{ "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": "Bloomington", "state": "IN", "country": "United States", "classification": "Class II", "openfda": {}, "product_type": "Devices", "event_id": "82904", "recalling_firm": "Cook Inc.", "address_1": "750 N Daniels Way", "address_2": "N/A", "postal_code": "47404-9120", "voluntary_mandated": "Voluntary: Firm initiated", "initial_firm_notification": "Letter", "distribution_pattern": "No US distribution. Product distributed to the following foreign countries: Australia, Austria, Belgium, Brazil, Canada, Canary Islands, Chile Columbia, Costa Rica, Czech Republic, Denmark, Finland, France, Germany, Greece, Ireland, Israel, Italy, Japan, Morocco, Netherlands, Norway, Poland, Portugal, Reunion, Serbia, Slovakia, South Africa, Spain, Sweden, Switzerland, UK", "recall_number": "Z-1844-2019", "product_description": "Zenith Alpha Abdominal Endovascular Graft, Reference Part Numbers: ZIMB-22-108, ZIMB-22-118, ZIMB-22-128, ZIMB-22-70, ZIMB-22-84, ZIMB-22-98, ZIMB-24-108, ZIMB-24-118, ZIMB-24-128, ZIMB-24-70, ZIMB-24-84, ZIMB-24-98, ZIMB-26-108, ZIMB-26-118, ZIMB-26-128, ZIMB-26-70, ZIMB-26-84, ZIMB-26-98, ZIMB-28-108, ZIMB-28-118, ZIMB-28-128, ZIMB-28-70, ZIMB-28-84, ZIMB-28-98, ZIMB-30-108, ZIMB-30-118, ZIMB-30-128, ZIMB-30-70, ZIMB-30-84, ZIMB-30-98, ZIMB-32-108, ZIMB-32-118, ZIMB-32-128, ZIMB-32-70, ZIMB-32-84, ZIMB-32-98, ZIMB-36-108, ZIMB-36-118, ZIMB-36-128, ZIMB-36-70, ZIMB-36-84, ZIMB-36-98", "product_quantity": "1027", "reason_for_recall": "may contain a damaged gray safety lock knob, which could potentially result in difficulty or an inability to fully deploy the graft via the standard or troubleshooting method provided in the Instructions for Use (IFU). Potential adverse events that may occur if an affected product is used include a prolonged procedure and open surgical intervention.", "recall_initiation_date": "20190426", "center_classification_date": "20190619", "termination_date": "20191108", "report_date": "20190626", "code_info": "9221784, 9228731, 9232249, 9246529, 9272685, 9272835, 9276029, 9276400, 9303245, 9373623, 9406776, 9466908, 9506559, 9525188, 9557569, 9566160, 9566211, 9575380, 9620378, 9620379, 9620382, 9625916, 9625917, 9636371, 9640584, 9663986 9406777, 9522416, 9566161, 9575382, 9625918, 9656992 9557570, 9566162, 9575383, 9625919, 9625920, 9656978 9221629, 9232247, 9276401, 9303246, 9373624, 9394051, 9403262, 9406778, 9406779, 9406780, 9453299, 9466909, 9466910, 9482147, 9486290, 9486313, 9506616, 9522418, 9522419, 9525189, 9529047, 9534284, 9555442, 9555453, 9555475, 9566214, 9572229, 9575386, 9592482, 9592485, 9594196, 9594205, 9609105, 9617443, 9617445, 9625921, 9625922, 9625923, 9636298, 9636330, 9640585, 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