{ "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": "2026-08-13", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "160806", "product_res_number": "Z-0419-2018", "event_date_initiated": "2017-07-21", "event_date_created": "2018-01-27", "recall_status": "Terminated", "event_date_terminated": "2018-03-22", "res_event_number": "78886", "product_code": "DWJ", "k_numbers": [ "K101705" ], "product_description": "MA3320-PM Premium Adult - SYK Mistral-Air Premium Blankets. MODEL #: MA3302-PM. CATALOG #(s): MA3302-PM", "code_info": "LOT #(s):  1640002, 1645003", "firm_fei_number": "1831750", "recalling_firm": "Stryker Medical Division of Stryker Corporation", "address_1": "3800 E Centre Ave", "city": "Portage", "state": "MI", "postal_code": "49002-5826", "reason_for_recall": "It was identified that the Mistral-Air Premium blankets may be capable of\nconducting electricity during a defibrillation or cardioversion therapy at higher\nenergy levels (70 Joules or more) when the blanket is applied with the reflective\nside toward the patient (upside down).", "root_cause_description": "Component design/selection", "action": "Stryker notified customers of the recall by sending Customer Notification and Business Reply Forms, dated July 21, 2017.", "product_quantity": "11160", "distribution_pattern": "U.S.", "openfda": { "k_number": [ "K072513", "K231211", "K920432", "K040911", "K232844", "K140078", "K910327", "K914382", "K062794", "K040440", "K242964", "K761087", "K180834", 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