{ "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": "66328", "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 the countries of EA (Europe Middle East and Asia), APAC (Asia Pacific), Japan and Canada", "recall_number": "Z-0043-2014", "product_description": "STERRAD 200 Sterilizer (Single Door), Part Number: 10201. STERRAD 200 Sterilizer (Double Door), Part Number: 10202. The STERRAD Sterilization System is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.", "product_quantity": "1,305 units total (654 units in US , 651 OUS )", "reason_for_recall": "Advanced Sterilization Products (ASP) is recalling the STERRAD 200 Sterilization System because it may emit an odor or smell into the surrounding environment that is not typical to normal operating conditions.", "recall_initiation_date": "20130918", "center_classification_date": "20131022", "termination_date": "20140411", "report_date": "20131030", "code_info": "Lot A: 0009*ENG 0003*FG 0048*FG 0050*MRB 0237*YAMATO 0239*YAMATO 0097*FSRIP 0097*FG 315*TTL 316*TTL 317*TTL 318*TTL 314*FG 325*TTL 326*TTL 334*FG 335*FG 329*TTL 345*TTL 357*FG 359*FG 358*FG 344*TTL 351*FG 347*TTL 352*TTL 348*TTL 348*FG 360*TTL 361*TTL 364*FG 362*TTL 383*YAMATO 365*TTL 368*TTL 371*FG 369*TTL 370*TTL 374*TTL 378*TTL 379*TTL 397*TTL 376*TTL 398*TTL 400*TTL 401*TTL 402*TTL 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