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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Critical RiskFDA Device

Philips Respironics, Inc.: No contraindication/warning regarding magnetic components in CPAP masks for patients with implantable devices or metallic splinters in the eyes.

Agency Publication Date: September 30, 2022
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Affected Products

Product: Philips Respironics Amara View Minimal Contact Full-Face Mask

All Units; Model No: 1090602, 1090603, 1090604, 1090622, 1090623, 1090624, 1090641, 1090642, 1090643, 1090644, 1090651, 1090652, 1090653, 1090654, 1090662, 1090663, 1090664, 1090670, 1090696, 1090697, 1135080, 1135081, 1135082, 1136626, 1090670RTL, 1136626RTL.

Product: Philips Respironics DreamWear Full Face Mask

All Units; Model No.: 1133344, 1133345, 1133370, 1133371, 1133372, 1133373, 1133375, 1133376, 1133377, 1133378, 1133380, 1133381, 1133382, 1133383, 1133385, 1133386, 1133387, 1133388, 1133390, 1133391, 1133392, 1133393, 1133395, 1133400, 1133401, 1133405, 1133406, 1133407, 1133408, 1133410, 1133411, 1133412, 1133413, 1133415, 1133416, 1133417, 1133418, 1133423, 1133424, 1133425, 1133427, 1133430, 1133431, 1133432, 1133433, 1133434, 1133435, 1133436, 1133438, 1133450, 1133454, 1135275, 1135276, 1135277, 1135278, 1135327, 1135388, 1135389, 1135390, 1137430, 1137431, 1137437, 1137438, 1137439, 1137440, 1140235, 1143130, 1144347, 1146593, 1146594, 1146595, 1146596, 1146597, 1148363, 1133375RTL, 1133376RTL, 1133377RTL, 1133378RTL, 1133430RTL, 1133431RTL, 1133432RTL, 1133433RTL.

Product: DreamWisp Nasal Mask with Over the Nose Cushion

All Units; Model No.: 1137916, 1137918, 1137921, 1137922, 1137923, 1137924, 1137925, 1137926, 1137927, 1137928, 1137929, 1137930, 1137931, 1137932, 1137933, 1137934, 1137935, 1137936, 1137937, 1137938, 1137939, 1137940, 1137941, 1137942, 1137943, 1137944, 1137945, 1137946, 1137947, 1137948, 1137949, 1137950, 1137951, 1137953, 1137954, 1137955, 1137964, 1137965, 1137966, 1139332, 1139333, 1139334, 1139335, 1139336, 1144344, 1144345, 1144346, 1144502, 1148409, 1148410, 1148411, 1148913, 1148914, 1148915, 1148916, 1148917, 1137916RTL, 1137942AP, 1137942CE, 1137942RC, 1137943AP, 1137943CE, 1137943RC, 1137944AP, 1137944CE, 1137944RC, 1137945AP, 1137945CE, 1137945RC, 1137946AP, 1137946CE, 1137946RC.

Product: Wisp and Wisp Youth Nasal Mask

All Units; Model No.: 1094050, 1094051, 1094053, 1094060, 1094061, 1094062, 1094070, 1094071, 1094072, 1094073, 1109298, 1113954, 1117119, 1118060, 1118061, 1118062, 1118063, 1118064, 1118065, 1118066, 1118067, 1120434, 1137360, 1137361, 1137366, 1137367, 1137368, 1137369, 1137370, 1138989, 1138991, 1138992, 1138993, 1138994, 1138995, 1138996, 1139009, 1148366, 1094051RTL.

Product: Therapy Mask 3100 NC/SP

All Units; Model No.: 1144608, 1144610, 1145038, 1145039, 1145040, 1145041, 1145044, 1145045, 1145046, 1145047, 1145048, 1145049, 1145050, 1145051, 1145052, 1145055, 1145056, 1145057, 1145058, 1145059, 1145060, 1145061, 1145062, 1145063, 1145064, 1145065, 1145066, 1145067, 1145068, 1145069, 1145070, 1145071, 1145072, 1145073, 1145074, 1145459, 1145460, 1145461, 1145462, 1145463, 1145464, 1145465, 1145466, 1145467, 1145478, 1145916, 1145917.

Product Images

Impacted Masks

Impacted Masks

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 90705
Status: Active
Manufacturer: Philips Respironics, Inc.
Manufactured In: United States
Units Affected: 5 products (5,661,639 units; 9,191,280 units; 930,813 units; 6,237,558 units; 42,954 units)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · FDA Press Release · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. 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. Refer to the openFDA terms of service for more information.