{ "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": "141042", "product_res_number": "Z-0272-2016", "event_date_initiated": "2015-10-08", "event_date_posted": "2015-11-13", "recall_status": "Terminated", "event_date_terminated": "2016-10-27", "res_event_number": "72449", "product_code": "CAN", "k_numbers": [ "K901831" ], "product_description": "Easy Dial Oxygen Regulator, 168708D and 168715D.\r\n\r\nEight liter from .0.25 to 8 liters, 15 liter from 0.5 liter to 15 liters of oxygen per minute.", "code_info": "Lot numbers 072215 and 072315.", "firm_fei_number": "2523148", "recalling_firm": "Precision Medical, Inc.", "address_1": "300 Held Dr", "city": "Northampton", "state": "PA", "postal_code": "18067-1150", "additional_info_contact": "610-262-6090", "reason_for_recall": "These lots of Oxygen Dial Regulators could have the settings label off by one position. When the indicator arrow points to OFF position, the regulator is actually on the half liter setting (0.50), for the 15 liter. For the 8 liter, instead of being in the OFF position, the regulator will be in the quarter liter setting (0.25).", "root_cause_description": "Error in labeling", "action": "The firm sent \"Attention Field Corrective Action\" letters, dated Oct 8, 2015, to customers. The letter identified the affected device and explained the reason for the recall. The letter provided instructions on how to check the regulator; and asked customers to call the number provided for a replacement if a regulator is labeled incorrectly.", "product_quantity": "315", "distribution_pattern": "Distributed in the US to the states of PA, MA, MO, MT, ID, MI, MN, ND, KY, NY, NC, CA, AL, AZ, LA, OH, TX, GA, IN, and OK.", "openfda": { "k_number": [ "K852649", "K771241", "K894302", "K900115", "K844622", "K883483", "K893621", "K872170", "K932006", "K896152", "K802644", "K852663", "K830844", "K912174", "K914271", "K891771", "K915154", "K810679", "K894850", "K813466", "K884927", "K850106", "K772216", "K162811", "K896128", "K834061", "K915505", "K780359", "K863711", "K841367", "K811430", "K853039", "K895956", "K810132", "K901831", "K813467", "K843585", "K865077", "K803207", "K852333", "K061785", "K921125", "K852374", "K862796", "K780750", "K780364", "K950777", "K780084", "K080243", "K901623", "K060265", "K936187", "K861166", "K862193", "K942751" ], "registration_number": [ "", "1000604079", "3037012186", "3021841055", "3012311599", "3006395447", "3008281139", "1526863", "3013345545", "1832475", "9681383", "3008774304", "2085336", "8020785", "2523148", "3004111085", "2518435", "3034694958", "1121335", "1000448358", "3008115001", "3017406698", "3013524663", "3020188747", "3012971441", "2085602", "3008264111", "3004859326", "9614084", "9681409", "3010834934", "3004112621", "3011237770", "3003674698", "3013557686", "3005347827", "3020460367", "3010387558", "1000153536", "3009327812", "3043127556", "2025816", "3004034546", "1000359047", "1417592", "1044295", "1836161", "9611451", "3006783791", "3012316249", "3003418325", "1610287", "3023809973", "3007222468", "1526809", "3005448067", "1924066", "3014810929", "1937613", "3033959233", "3006534178", "1416980", "3010373263", "3012777736", "9613416", "3005380088", "3006563173", "9616354", "3020751316", "2020813", "3006446479", "2020601", "1062191", "3009512503", "1017294", "3007360714", "3002637618", "2432235", "3006157842", "2183425", "3013744387", "2225311", "9611500", "1419185", "3008307149", "3008808097", "3022528821", "3007019343", "2937398", "3021244152", "3003207908", "2030745", "8010130", "3005206084", "3013156250", "9610861", "3014273557", "3020410611", "3017181414", "1530881", "3008812560", "9615102", "3029706818", "3008791328", "2183615", "3023339109", "3030128613", "3009291251", "9710567", "3043047771", "9610105", "3016426850", "3010394125", "3004145585" ], "fei_number": [ "", "1000604079", "3037012186", "3021841055", "3012311599", "3001655525", "3006395447", "3008281139", "1526863", "3013345545", "1832475", "3008774304", "2523148", "3004111085", "2518435", "3034694958", "1121335", "1000448358", "3008115001", "3017406698", "3013524663", "3020188747", "3012971441", "3008264111", "3004859326", "3002807836", "3003418980", "3010834934", "3004112621", "3011237770", "3003674698", "3005468265", "3013557686", "3001620388", "3005347827", "3002806783", "3010387558", "3020460367", "1000271197", "1000153536", "3009327812", "3043127556", "2025816", "3004034546", "1000359047", "1417592", "1044295", "3000210616", "3012316249", "3006783791", "3003418325", "1610287", "3023809973", "3002750084", "3007222468", "1526809", "3005448067", "1924066", "3014810929", "3002297841", "1937613", "3001104093", "3033959233", "1000509422", "3006534178", "1416980", "3010373263", "3003256355", "3012777736", "3005380088", "1000614294", "3006563173", "3020751316", "3000719543", "2020813", "3006446479", "2020601", "3009512503", "1017294", "3007360714", "3002637618", "2432235", "3006157842", "3002806988", "2183425", "3013744387", "2225311", "1419185", "3008307149", "3008808097", "3022528821", "3007019343", "2937398", "3021244152", "3003207908", "3005206084", "3013156250", "3014273557", "3020410611", "1000306460", "3017181414", "3008812560", "3029706818", "3008791328", "2183615", "3023339109", "3030128613", "3009291251", "3000204983", "3043047771", "3016426850", "3010394125", "3004145585" ], "device_name": "Regulator, Pressure, Gas Cylinder", "medical_specialty_description": "Anesthesiology", "regulation_number": "868.2700", "device_class": "1" } } ] }