Z-1570-2009

Sterrad 50 Sterilizer, Product Code 10050. Low-temperature general-purpose sterilizer used to sterilize heat...

Name: Z-1570-2009 Sterrad 50 Sterilizer, Product Code 10050. Low-temperature general-purpose sterilizer used to sterilize heat...
Creator: Advanced Sterilization Products
Published: 2009-01-12
License: https://open.fda.gov/license/

Advanced Sterilization Products / initiated 2009-01-12 / Terminated

FDA source

Advanced Sterilization Products began a recall of Sterrad 50 Sterilizer, Product Code 10050. Low-temperature general-purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices on 2009-01-12. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1570-2009
Status: Terminated
Initiated: 2009-01-12
Posted: 2009-06-30
Terminated: 2011-12-28
Recalling firm: Advanced Sterilization Products
Product: Sterrad 50 Sterilizer, Product Code 10050. Low-temperature general-purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.
Product code: MLR Sterilizer, Chemical
Reason for recall: 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.
FDA root cause: Other
Action: 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.
Quantity in commerce: 1,151 units.
Distribution: Worldwide Distribution -- US, Germany, Italy, France, United Kingdom, Switzerland, Benelex, Uruguay, Venezuela, Argentina, Chile, Columbia, Belgium, Puerto Rico, Mexico, Philipines, Australia, Japan, Korea, Malaysia, Taiwan, Middle East, Peru, Canada, Czech Republic, Portugal, Spain, Sweden, Hungary, Poland, Brazil, Russia, Finland, Norway, Panama and Switzerland.
Product codes and lots: 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.

Product code MLR

K981625Class IISterrad 50 SterilizerAdvanced Sterilization Products / cleared 1999-01-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)