104001080079*JABIL 10104001080079*FG 10104001070065*JABIL 10104001070062*JABIL 10104001070060*JABIL 1041070009*JABIL 1041070014*JABIL 1041070013*JABIL 1041080062* 1041070020* 1041070024* 1041070021* 1041080065* 1041080092* 1041070052* 1041080161* 1041080171* 1041080094* 1041080162* 1041080170* 1041080085* 1041070050* 1041080166* 1041080187* 1041080181* 1041080192* 1041080183*", "more_code_info": "" } ] }