{ "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": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "142338", "product_res_number": "Z-0698-2016", "event_date_initiated": "2015-11-20", "event_date_created": "2016-02-25", "recall_status": "Terminated", "event_date_terminated": "2018-03-06", "res_event_number": "72837", "product_code": "KFZ", "product_description": "WARM STEAM Personal Steam Inhaler-Adjustable control to regulate flow of steam Soft touch facial & nasal masks\"\nProduct labeling reads in part: \"Well at Walgreens***WARM \nHelps relieve symptoms of stuffy nasal passages, congestion or scratchy throats due to cold, flu or allergies", "code_info": "Model: PJ1011 Item: 366596 UPC code: 31191717008 Lot No. 08/14: 45228pcs Lot No. 12/14: 21096pcs Lot No. 01/15: 14220pcs Lot No. 03/15: 20040pcs", "firm_fei_number": "3008651658", "recalling_firm": "Bigwall Enterprises", "address_1": "125 55th St Ste 200 125 55th St", "address_2": "Ste 200", "city": "Clarendon Hills", "state": "IL", "postal_code": "60514-6307", "additional_info_contact": "Consumer Services\n877-365-6274", "reason_for_recall": "\"The public reason for the recall is that the product is being recalled out of an abundance of caution due to one or more consumer complaints, which have been independently investigated and remain unconfirmed. No causal connection between the complaints and the producta\"s proper use as instructed have been determined.\"", "root_cause_description": "Unknown/Undetermined by firm", "action": "The firm has only sold the product to Walgreens. Walgreens has notified all of its distribution centers and stores. According to the firm: \"Walgreens has issued a stop sale at the store level. Units removed from store shelves and in stock will be sent back to the Walgreens distribution center Valparaiso, Indiana. As units are received from all store locations they will be sent to Bigwall Enterprises.\"", "product_quantity": "87503", "distribution_pattern": "Nationwide Distribution including Washington, DC, U.S. Virgin Islands, and Puerto Rico.", "openfda": { "device_name": "Humidifier, Non-Direct Patient Interface (Home-Use)", "medical_specialty_description": "Anesthesiology", "regulation_number": "868.5460", "device_class": "1", "k_number": [ "K871189", "K830896", "K871661", "K840118", "K894734", "K862042", "K831646", "K950116", "K862171", "K851220", "K842275", "K810335", "K852283", "K790966", "K760341", "K811161", "K862919", "K915603", "K781591", "K850711" ], "registration_number": [ "3012416077", "3014153468", "1000190272", "3015191173", "3022568093", "3005587132", "3040108652", "3011187730", "3007816986", "3028172072", "3017429279", "3031369651", "3022106572", "3021235837", "3015968545", "3009197857", "9710609", "3022929665", "3014471045", "3017265430", "3017886332", "3010186069", "3008115001", "3013689783", "3003751839", "9616354", "1720839", "3029915531", "3010402691", "3013550220", "3017222105", "3015603280", "3022528821", "3016053560", "2110540", "3016195240", "3033011342", "3006563173", "3006450017", "9616843", "3008395118", "3038214786", "3008567544", "3002798681", "3010683450", "3014632466", "3037650313", "3010169226", "9710567", "3039435282", "3004139830", "3016610659", "3011547157", "1000467313", "1314417", "3006547005", "3019887520", "3004871905", "9710644", "3016734145", "3004264602", "3004152208", "3008281139", "8044099", "3008687634", "3008496560", "3009537407", "3034397208", "3015989868", "3026282195", "1220479", "8030673", "3017555752", "3010621964", "3008791328", "3045058049", "3003902679", "3010405299", "3017858989", "3006606984", "1217805", "1836161", "3012134907", "3014442295", "3016674860", "3007384659", "3004668337", "3009529084", "3006169981", "3020751316", "1530881", "8030607", "3004116032", "3033905868", "3014615028", "3013579894", "3008789244", "3011919098", "3007770329", "3014810929", "3004569415", "3007360714", "3013521677", "3004134948", "3010408344", "3017618922", "3005980667", "9616085", "3003862188", "3010341502", "3011077581", "1043899", "3012208431", "3021244152", "1422443", "3014561131", "2028807", "1419185", "1924066", "3010834934", "3016068274" ], "fei_number": [ "3012416077", "3014153468", "1000190272", "3015191173", "3022568093", "3005587132", "3040108652", "3011187730", "3007816986", "3028172072", "3017429279", "3031369651", "3022106572", "1000374126", "3021235837", "3015968545", "3009197857", "3022929665", "3014471045", "3017265430", "3010186069", "3002297841", "3008115001", "3013689783", "3003751839", "3003949221", "3029915531", "3010402691", "3013550220", "3017222105", "3015603280", "3022528821", "3016053560", "3016195240", "3033011342", "3006563173", "3002750084", "3006450017", "3008395118", "3038214786", "3007429416", "3008567544", "3002798681", "3010683450", "3006509795", "3014632466", "3003188183", "3037650313", "3010169226", "3003418980", "3039435282", "3004139830", "3016610659", "3011547157", "1000467313", "1314417", "3003202721", "3006547005", "3019887520", "3004871905", "3016734145", "3004264602", "3004152208", "3008281139", "3008687634", "3008496560", "3009537407", "3034397208", "3015989868", "3026282195", "1220479", "3017555752", "3010621964", "3008791328", "3045058049", "3003902679", "3010405299", "3017858989", "3006606984", "1217805", "3012134907", "3014442295", "3016674860", "3007384659", "3004668337", "3009529084", "3018020023", "3006169981", "1000065475", "3020751316", "3003256355", "3004116032", "3033905868", "3014615028", "3013579894", "3008789244", "3003807346", "3011919098", "3007770329", "3014810929", "3004569415", "3007360714", "3013521677", "3004134948", "3010408344", "3017618922", "3005980667", "1000143485", "3003862188", "3010341502", "3011077581", "1043899", "3012208431", "3004213967", "3021244152", "3014561131", "1419185", "1924066", "3010834934", "3016068274", "3004458261" ] } } ] }