Advanced Sterilization Products Sterrad 50 Sterilizer, Product Code 10050. Low-temperature general-purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices. Recall
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According to the U.S. Food and Drug Administration (FDA)
Product
Sterrad 50 Sterilizer, Product Code 10050. Low-temperature general-purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.
Brand
Advanced Sterilization Products
Lot Codes / Batch Numbers
Affected units in the US: 10050000502, 10050000505, 10050000509, 10050000510 10050000513, 10050000516, 10050000517, 10050000532, 10050000534, 10050000545, 10050000548, 10050000549, 10050000551, 10050000552, 10050000554, 10050000564, 10050000567, 10050000570, 10050000574, 10050000576, 10050000588, 10050000597, 10050000606, 10050000609, 10050000613, 10050000614, 10050000615, 10050000616, 10050000617, 10050000618, 10050000621, 10050000624, 10050000625, 10050000627, 10050000635, 10050000644, 10050000648, 10050000653, 10050000662, 10050000673, 10050000676, 10050000680, 10050000686, 10050000692, 10050000694, 10050000705, 10050000710, 10050000712, 10050000713, 10050000714, 10050000717, 10050000725, 10050000727, 10050000728, 10050000729, 10050000730, 10050000739, 10050000745, 10050000756, 10050000759, 10050000760, 10050000762, 10050000767, 10050000768, 10050000773, 10050000774, 10050000779, 10050000782, 10050000784, 10050000800, 10050000801, 10050000803, 10050000804, 10050000806, 10050000813, 10050000815, 10050000822, 10050000832, 10050000834, 10050000835, 10050000837, 10050000840, 10050000844, 10050000849, 10050000850, 10050000852, 10050000855, 10050000857, 10050000858, 10050000863, 10050000864, 10050000866, 10050000867, 10050000868, 10050000869, 10050000872, 10050000873, 10050000874, 10050000877, 10050000895, 10050000897, 10050010911, 10050010916, 10050010918, 10050010922, 10050010941, 10050010945, 10050010948, 10050010952, 10050021012, 10050021013, 10050021016, 10050021022, 10050021029, 10050021030, 10050021031, 10050021032, 10050021033, 10050021034, 10050021036, 10050021037, 10050021038, 10050021041, 10050021042, 10050021043, 10050021045, 10050021046, 10050021049, 10050021050, 10050021054, 10050021059, 10050021060, 10050021064, 10050021069, 10050021087, 10050021092, 10050021094, 10050021095, 10050021097, 10050021099, 10050021100, 10050021103, 10050021104, 10050021106, 10050021110, 10050021111, 10050021112, 10050021116, 10050021136, 10050021137, 10050021139, 10050021140, 10050021142, 10050021145, 10050021146, 10050021147, 10050021148, 10050021149, 10050021150, 10050035004, 10050035006, 10050035008, 10050035011, 10050035013, 10050035014, 10050035015, 10050035022, 10050035023, 10050035027, 10050035028, 10050035030, 10050035034, 10050035035, 10050035036, 10050035037, 10050035039, 10050035041, 10050035042, 10050035044, 10050035046, 10050035050, 10050035051, 10050035054, 10050035055, 10050035059, 10050035060, 10050035061, 10050035063, 10050035065, 10050035066, 10050035067, 10050035070, 10050035071, 10050035074, 10050035075, 10050035076, 10050035077, 10050035078, 10050035086, 10050035094, 10050035100, 10050035101, 10050035103, 10050035104, 10050035105, 10050035106, 10050035111, 10050035116, 10050035117, 10050035118, 10050035119, 10050035121, 10050035124, 10050035126, 10050035127, 10050035128, 10050035129, 10050035130, 10050035131, 10050035132, 10050035134, 10050035135, 10050035136, 10050035137, 10050035139, 10050035140, 10050035141, 10050035142, 10050035143, 10050035144, 10050035148, 10050035149, 10050035153, 10050035154, 10050035155, 10050035156, 10050035157, 10050035158, 10050035160, 10050035162, 10050035164, 10050035166, 10050035167, 10050035170, 10050035171, 10050035172, 10050035173, 10050035174, 10050035175, 10050035179, 10050035181, 10050035182, 10050035184, 10050035185, 10050035188, 10050035196, 10050035204, 10050035205, 10050035321, 10050035323, 10050035324, 10050035385, 10050970298, 10050970344, 10050980382, 10050980383, 10050980478, 10050980356, 10050980408, 10050980434, 10050980450, 10050980452, 10050980464, 10050970312 and 10050000500 and Affected units distributed internationally : 10050021141, 10050035146, 10050960065, 10050970149, 10050970201, 10050970253, 10050980089, 10050021143, 10050035161, 10050960066, 10050970150, 10050970202, 10050970254, 10050980345, 10050021144, 10050035163, 10050960067, 10050970151, 10050970203, 10050970255, 10050980346, 10050027061, 10050035165, 10050960068, 10050970152, 10050970204, 10050970256, 10050980347, 10050035001, 10050035168, 10050960069, 10050970153, 10050970205, 10050970257, 10050980348, 10050035003, 10050035176, 10050960070, 10050970154, 10050970206, 10050970258, 10050980351, 10050035005, 10050035177, 10050960071, 10050970155, 10050970207, 10050970259, 10050980353, 10050035007, 10050035178, 10050960072, 10050970156, 10050970208, 10050970260, 10050980354, 10050035009, 10050035180, 10050960073, 10050970157, 10050970209, 10050970261, 10050980357, 10050035010, 10050035183, 10050960075, 10050970158, 10050970210, 10050970262, 10050980358, 10050035016, 10050035186, 10050960076, 10050970159, 10050970211, 10050970263, 10050980363, 10050035017, 10050035187, 10050960078, 10050970160, 10050970212, 10050970264, 10050980381, 10050035018, 10050035189, 10050960080, 10050970161, 10050970213, 10050970265, 10050980384, 10050035019, 10050035190, 10050960083, 10050970162, 10050970214, 10050970269, 10050980385, 10050035020, 10050035191, 10050960086, 10050970163, 10050970215, 10050970270, 10050980391, 10050035021, 10050035192, 10050960087, 10050970164, 10050970216, 10050970271, 10050980393, 10050035024, 10050035193, 10050960088, 10050970165, 10050970217, 10050970272, 10050980396, 10050035026, 10050035194, 10050960092, 10050970166, 10050970218, 10050970273, 10050980398, 10050035031, 10050035195, 10050960096, 10050970167, 10050970219, 10050970276, 10050980399, 10050035038, 10050035197, 10050960098, 10050970168, 10050970220, 10050970277, 10050980400, 10050035040, 10050035198, 10050960099, 10050970169, 10050970221, 10050970278, 10050980402, 10050035043, 10050035199, 10050960101, 10050970170, 10050970222, 10050970279, 10050980403, 10050035045, 10050035200, 10050960103, 10050970171, 10050970223, 10050970280, 10050980405, 10050035047, 10050035202, 10050960104, 10050970172, 10050970224, 10050970283, 10050980413, 10050035048, 10050035203, 10050960105, 10050970173, 10050970225, 10050970287, 10050980414, 10050035052, 10050035206, 10050960106, 10050970174, 10050970226, 10050970288, 10050980415, 10050035056, 10050035349, 10050960111, 10050970176, 10050970227, 10050970289, 10050980417, 10050035057, 10050035357, 10050960117, 10050970177, 10050970228, 10050970290, 10050980424, 10050035058, 10050038295, 10050960118, 10050970178, 10050970229, 10050970292, 10050980425, 10050035072, 10050096063, 10050960119, 10050970179, 10050970230, 10050970293, 10050980426, 10050035073, 10050098041, 10050960314, 10050970180, 10050970232, 10050970300, 10050980427, 10050035080, 10050960028, 10050960322, 10050970181, 10050970233, 10050970301, 10050980436, 10050035081, 10050960030, 10050970120, 10050970182, 10050970234, 10050970302, 10050980437, 10050035082, 10050960036, 10050970121, 10050970183, 10050970235, 10050970306, 10050980438, 10050035083, 10050960041, 10050970123, 10050970184, 10050970236, 10050970311, 10050980439, 10050035085, 10050960046, 10050970124, 10050970185, 10050970237, 10050970313, 10050980441, 10050035088, 10050960050, 10050970128, 10050970186, 10050970238, 10050970321, 10050980442, 10050035090, 10050960051, 10050970130, 10050970187, 10050970239, 10050970323, 10050980443, 10050035095, 10050960052, 10050970131, 10050970188, 10050970240, 10050970324, 10050980444, 10050035096, 10050960053, 10050970134, 10050970189, 10050970241, 10050970325, 10050980446, 10050035097, 10050960054, 10050970136, 10050970190, 10050970242, 10050970326, 10050980447, 10050035098, 10050960055, 10050970138, 10050970191, 10050970243, 10050970327, 10050980448, 10050035099, 10050960056, 10050970140, 10050970192, 10050970244, 10050970329, 10050980449, 10050035102, 10050960057, 10050970141, 10050970193, 10050970245, 10050970329, 10050980453, 10050035108, 10050960058, 10050970142, 10050970194, 10050970246, 10050970330, 10050980461, 10050035112, 10050960059, 10050970143, 10050970195, 10050970247, 10050970331, 10050980462, 10050035113, 10050960060, 10050970144, 10050970196, 10050970248, 10050970332, 10050980469, 10050035114, 10050960061, 10050970145, 10050970197, 10050970249, 10050970333, 10050980470, 10050035122, 10050960062, 10050970146, 10050970198, 10050970250, 10050970338, 10050980471, 10050035125, 10050960063, 10050970147, 10050970199, 10050970251, 10050970339, 10050980475, 10050035145, 10050960064, 10050970148, 10050970200, 10050970252, 10050970340 and 10050980480.
Products Sold
Affected units in the US: 10050000502, 10050000505, 10050000509, 10050000510 10050000513, 10050000516, 10050000517, 10050000532, 10050000534, 10050000545, 10050000548, 10050000549, 10050000551, 10050000552, 10050000554, 10050000564, 10050000567, 10050000570, 10050000574, 10050000576, 10050000588, 10050000597, 10050000606, 10050000609, 10050000613, 10050000614, 10050000615, 10050000616, 10050000617, 10050000618, 10050000621, 10050000624, 10050000625, 10050000627, 10050000635, 10050000644, 10050000648, 10050000653, 10050000662, 10050000673, 10050000676, 10050000680, 10050000686, 10050000692, 10050000694, 10050000705, 10050000710, 10050000712, 10050000713, 10050000714, 10050000717, 10050000725, 10050000727, 10050000728, 10050000729, 10050000730, 10050000739, 10050000745, 10050000756, 10050000759, 10050000760, 10050000762, 10050000767, 10050000768, 10050000773, 10050000774, 10050000779, 10050000782, 10050000784, 10050000800, 10050000801, 10050000803, 10050000804, 10050000806, 10050000813, 10050000815, 10050000822, 10050000832, 10050000834, 10050000835, 10050000837, 10050000840, 10050000844, 10050000849, 10050000850, 10050000852, 10050000855, 10050000857, 10050000858, 10050000863, 10050000864, 10050000866, 10050000867, 10050000868, 10050000869, 10050000872, 10050000873, 10050000874, 10050000877, 10050000895, 10050000897, 10050010911, 10050010916, 10050010918, 10050010922, 10050010941, 10050010945, 10050010948, 10050010952, 10050021012, 10050021013, 10050021016, 10050021022, 10050021029, 10050021030, 10050021031, 10050021032, 10050021033, 10050021034, 10050021036, 10050021037, 10050021038, 10050021041, 10050021042, 10050021043, 10050021045, 10050021046, 10050021049, 10050021050, 10050021054, 10050021059, 10050021060, 10050021064, 10050021069, 10050021087, 10050021092, 10050021094, 10050021095, 10050021097, 10050021099, 10050021100, 10050021103, 10050021104, 10050021106, 10050021110, 10050021111, 10050021112, 10050021116, 10050021136, 10050021137, 10050021139, 10050021140, 10050021142, 10050021145, 10050021146, 10050021147, 10050021148, 10050021149, 10050021150, 10050035004, 10050035006, 10050035008, 10050035011, 10050035013, 10050035014, 10050035015, 10050035022, 10050035023, 10050035027, 10050035028, 10050035030, 10050035034, 10050035035, 10050035036, 10050035037, 10050035039, 10050035041, 10050035042, 10050035044, 10050035046, 10050035050, 10050035051, 10050035054, 10050035055, 10050035059, 10050035060, 10050035061, 10050035063, 10050035065, 10050035066, 10050035067, 10050035070, 10050035071, 10050035074, 10050035075, 10050035076, 10050035077, 10050035078, 10050035086, 10050035094, 10050035100, 10050035101, 10050035103, 10050035104, 10050035105, 10050035106, 10050035111, 10050035116, 10050035117, 10050035118, 10050035119, 10050035121, 10050035124, 10050035126, 10050035127, 10050035128, 10050035129, 10050035130, 10050035131, 10050035132, 10050035134, 10050035135, 10050035136, 10050035137, 10050035139, 10050035140, 10050035141, 10050035142, 10050035143, 10050035144, 10050035148, 10050035149, 10050035153, 10050035154, 10050035155, 10050035156, 10050035157, 10050035158, 10050035160, 10050035162, 10050035164, 10050035166, 10050035167, 10050035170, 10050035171, 10050035172, 10050035173, 10050035174, 10050035175, 10050035179, 10050035181, 10050035182, 10050035184, 10050035185, 10050035188, 10050035196, 10050035204, 10050035205, 10050035321, 10050035323, 10050035324, 10050035385, 10050970298, 10050970344, 10050980382, 10050980383, 10050980478, 10050980356, 10050980408, 10050980434, 10050980450, 10050980452, 10050980464, 10050970312 and 10050000500 and Affected units distributed internationally : 10050021141, 10050035146, 10050960065, 10050970149, 10050970201, 10050970253, 10050980089, 10050021143, 10050035161, 10050960066, 10050970150, 10050970202, 10050970254, 10050980345, 10050021144, 10050035163, 10050960067, 10050970151, 10050970203, 10050970255, 10050980346, 10050027061, 10050035165, 10050960068, 10050970152, 10050970204, 10050970256, 10050980347, 10050035001, 10050035168, 10050960069, 10050970153, 10050970205, 10050970257, 10050980348, 10050035003, 10050035176, 10050960070, 10050970154, 10050970206, 10050970258, 10050980351, 10050035005, 10050035177, 10050960071, 10050970155, 10050970207, 10050970259, 10050980353, 10050035007, 10050035178, 10050960072, 10050970156, 10050970208, 10050970260, 10050980354, 10050035009, 10050035180, 10050960073, 10050970157, 10050970209, 10050970261, 10050980357, 10050035010, 10050035183, 10050960075, 10050970158, 10050970210, 10050970262, 10050980358, 10050035016, 10050035186, 10050960076, 10050970159, 10050970211, 10050970263, 10050980363, 10050035017, 10050035187, 10050960078, 10050970160, 10050970212, 10050970264, 10050980381, 10050035018, 10050035189, 10050960080, 10050970161, 10050970213, 10050970265, 10050980384, 10050035019, 10050035190, 10050960083, 10050970162, 10050970214, 10050970269, 10050980385, 10050035020, 10050035191, 10050960086, 10050970163, 10050970215, 10050970270, 10050980391, 10050035021, 10050035192, 10050960087, 10050970164, 10050970216, 10050970271, 10050980393, 10050035024, 10050035193, 10050960088, 10050970165, 10050970217, 10050970272, 10050980396, 10050035026, 10050035194, 10050960092, 10050970166, 10050970218, 10050970273, 10050980398, 10050035031, 10050035195, 10050960096, 10050970167, 10050970219, 10050970276, 10050980399, 10050035038, 10050035197, 10050960098, 10050970168, 10050970220, 10050970277, 10050980400, 10050035040, 10050035198, 10050960099, 10050970169, 10050970221, 10050970278, 10050980402, 10050035043, 10050035199, 10050960101, 10050970170, 10050970222, 10050970279, 10050980403, 10050035045, 10050035200, 10050960103, 10050970171, 10050970223, 10050970280, 10050980405, 10050035047, 10050035202, 10050960104, 10050970172, 10050970224, 10050970283, 10050980413, 10050035048, 10050035203, 10050960105, 10050970173, 10050970225, 10050970287, 10050980414, 10050035052, 10050035206, 10050960106, 10050970174, 10050970226, 10050970288, 10050980415, 10050035056, 10050035349, 10050960111, 10050970176, 10050970227, 10050970289, 10050980417, 10050035057, 10050035357, 10050960117, 10050970177, 10050970228, 10050970290, 10050980424, 10050035058, 10050038295, 10050960118, 10050970178, 10050970229, 10050970292, 10050980425, 10050035072, 10050096063, 10050960119, 10050970179, 10050970230, 10050970293, 10050980426, 10050035073, 10050098041, 10050960314, 10050970180, 10050970232, 10050970300, 10050980427, 10050035080, 10050960028, 10050960322, 10050970181, 10050970233, 10050970301, 10050980436, 10050035081, 10050960030, 10050970120, 10050970182, 10050970234, 10050970302, 10050980437, 10050035082, 10050960036, 10050970121, 10050970183, 10050970235, 10050970306, 10050980438, 10050035083, 10050960041, 10050970123, 10050970184, 10050970236, 10050970311, 10050980439, 10050035085, 10050960046, 10050970124, 10050970185, 10050970237, 10050970313, 10050980441, 10050035088, 10050960050, 10050970128, 10050970186, 10050970238, 10050970321, 10050980442, 10050035090, 10050960051, 10050970130, 10050970187, 10050970239, 10050970323, 10050980443, 10050035095, 10050960052, 10050970131, 10050970188, 10050970240, 10050970324, 10050980444, 10050035096, 10050960053, 10050970134, 10050970189, 10050970241, 10050970325, 10050980446, 10050035097, 10050960054, 10050970136, 10050970190, 10050970242, 10050970326, 10050980447, 10050035098, 10050960055, 10050970138, 10050970191, 10050970243, 10050970327, 10050980448, 10050035099, 10050960056, 10050970140, 10050970192, 10050970244, 10050970329, 10050980449, 10050035102, 10050960057, 10050970141, 10050970193, 10050970245, 10050970329, 10050980453, 10050035108, 10050960058, 10050970142, 10050970194, 10050970246, 10050970330, 10050980461, 10050035112, 10050960059, 10050970143, 10050970195, 10050970247, 10050970331, 10050980462, 10050035113, 10050960060, 10050970144, 10050970196, 10050970248, 10050970332, 10050980469, 10050035114, 10050960061, 10050970145, 10050970197, 10050970249, 10050970333, 10050980470, 10050035122, 10050960062, 10050970146, 10050970198, 10050970250, 10050970338, 10050980471, 10050035125, 10050960063, 10050970147, 10050970199, 10050970251, 10050970339, 10050980475, 10050035145, 10050960064, 10050970148, 10050970200, 10050970252, 10050970340 and 10050980480.
Advanced Sterilization Products is recalling Sterrad 50 Sterilizer, Product Code 10050. Low-temperature general-purpose sterilizer used to steri due to The capacitor in the vacuum pump component within the Sterrad 50 System could overheat and potentially create a hazardous condition inside the system,. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The capacitor in the vacuum pump component within the Sterrad 50 System could overheat and potentially create a hazardous condition inside the system, resulting in smoke and/or fire.
Recommended Action
Per FDA guidance
Advanced Sterilization Products (ASP) sent an "Urgent: Product Correction" letter dated January 12, 2009 to each consignee informing them of the issue and instructed them to report smoke or a burning odors in or around their STERRAD 50 System. ASP strongly recommended for consignees to follow their facility's safety protocols and if possible, immediately disconnect the STERRAD 50 System from its electrical source. Customers were instructed to contact ASP to schedule an onsite visit to investigate the issue. If the issue is caused by a malfunctioning capacitor in the vacuum pump, the firm will replace the malfunctioning component right away. To correct this situation, an ASP Field Service Engineer (FSE) will visit all customers facilities within the next sixty days to replace the capacitor in the vacuum pump on the affected STERRAD 50 System.
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 noticeDistribution
As reported by FDA
PR
Page updated: Jan 10, 2026