{ "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": "Portage", "state": "MI", "country": "United States", "classification": "Class II", "openfda": {}, "product_type": "Devices", "event_id": "65337", "recalling_firm": "Stryker Medical Division of Stryker Corporation", "address_1": "3800 E Centre Ave", "address_2": "", "postal_code": "49002-5826", "voluntary_mandated": "Voluntary: Firm initiated", "initial_firm_notification": "Letter", "distribution_pattern": "Nationwide Distribution-USA including the states of OH, ME, IL, CO , FL, TX, MI, GA, and VA.", "recall_number": "Z-1946-2013", "product_description": "IsoGel AIR 84, Support Surface. Intended to assist in improving human patient outcomes.", "product_quantity": "586 units", "reason_for_recall": "Complaints were received from the field indicating that some Air Pumps were flashing and alarming when connected to the IsoGel AIR\" surface upon turning the pump on and the setting it to the \u001cIsoGel AIR\u001d Mode. Upon further investigation, it was determined that the flashing/alarm being experienced was due to the air pressure being out of the expected range; indicating a blockage within the LAL tubi", "recall_initiation_date": "20130712", "center_classification_date": "20130809", "termination_date": "20140911", "report_date": "20130821", "code_info": "Model Numbers: 2860-000-001 and 2860-000-002 and serial numbers: 121228600100355, 121228600100356, 121228600100357, 121228600200315, 121228600200316 121228600200322, 121228600200323, 121228600200324, 121228600200325, 121228600200326 121228600200332, 121228600200333, 121228600200334, 121228600200335, 121228600200336 121228600200342, 121228600200343, 121228600200344, 121228600200345, 121228600200346 121228600200352, 121228600200353, 121228600200367, 121228600200368, 121228600200369 121228600200375, 121228600200376, 121228600200377, 121228600200378, 121228600200379 121228600200386, 121228600200393, 121228600200394, 121228600200395, 121228600200396 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