Respironics, Inc. REMstar Heated Humidifier ( Respiratory Gas Humidifer) Model numbers 1005792, U1005792, R1005792, SC1005792, AC1005792, 1007861, R1007861, and JP1007861. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
REMstar Heated Humidifier ( Respiratory Gas Humidifer) Model numbers 1005792, U1005792, R1005792, SC1005792, AC1005792, 1007861, R1007861, and JP1007861.
Brand
Respironics, Inc.
Lot Codes / Batch Numbers
Model numbers 1005792, U1005792, R1005792, SC1005792, AC1005792, 1007861, R1007861, H000546, H00593, H000596, H000599, H000967, H001052, H001054, H001320, H001394, H001454, H001537, H001555, H001589, H001614, H001631, H001964, H002120, H002421, H002491, H002582, H002794, H002817, H002822, H002978, H003083, H003590, H003665, H003739, H004117, H004747, H004804, H004971, H004978, H005289, H005405, H005411, H005416, H005534, H005550, H005577, H005681, H005876, H006214, H006448, H006665, H006700, H006711, H006819, H007080, H007104, H007683, H007828, H007907, H008213, H008295, H008348, H008452, H008549, H008588, H008733, H008956, H009282, H009670, H009797, H009838, H009858, H009894, H010883, H011283, H011636, H012040, H012080, H012120, H012288, H012621, H012737, H012819, H013327, H013346, H013727, H014040, H014432, H014449, H014541, H014565, H014752, H014753, H014898, H015446, H015760, H015761, H015848, H015859, H015873, H016071, H016112, H016276, H016552, H016629, H016665, H016753, H016895, H016913, H016926, H017170, H017195, H017270, H017294, H017382, H017483, H017905, H018031, H018037, H018435, H018717, H018735, H018963, H018965, H018995, H019041, H019069, H019088, H019348, H019362, H019371, H019385, H019586, H019685, H019786, H019807, H019837, H019839, H019867, H019923, H019985, H020053, H020253, H020502, H020518, H020538, H020562, H020572, H020583, H020597, H020606, H020647, H020713, H020727, H020739, H020754, H020889, H021619, H021781, H021838, H021943, H022085, H022283, H022286, H022297, H022366, H022369, H022412, H022512, H022514, H023004, H023159, H023331, H023583, H023602, H023720, H023745, H023791, H023797, H023821, H023912, H024779, H025127, H025226, H025304, H025317, H025321, H025398, H025434, H025560, H025969, H026008, H026132, H026156, H026158, H026199, H026202, H026206, H026207, H026364, H026405, H026425, H026726, H026759, H027046, H027122, H027239, H027478, H027507, H027694, H027765, H027904, H027986, H028025, H028080, H028282, H028408, H028549, H028594, H029078, H029429, H029529, H029538, H029564, H029808, H029875, H029923, H030136, H030151, H030244, H030407, H030491, H030672, H030937, H031059, H031064, H031089, H031119, H031220, H031245, H031255, H031270, H031300, H031370, H031386, H031434, H031484, H031486, H031602, H031766, H031857, H031893, H032112, H032130, H032289, H032298, H032418, H032672, H032762, H032788, H032794, H032806, H032923, H033048, H033134, H033171, H033286, H033305, H033400, H034422, H034493, H034624, H034687, H034704, H035098, H035138, H035270, H035295, H035801, H035954, H036042, H036268, H036440, H036655, H036878, H037043, H037203, H037235, H037343, H037433, H037585, H037592, H037897, H038061, H038147, H038170, H038254, H038500, H038507, H038657, H038720, H038789, H038915, H038921, H039024, H039084, H039157, H039231, H039420, H039431, H039542, H039922, H040025, H040133, H040300, H040349, H040403, H040462, H040480, H040493, H040590, H040912, H041200, H041254, H041298, H041322, H041346, H041595, H041879, H041884, H041886, H041892, H041896, H042261, H042419, H042420, H042527, H042912, H042992, H042997, H043012, H043461, H043494, H043692, H043763, H043877, H043973, H043991, H044274, H044317, H044338, H044128, H044185, H044414, H044468, H044480, H044544, H044565, H044759, H044849, H044878, H044909, H044954, H045276, H045381, H045406, H045466, H045486, H045494, H045498, and HO45514.
Products Sold
Model numbers 1005792, U1005792, R1005792, SC1005792, AC1005792, 1007861, R1007861, and JP1007861. Serial numbers range affected H045582 through H239662. Individual serial numbers are: H000524, H000546, H00593, H000596, H000599, H000967, H001052, H001054, H001320, H001394, H001454, H001537, H001555, H001589, H001614, H001631, H001964, H002120, H002421, H002491, H002582, H002794, H002817, H002822, H002978, H003083, H003590, H003665, H003739, H004117, H004747, H004804, H004971, H004978, H005289, H005405, H005411, H005416, H005534, H005550, H005577, H005681, H005876, H006214, H006448, H006665, H006700, H006711, H006819, H007080, H007104, H007683, H007828, H007907, H008213, H008295, H008348, H008452, H008549, H008588, H008733, H008956, H009282, H009670, H009797, H009838, H009858, H009894, H010883, H011283, H011636, H012040, H012080, H012120, H012288, H012621, H012737, H012819, H013327, H013346, H013727, H014040, H014432, H014449, H014541, H014565, H014752, H014753, H014898, H015446, H015760, H015761, H015848, H015859, H015873, H016071, H016112, H016276, H016552, H016629, H016665, H016753, H016895, H016913, H016926, H017170, H017195, H017270, H017294, H017382, H017483, H017905, H018031, H018037, H018435, H018717, H018735, H018963, H018965, H018995, H019041, H019069, H019088, H019348, H019362, H019371, H019385, H019586, H019685, H019786, H019807, H019837, H019839, H019867, H019923, H019985, H020053, H020253, H020502, H020518, H020538, H020562, H020572, H020583, H020597, H020606, H020647, H020713, H020727, H020739, H020754, H020889, H021619, H021781, H021838, H021943, H022085, H022283, H022286, H022297, H022366, H022369, H022412, H022512, H022514, H023004, H023159, H023331, H023583, H023602, H023720, H023745, H023791, H023797, H023821, H023912, H024779, H025127, H025226, H025304, H025317, H025321, H025398, H025434, H025560, H025969, H026008, H026132, H026156, H026158, H026199, H026202, H026206, H026207, H026364, H026405, H026425, H026726, H026759, H027046, H027122, H027239, H027478, H027507, H027694, H027765, H027904, H027986, H028025, H028080, H028282, H028408, H028549, H028594, H029078, H029429, H029529, H029538, H029564, H029808, H029875, H029923, H030136, H030151, H030244, H030407, H030491, H030672, H030937, H031059, H031064, H031089, H031119, H031220, H031245, H031255, H031270, H031300, H031370, H031386, H031434, H031484, H031486, H031602, H031766, H031857, H031893, H032112, H032130, H032289, H032298, H032418, H032672, H032762, H032788, H032794, H032806, H032923, H033048, H033134, H033171, H033286, H033305, H033400, H034422, H034493, H034624, H034687, H034704, H035098, H035138, H035270, H035295, H035801, H035954, H036042, H036268, H036440, H036655, H036878, H037043, H037203, H037235, H037343, H037433, H037585, H037592, H037897, H038061, H038147, H038170, H038254, H038500, H038507, H038657, H038720, H038789, H038915, H038921, H039024, H039084, H039157, H039231, H039420, H039431, H039542, H039922, H040025, H040133, H040300, H040349, H040403, H040462, H040480, H040493, H040590, H040912, H041200, H041254, H041298, H041322, H041346, H041595, H041879, H041884, H041886, H041892, H041896, H042261, H042419, H042420, H042527, H042912, H042992, H042997, H043012, H043461, H043494, H043692, H043763, H043877, H043973, H043991, H044274, H044317, H044338, H044128, H044185, H044414, H044468, H044480, H044544, H044565, H044759, H044849, H044878, H044909, H044954, H045276, H045381, H045406, H045466, H045486, H045494, H045498, and HO45514.
Respironics, Inc. is recalling REMstar Heated Humidifier ( Respiratory Gas Humidifer) Model numbers 1005792, U1005792, R1005792, S due to AC inlet connector failure that can result in thermal damage to the humidifier enclosure and/or ignition of materials external to the device. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
AC inlet connector failure that can result in thermal damage to the humidifier enclosure and/or ignition of materials external to the device
Recommended Action
Per FDA guidance
The recalling firm issued a recall letter dated 10/25/06 to their domestic and Canadian dealers informing them of the problem and the need to contact the end users. These dealers were given two options: 1) contact the end user by forwarding a letter the recalling firm provided or 2) contacting the third party company with their distribution list. The recalling firm issued a recall letter dated 10/25/06 regarding the service repair kit and the need to contact end users that had the device repaired using this kit. The recalling firm issued a recall letter date 10/25/06 to the international customers informing them of the problem, contact the end users, and the need to destroy the recalled part.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026