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Advanced Sterilization Products

69 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
STERRAD NX Sterilization System, Product Code: 10033, 10033-002 recall (Z-1197-2017)Advanced Sterilization Products2017-02-14
EVOTECH Endoscope Cleaner and Reprocessor System 208V, Product Code: 50004 The EVOTECH ECR recall (Z-0965-2017)Advanced Sterilization Products2017-01-09
CIDEX OPA Solution, P/N 20390 for use as a high level disinfectant for reprocessing heat s recall (Z-2774-2015)Advanced Sterilization Products2015-09-16
CIDEX Activated Dialdehyde Solution, 4 bottles/case, P/N: 2266 recall (Z-2459-2015)Advanced Sterilization Products2015-08-25
Wall Chart for STERRAD 100NX System, P/N 10104. The STERRAD 100NX Sterilizer is designed f recall (Z-2375-2015)Advanced Sterilization Products2015-08-13
EVOTECH Endoscope Cleaner and Reprocessing System 208V, P/N 50004. The ASP EVOTECH ECR End recall (Z-1714-2015)Advanced Sterilization Products2015-06-05
EVOTECH Endoscope Cleaner and Reprocessing System 220-230V, P/N 50004-002. The ASP EVOTECH recall (Z-1715-2015)Advanced Sterilization Products2015-06-05
Tyvek Pouch/Roll with STERRAD Chemical Indicator, P/N 12425 recall (Z-1312-2015)Advanced Sterilization Products2015-03-23
STERRAD 50, Product Code 10114. The STERRAD Cassettes are used on STERRAD Sterilization Sy recall (Z-0842-2015)Advanced Sterilization Products2014-12-22
STERRAD 100S, Product Code 10113. The STERRAD Cassettes are used on STERRAD Sterilization recall (Z-0843-2015)Advanced Sterilization Products2014-12-22
STERRAD 200, Product Code 10118 The STERRAD Cassettes are used on STERRAD Sterilization Sy recall (Z-0844-2015)Advanced Sterilization Products2014-12-22
STERRAD NX, Product Code 10133 The STERRAD Cassettes are used on STERRAD Sterilization Sys recall (Z-0845-2015)Advanced Sterilization Products2014-12-22
STERRAD 100NX, Product Code 10144 The STERRAD Cassettes are used on STERRAD Sterilization recall (Z-0846-2015)Advanced Sterilization Products2014-12-22
STERRAD NX Sterilization System, Product Code: 10033 The STERRAD NX Sterilization System i recall (Z-0744-2014)Advanced Sterilization Products2014-01-14
STERRAD 50 Sterilization System, Product Code: 10050 The STERRAD 50 Sterilization System i recall (Z-0745-2014)Advanced Sterilization Products2014-01-14
STERRAD 100S Sterilization System, Product Code: 10101 The STERRAD 100S Sterilization Syst recall (Z-0746-2014)Advanced Sterilization Products2014-01-14
STERRAD Cyclesure Biological Indicator (BI, Part No. 14324. Intended to be used as a stand recall (Z-0604-2014)Advanced Sterilization Products2013-12-28
STERITITE Containers: STERITITE Container Kit, 1/4 size, 3" high, product code: 13902; STE recall (Z-0434-2014)Advanced Sterilization Products2013-12-03
STERRAD 100NX, Product Code: 10104 The STERRAD Steri lization System is a low temperature recall (Z-0402-2014)Advanced Sterilization Products2013-11-26
STERRAD NX, Product Code: 10033 The STERRAD Steri lization System is a low temperature gen recall (Z-0403-2014)Advanced Sterilization Products2013-11-26
Sterrad 100NX, Product Code: 10104. Used to sterilize heat and moisture sensitive reusable recall (Z-0190-2014)Advanced Sterilization Products2013-11-08
STERRAD 200 Sterilizer (Single Door), Part Number: 10201. STERRAD 200 Sterilizer (Double D recall (Z-0043-2014)Advanced Sterilization Products2013-10-22
STERRAD 100NX Cassettes The STERRAD Sterilization System is a low temperature general purp recall (Z-0044-2014)Advanced Sterilization Products2013-10-22
STERRAD 100NX Cassettes, Product Code: 10144 The STERRAD Sterilization System is a low tem recall (Z-2174-2013)Advanced Sterilization Products2013-09-10
STERRAD CYCLESURE 24 Biological Indicator (BI) The STERRAD CYCLESURE 24 Biological Indicat recall (Z-1180-2013)Advanced Sterilization Products2013-04-26
EVOTECH Endoscope Cleaner and Reprocessor System, P/N 50004. Designed to automatically cle recall (Z-1150-2013)Advanced Sterilization Products2013-04-18
EVOTECH Endoscope Cleaner & Reprocessor System, P/N 50004 Designed to automatically clean recall (Z-1123-2013)Advanced Sterilization Products2013-04-15
STERRAD 100NX Sterilization System, P/N 10104 Product Usage: The STERRAD 100NX Sterilizati recall (Z-1026-2013)Advanced Sterilization Products2013-03-30
STERRAD 200 Sterilization System, P/N 10201 Product Usage: The STERRAD 200 Sterilization S recall (Z-1027-2013)Advanced Sterilization Products2013-03-30
STERRAD 200 System Carriage, P/N 10208. Used as a tool to expedite loading and unloading p recall (Z-0998-2013)Advanced Sterilization Products2013-03-26
STERRAD NX Cassettes, P/N 10133. The STERRAD NX sterilizations systems are low-temperature recall (Z-0661-2013)Advanced Sterilization Products2013-01-09
STERRAD CYCLESURE 24 Biological Indicator (BI) product, P/N 14324. Validation kits with St recall (Z-0520-2013)Advanced Sterilization Products2012-12-12
STERRAD 100S Cassette, Batch # 12A077. The STERRAD 100S and STERRAD NX sterilizations syst recall (Z-2337-2012)Advanced Sterilization Products2012-09-07
STERRAD NX Cassette, Batch # 12A078. The STERRAD 100S and STERRAD NX sterilizations system recall (Z-2338-2012)Advanced Sterilization Products2012-09-07
CIDEX OPA, High Level Disinfectant Solution, Glutaraldehyde-free (0.55% ortho-phthaladehyd recall (Z-2276-2012)Advanced Sterilization Products2012-08-27
STERRAD Cyclesure Biological Indicator (BI), P/N 14324 are sold in cases, packaged as part recall (Z-2100-2012)Advanced Sterilization Products2012-07-27
Sterrad Cyclesure 24 Biological Indicator, P/N: 14324 The STERRAD CYCLESURE 24 Biological recall (Z-1773-2012)Advanced Sterilization Products2012-06-06
STERRAD 200 Sterilizer, Hydrogen Peroxide Gas Plasma Sterilizer, Chemical Sterilizer. STER recall (Z-0741-2012)Advanced Sterilization Products2012-01-13
STERRAD NX Sterilizer Hydrogen Peroxide Gas Plasma Sterilizer Product Code 10133. The STER recall (Z-0468-2012)Advanced Sterilization Products2012-01-11
Tyvek Self-Seal Pouch with STERRAD Chemical Indicator 12332. Intended to be used to contai recall (Z-1393-2011)Advanced Sterilization Products2011-02-22
ASP Automatic Endoscope Reprocessor (AER), Product Code: 20300 & 20301 The AER is a machin recall (Z-0628-2011)Advanced Sterilization Products2010-12-16
Sterrad CycleSure Biological Indicator, Product Code 14324. The Sterrad CycleSure Biologic recall (Z-0066-2010)Advanced Sterilization Products2009-10-20
Sterrad 50 Sterilizer, Product Code 10050. Low-temperature general-purpose sterilizer used recall (Z-1570-2009)Advanced Sterilization Products2009-06-30
STERRAD 50 Sterilization System Product Code 10050 The STERRAD Sterilization System is a l recall (Z-1419-2009)Advanced Sterilization Products2009-06-15
STERRAD NX Sterilization System Product Code 10033 The STERRAD Sterilization System is a l recall (Z-1420-2009)Advanced Sterilization Products2009-06-15
STERRAD NX Sterilizer, Product Code 10033 Low temperature sterilizers that use hydrogen pe recall (Z-0484-2009)Advanced Sterilization Products2008-12-02
STERRAD 100S Sterilizer (Product Code 10101). The sterilizer includes software and hardwar recall (Z-0340-2009)Advanced Sterilization Products2008-11-21
ASP Automatic Endoscope Reprocessor, AER Plus Product Code 20300 and AER with printer Prod recall (Z-0281-2009)Advanced Sterilization Products2008-11-07
EvoTech Endoscope Cleaner & Reprocessor, Product Code 50004 Indicated for use with high le recall (Z-1368-2008)Advanced Sterilization Products2008-08-08
EvoTech Endoscope Cleaner and Reprocessor, Product Code 50004-002 Indicated for use with h recall (Z-1369-2008)Advanced Sterilization Products2008-08-08
STERRAD 100S Sterilization System, Product Code 10101 Used to sterilize heat and moisture recall (Z-1628-2008)Advanced Sterilization Products2008-08-08
STERRAD 50 Sterilization System, Product Code 10050 Used to sterilize heat and moisture se recall (Z-1629-2008)Advanced Sterilization Products2008-08-08
STERRAD 200 Sterilization System, Product Code 10201 Used to sterilize heat and moisture s recall (Z-1630-2008)Advanced Sterilization Products2008-08-08
STERRAD NX Sterilizer, Product Code 10033 Used to sterilize heat and moisture sensitive re recall (Z-1631-2008)Advanced Sterilization Products2008-08-08
STERRAD 100NX Sterilizer, Product Code 10104 Used to sterilize heat and moisture sensitive recall (Z-1632-2008)Advanced Sterilization Products2008-08-08
STERRAD 100S Sterilizer, Product Code: 10101, Advanced Sterilization Products, Irvine, CA recall (Z-0845-2008)Advanced Sterilization Products2008-02-08
STERRAD 50 Sterilizer, Product Code:10050, Advanced Sterilization Products, Irvine, CA recall (Z-0846-2008)Advanced Sterilization Products2008-02-08
STERRAD 200 Sterilizer, Product Code: 10201, Advanced Sterilization Products, Irvine, CA recall (Z-0847-2008)Advanced Sterilization Products2008-02-08
STERRAD NX Sterilizer, Product Code: 10033, Advanced Sterilization Products, Irvine, CA recall (Z-0848-2008)Advanced Sterilization Products2008-02-08
STERRAD Sterilizers ( Models 100S, 50, 200) Compatible Medical Device Reference List for U recall (Z-0844-2008)Advanced Sterilization Products2008-02-07
Vaporizer Plate Vaporizer Plate Consumable accessory used with the STERRAD 100 and the STE recall (Z-0197-06)Advanced Sterilization Products2005-11-24
Cidexplus Solution Test Strips recall (Z-0779-05)Advanced Sterilization Products2005-04-27
CIDEX OPA Solution, ortho-Phthalaldehyde Solution recall (Z-0051-05)Advanced Sterilization Products2004-10-28
Gluteraldehyde Concentration Indicators ''Browne GA Indicator for CIDEX PLUS Products'' recall (Z-1479-04)Advanced Sterilization Products2004-09-21
Gluteraldehyde Concentration Indicators ''Browne GA Indicator for CIDEX Products'' recall (Z-1480-04)Advanced Sterilization Products2004-09-21
Ortho-phthaladehyde Concentration Indicator Browne CIDEX OPA Indicator recall (Z-1481-04)Advanced Sterilization Products2004-09-21
Cidex Plus Test Strips recall (Z-0375-04)Advanced Sterilization Products2004-01-29
Cidex Solution Test Strips Browne GA Indicators for Cidex Solution Test Strips. recall (Z-0694-03)Advanced Sterilization Products2003-03-29
Cidex Plus Solution Test Strips recall (Z-0695-03)Advanced Sterilization Products2003-03-29

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Every clearance here is in the API, with alerts when new ones post.