{ "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": "2026-04-08", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "country": "United States", "city": "North Haven", "address_1": "60 Middletown Ave", "reason_for_recall": "Product reportedly shutting down during use.", "address_2": "", "product_quantity": "2121", "code_info": "SIGPHANDLE-UDI #10884521543782 Serial# C17AAA0001 C17AAA0002 C17AAA0003 C17AAA0004 C17AAA0005 C17AAA0006 C17AAA0007 C17AAA0008 C17AAA0009 C17AAA0010 C17AAA0011 C17AAA0012 C17AAA0013 C17AAA0014 C17AAA0015 C17AAA0017 C17AAA0018 C17AAA0019 C17AAA0020 C17AAA0021 C17AAA0022 C17AAA0023 C17AAA0024 C17AAA0026 C17AAA0027 C17AAA0028 C17AAA0029 C17AAA0030 C17AAA0031 C17AAA0032 C17AAA0033 C17AAA0034 C17AAA0035 C17AAA0036 C17AAA0037 C17AAA0038 C17AAA0039 C17AAA0040 C17AAA0042 C17AAA0043 C17AAA0044 C17AAA0045 C17AAA0046 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C17AAK0133 C17AAK0161 C17AAK0163 C17AAK0164 C17AAK0174 C17AAK0218", "center_classification_date": "20180327", "distribution_pattern": "Worldwide Distribution: US (Nationwide).", "state": "CT", "product_description": "Signia\" Power Handle (SIGPHANDLE, SIGNVAL1 and SIGVAL20 - Kits) The Signia\" Power Handle, when used with Endo GIA\" single-use reloads and Endo GIA\" single-use reloads with Tri-Staple\" Technology, has applications in open and minimally invasive general abdominal, gynecological, pediatric, and thoracic surgery for resection, transection, and creation of anastomosis.", "report_date": "20180404", "classification": "Class II", "openfda": {}, "recalling_firm": "Covidien LLC", "recall_number": "Z-1237-2018", "initial_firm_notification": "Letter", "product_type": "Devices", "event_id": "79483", "termination_date": "20200414", "more_code_info": "", "recall_initiation_date": "20171213", "postal_code": "06473-3908", "voluntary_mandated": "Voluntary: Firm initiated", "status": "Terminated" } ] }