Advanced Sterilization Products
Medical device manufacturer in Irvin, CA.
59510(k) clearances
0PMA approvals
60recalls
Device types
- MLR Sterilizer, Chemical 17
- FRC Indicator, Biological Sterilization Process 17
- JOJ Indicator, Physical/Chemical Sterilization… 8
- MED Sterilant, Medical Devices 5
- FEB Accessories, Cleaning, For Endoscope 4
- KCT Sterilization Wrap Containers, Trays… 3
- FRG Wrap, Sterilization 3
- FLE Sterilizer, Steam 1
- FLF Sterilizer, Ethylene-Oxide Gas 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K252843 | STERRAD 100NX Sterilization System with ALLClear Technology (10104)MLR · Traditional | 04/15/2026SE |
| K250802 | STERRAD® 100NX Sterilizer with ALLClear Technology (10104)MLR · Traditional | 04/14/2025SE |
| K234084 | STERRAD Chemical Indicator (CI) Strip (14100); STERRAD® SEALSURE® Chemical Indicator…JOJ · Traditional | 07/05/2024SE |
| K234082 | STERRAD® 100NX Sterilizer with ALLClear Technology and ULTRA GI Cycle (10104)…MLR · Traditional | 07/05/2024SE |
| K220404 | STERRAD NX with ALLClear TechnologyMLR · Traditional | 05/16/2022SE |
| K212174 | STERRAD 100NX Sterilizer with ALLClear TechnologyMLR · Traditional | 10/09/2021SE |
| K163598 | Tyvek Self-Seal Pouches with STERRAD Chemical Indicator, Tyvek Rolls with STERRAD…KCT · Traditional | 07/31/2017SE |
| K162007 | STERRAD NX SterilizerMLR · Special | 02/16/2017SE |
| K160818 | STERRAD® NX Sterilizer with ALLClear TechnologyMLR · Traditional | 09/27/2016SE |
| K160903 | STERRAD 100NX Sterilizer with ALLClearTM TechnologyMLR · Traditional | 09/26/2016SE |
| K151725 | STERRAD NX Sterilizer, STERRAD 100NX SterilizerMLR · Traditional | 01/13/2016SE |
| K151971 | STERRAD CYCLESURE 24 Biological IndicatorFRC · Traditional | 10/29/2015SE |
| K142454 | STERRAD NX Sterilizer, STERRAD 100NX SterilizerMLR · Traditional | 04/03/2015SE |
| K140977 | Evotech EcrFEB · Traditional | 12/22/2014SE |
| K141693 | Tyvek® Pouch/Roll with STERRAD® Chemical IndicatorFRG · Traditional | 12/19/2014SE |
| K130263 | Sterrad 50/100S/200 Test PackFRC · Traditional | 03/28/2014SE |
| K123017 | Sterrad Cyclesure 24 Biological Indicator Model 14324FRC · Special | 12/26/2012SE |
| K112087 | Tyvek Self-Seal Pouches ,Tyvek Heat-Seal RollsKCT · Traditional | 10/15/2012SE |
| K122044 | Sterrad(R) Cyclesure(R) 24 Biological IndicatorFRC · Special | 10/04/2012SE |
| K111519 | Sterrad Sealsure Chemical Indicator Tape Model 14202JOJ · Traditional | 10/03/2012SE |
| K111518 | Sterrad Chemial Indicator Strip Model 14100JOJ · Traditional | 10/03/2012SE |
| K111391 | Sterrad (R) 100NX Duo Cycle Test PackFRC · Traditional | 09/26/2012SE |
| K111375 | Sterrad (R) Cyclesure (R) 24 Biological IndicatorFRC · Traditional | 09/14/2012SE |
| K111377 | Sterrad(R) 100NX Sterilizer Duo CycleMLR · Traditional | 09/13/2012SE |
| K103210 | Tyvek Self-Seal Pouches with Sterrad, Tyvek Rolls with Sterrad, Tyvek Heat-Seal with…FRG · Traditional | 06/06/2011SE |
| K103219 | Sterrad Sealsure Chemical Indicator TapeJOJ · Traditional | 04/01/2011SE |
| K103218 | Sterrad Chemical Indicator StripJOJ · Traditional | 04/01/2011SE |
| K092622 | Sterrad 100NX Sterilizer Express CycleMLR · Traditional | 03/04/2011SE |
| K103222 | Sterrad Cyclesure Biological IndicatorFRC · Traditional | 02/25/2011SE |
| K092755 | Sterraad 100NX Express Cycle Test PackFRC · Traditional | 02/25/2011SE |
| K102884 | Sterrad Cyclesure 24 Biological IndicatorFRC · Traditional | 01/28/2011SE |
| K082392 | Evotech Endoscope Cleaner and ReprocessorFEB · Special | 11/13/2008SE |
| K071537 | Sterrad 100NX Test PackFRC · Traditional | 12/18/2007SE |
| K071385 | Sterrad 100NX SterilizerMLR · Traditional | 11/29/2007SE |
| K071014 | Modification to Sterrad Cyclesure Biological IndicatorFRC · Special | 05/24/2007SE |
| K061899 | Evotech Integrated Endoscope Disinfection SystemFEB · Traditional | 10/26/2006SE |
| K051643 | Sterrad Sterilizer Cyclesure Test PackFRC · Traditional | 08/19/2005SE |
| K042450 | Sterrad NX Challenge PackFRC · Traditional | 05/12/2005SE |
| K042116 | Sterrad NX SterilizerMLR · Traditional | 04/22/2005SE |
| K032959 | Cidex Opa ConcentrateMED · Traditional | 04/04/2005SE |
| K040883 | Evotech Integrated Endoscope Disinfection SystemFEB · Traditional | 03/15/2005SE |
| K040742 | Modification to Sterrad Sealsure Chemical Indicator TapeJOJ · Special | 04/02/2004SE |
| K030429 | Sterrad 200 SterilizerMLR · Traditional | 08/18/2003SE |
| K031226 | Sterrad Cyclesure Biological IndicatorFRC · Special | 05/02/2003SE |
| K023290 | Sterrad 50 & Sterrad 100S SterilizersFLF · Traditional | 04/03/2003SE |
| K030004 | 0.55% Orth-Phthalaldehyde SolutionMED · Traditional | 02/27/2003SE |
| K022441 | Sterrad Sealsure Chemical Indicator TapeJOJ · Traditional | 10/08/2002SE |
| K013003 | Aptimax Instrument Tray, Instrument Mat and Instrument HolderFRG · Traditional | 08/28/2002SE |
| K994055 | Sterrad Cyclesure Biological IndicatorFRC · Traditional | 02/13/2002SE |
| K002401 | Cidex Opa Solution (0.55% Orthro-Phthalaldehyde Solution)MED · Special | 08/29/2000SE |
| K991999 | Sterrad 100S SterilizerMLR · Traditional | 06/15/2000SE |
| K993775 | Sterrad Bi Test PackFRC · Traditional | 06/01/2000SE |
| K001381 | Cidex Opa SolutionMED · Special | 05/17/2000SE |
| K991487 | Cidex Opa SolutionMED · Traditional | 10/08/1999SE |
| K991675 | Modification of: Sterrad Bi Test PackFRC · Special | 06/15/1999SE |
| K981625 | Sterrad 50 SterilizerMLR · Traditional | 01/11/1999SE |
| K954142 | Sterradd Sterilization SystemFLE · Traditional | 06/06/1997SE |
| K951295 | Sterrad Sterilization PouchKCT · Traditional | 05/19/1995SE |
| K945190 | Sterrad Chemical Indicator TapeJOJ · Traditional | 12/29/1994SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-1197-2017 Class II | STERRAD NX Sterilization System, Product Code: 10033, 10033-002Advanced Sterilization Products (ASP) has identified that in a rare sequence of events following an external… | 01/09/2017Terminated |
| Z-0965-2017 Class II | EVOTECH Endoscope Cleaner and Reprocessor System 208V, Product Code: 50004 The EVOTECH…Advanced Sterilization Products (ASP) is recalling the EVOTECH Endoscope Cleaner and Reprocessor System… | 09/27/2016Terminated |
| Z-2774-2015 Class II | CIDEX OPA Solution, P/N 20390 for use as a high level disinfectant for reprocessing heat…Advanced Sterilization Products (ASP) is reminding all CIDEX OPA Solution customers to follow the warnings… | 08/10/2015Terminated |
| Z-2459-2015 Class II | CIDEX Activated Dialdehyde Solution, 4 bottles/case, P/N: 2266Advanced Sterilization Products (ASP) is recalling the CIDEX Activated Dialdehyde Solution because it may… | 07/27/2015Terminated |
| Z-2375-2015 Class II | Wall Chart for STERRAD 100NX System, P/N 10104. The STERRAD 100NX Sterilizer is designed…Advanced Sterilization PRoducts (ASP) is recalling the Wall Chart for STERRAD 100NX System because it… | 07/17/2015Terminated |
| Z-1715-2015 Class II | EVOTECH Endoscope Cleaner and Reprocessing System 220-230V, P/N 50004-002. The ASP…Advanced Sterilization Products (ASP) is recalling the EVOTECH Endoscope Cleaner and Reprocessor (ECR)… | 05/11/2015Terminated |
| Z-1714-2015 Class II | EVOTECH Endoscope Cleaner and Reprocessing System 208V, P/N 50004. The ASP EVOTECH ECR…Advanced Sterilization Products (ASP) is recalling the EVOTECH Endoscope Cleaner and Reprocessor (ECR)… | 05/11/2015Terminated |
| Z-1312-2015 Class II | Tyvek Pouch/Roll with STERRAD Chemical Indicator, P/N 12425Advanced Sterilization Products (ASP) is recalling the Tyvek Rolls with STERRAD Chemical Indicator because… | 12/24/2014Terminated |
| Z-0846-2015 Class II | STERRAD 100NX, Product Code 10144 The STERRAD Cassettes are used on STERRAD…Advanced Sterilization Products is recalling the STERRAD System cassettes because the the leak indicator on… | 11/04/2014Terminated |
| Z-0845-2015 Class II | STERRAD NX, Product Code 10133 The STERRAD Cassettes are used on STERRAD Sterilization…Advanced Sterilization Products is recalling the STERRAD System cassettes because the the leak indicator on… | 11/04/2014Terminated |
| Z-0844-2015 Class II | STERRAD 200, Product Code 10118 The STERRAD Cassettes are used on STERRAD Sterilization…Advanced Sterilization Products is recalling the STERRAD System cassettes because the the leak indicator on… | 11/04/2014Terminated |
| Z-0843-2015 Class II | STERRAD 100S, Product Code 10113. The STERRAD Cassettes are used on STERRAD…Advanced Sterilization Products is recalling the STERRAD System cassettes because the the leak indicator on… | 11/04/2014Terminated |
| Z-0842-2015 Class II | STERRAD 50, Product Code 10114. The STERRAD Cassettes are used on STERRAD Sterilization…Advanced Sterilization Products is recalling the STERRAD System cassettes because the the leak indicator on… | 11/04/2014Terminated |
| Z-0746-2014 Class II | STERRAD 100S Sterilization System, Product Code: 10101 The STERRAD 100S Sterilization…Advanced Sterilization Products (ASP) is recalling the STERRAD NX, STERRAD 50, and STERRAD 100S… | 12/16/2013Terminated |
| Z-0745-2014 Class II | STERRAD 50 Sterilization System, Product Code: 10050 The STERRAD 50 Sterilization System…Advanced Sterilization Products (ASP) is recalling the STERRAD NX, STERRAD 50, and STERRAD 100S… | 12/16/2013Terminated |
| Z-0744-2014 Class II | STERRAD NX Sterilization System, Product Code: 10033 The STERRAD NX Sterilization System…Advanced Sterilization Products (ASP) is recalling the STERRAD NX, STERRAD 50, and STERRAD 100S… | 12/16/2013Terminated |
| Z-0604-2014 Class II | STERRAD Cyclesure Biological Indicator (BI, Part No. 14324. Intended to be used as a…Advanced Sterilization Products (ASP) is recalling the STERRAD Cyclesure Biological Indicator (BI) because… | 11/26/2013Terminated |
| Z-0403-2014 Class II | STERRAD NX, Product Code: 10033 The STERRAD Steri lization System is a low temperature…Advanced Sterilization Products (ASP) is recalling the STERRAD NX and STERRAD 100NX sterilization systems… | 11/11/2013Terminated |
| Z-0402-2014 Class II | STERRAD 100NX, Product Code: 10104 The STERRAD Steri lization System is a low…Advanced Sterilization Products (ASP) is recalling the STERRAD NX and STERRAD 100NX sterilization systems… | 11/11/2013Terminated |
| Z-0190-2014 Class II | Sterrad 100NX, Product Code: 10104. Used to sterilize heat and moisture sensitive…Advanced Sterilization Products (ASP) is recalling the Sterrad 100NX Sterilizer some healthcare workers… | 10/18/2013Terminated |
| Z-0434-2014 Class III | STERITITE Containers: STERITITE Container Kit, 1/4 size, 3" high, product code: 13902…Advanced Sterilization Products (ASP) is recalling the SteriTite containers because they do not have… | 10/03/2013Terminated |
| Z-0044-2014 Class II | STERRAD 100NX Cassettes The STERRAD Sterilization System is a low temperature general…Advanced Sterilization Products (ASP) is recalling the three lots (13F049, 13F050, 13F051) STERRAD 100NX… | 09/18/2013Terminated |
| Z-0043-2014 Class II | STERRAD 200 Sterilizer (Single Door), Part Number: 10201. STERRAD 200 Sterilizer (Double…Advanced Sterilization Products (ASP) is recalling the STERRAD 200 Sterilization System because it may emit… | 09/18/2013Terminated |
| Z-2174-2013 Class II | STERRAD 100NX Cassettes, Product Code: 10144 The STERRAD Sterilization System is a low…The recall of the STERRAD 100NX Cassettes was initiated because Advanced Sterilization Products (ASP) does… | 07/25/2013Terminated |
| Z-1180-2013 Class II | STERRAD CYCLESURE 24 Biological Indicator (BI) The STERRAD CYCLESURE 24 Biological…Advanced Sterilization Products is recalling certain lots of STERRAD CYCLESURE 24 Biological Indicator… | 04/22/2013Terminated |
| Z-1150-2013 Class II | EVOTECH Endoscope Cleaner and Reprocessor System, P/N 50004. Designed to automatically…Advanced Sterilization Products (ASP) is recalling the EVOTECH Endoscope Cleaner and Reprocessor (ECR)… | 03/28/2013Terminated |
| Z-1123-2013 Class II | EVOTECH Endoscope Cleaner & Reprocessor System, P/N 50004 Designed to automatically…Advanced Sterilization Products (ASP) has determined that a limited number of EVOTECH ECRs manufactured… | 03/22/2013Terminated |
| Z-1027-2013 Class II | STERRAD 200 Sterilization System, P/N 10201 Product Usage: The STERRAD 200 Sterilization…The recall was initiated because Advanced Sterilization Products (ASP) has determined that the STERRAD 100NX… | 03/22/2013Terminated |
| Z-1026-2013 Class II | STERRAD 100NX Sterilization System, P/N 10104 Product Usage: The STERRAD 100NX…The recall was initiated because Advanced Sterilization Products (ASP) has determined that the STERRAD 100NX… | 03/22/2013Terminated |
| Z-0520-2013 Class II | STERRAD CYCLESURE 24 Biological Indicator (BI) product, P/N 14324. Validation kits with…Advanced Sterilization Products (ASP) is recalling all lots of Sterrad Cyclesure 24 Biological Indicator… | 10/03/2012Terminated |
| Z-0661-2013 Class II | STERRAD NX Cassettes, P/N 10133. The STERRAD NX sterilizations systems are…Advanced Sterilization Products is recalling three lots of STERRAD NX System Cassettes because it does not… | 09/20/2012Terminated |
| Z-2100-2012 Class II | STERRAD Cyclesure Biological Indicator (BI), P/N 14324 are sold in cases, packaged as…Advanced Sterilization Products (ASP) is recalling certain lots of the STERRAD CYCLESURE 24 Biological… | 06/28/2012Terminated |
| Z-2338-2012 Class III | STERRAD NX Cassette, Batch # 12A078. The STERRAD 100S and STERRAD NX sterilizations…Advanced Sterilization Products (ASP) is recalling (removing) the Sterrad 100S and Sterrad NX System… | 06/19/2012Terminated |
| Z-2337-2012 Class III | STERRAD 100S Cassette, Batch # 12A077. The STERRAD 100S and STERRAD NX sterilizations…Advanced Sterilization Products (ASP) is recalling (removing) the Sterrad 100S and Sterrad NX System… | 06/19/2012Terminated |
| Z-2276-2012 Class II | CIDEX OPA, High Level Disinfectant Solution, Glutaraldehyde-free (0.55%…The recall was initiated because Advanced Sterilization Products has discovered instances of missing labels… | 06/01/2012Terminated |
| Z-0998-2013 Class II | STERRAD 200 System Carriage, P/N 10208. Used as a tool to expedite loading and unloading…Advanced Sterilization Products (ASP) is recalling the STERRAD 200 System Carriage because it can… | 03/13/2012Terminated |
| Z-1773-2012 | Sterrad Cyclesure 24 Biological Indicator, P/N: 14324 The STERRAD CYCLESURE 24…The recall was initiated by Advanced Sterilization Products because they recently determined that certain… | 02/17/2012Terminated |
| Z-0741-2012 | STERRAD 200 Sterilizer, Hydrogen Peroxide Gas Plasma Sterilizer, Chemical Sterilizer.…ASP determined that an internal filter in the vacuum pump on the STERRAD 200 System is subject to wear over… | 01/23/2012Terminated |
| Z-1393-2011 | Tyvek Self-Seal Pouch with STERRAD Chemical Indicator 12332. Intended to be used to…The recall was initiated after Advanced Sterilization Products (ASP) discovered a non-conforming lot. The… | 06/23/2010Terminated |
| Z-0628-2011 | ASP Automatic Endoscope Reprocessor (AER), Product Code: 20300 & 20301 The AER is a…The recall was initiated because Advanced Sterilization Products (ASP) received three customer reports of… | 02/19/2010Terminated |
| Z-0066-2010 | Sterrad CycleSure Biological Indicator, Product Code 14324. The Sterrad CycleSure…Biological Indicator indicating a positive result does not maintain yellow color for the entire incubation… | 06/23/2009Terminated |
| Z-1420-2009 | STERRAD NX Sterilization System Product Code 10033 The STERRAD Sterilization System is a…ASP has identified a secondary, lower-occurring cause of oil mist within certain STERRAD NX Systems and… | 03/09/2009Terminated |
| Z-1419-2009 | STERRAD 50 Sterilization System Product Code 10050 The STERRAD Sterilization System is a…ASP has identified a secondary, lower-occurring cause of oil mist within certain STERRAD NX Systems and… | 03/09/2009Terminated |
| Z-1570-2009 | Sterrad 50 Sterilizer, Product Code 10050. Low-temperature general-purpose sterilizer…The capacitor in the vacuum pump component within the Sterrad 50 System could overheat and potentially… | 01/12/2009Terminated |
| Z-0468-2012 | STERRAD NX Sterilizer Hydrogen Peroxide Gas Plasma Sterilizer Product Code 10133. The…Advanced Sterilization Products (ASP) has discovered a defect in the barcode labeling of the STERRAD NX… | 12/10/2008Terminated |
| Z-0340-2009 | STERRAD 100S Sterilizer (Product Code 10101). The sterilizer includes software and…1) Inability of the sterilizer to detect when an injection takes place without hydrogen peroxide being… | 10/17/2008Terminated |
| Z-0484-2009 | STERRAD NX Sterilizer, Product Code 10033 Low temperature sterilizers that use hydrogen…ASP has discovered a component defect in some of the UV lamp power supplies used in certain STERRAD NX… | 10/07/2008Terminated |
| Z-0281-2009 | ASP Automatic Endoscope Reprocessor, AER Plus Product Code 20300 and AER with printer…Residual high-level disinfectant solution remaining in endoscopes that have been reprocessed in the ASP… | 09/11/2008Terminated |
| Z-1632-2008 | STERRAD 100NX Sterilizer, Product Code 10104 Used to sterilize heat and moisture…Oil mist filter fails allowing oil mist to be emitted into the vicinity of the sterilizer, which may result… | 02/25/2008Terminated |
| Z-1631-2008 | STERRAD NX Sterilizer, Product Code 10033 Used to sterilize heat and moisture sensitive…Oil mist filter fails allowing oil mist to be emitted into the vicinity of the sterilizer, which may result… | 02/25/2008Terminated |
| Z-1630-2008 | STERRAD 200 Sterilization System, Product Code 10201 Used to sterilize heat and moisture…Oil mist filter fails allowing oil mist to be emitted into the vicinity of the sterilizer, which may result… | 02/25/2008Terminated |
| Z-1629-2008 | STERRAD 50 Sterilization System, Product Code 10050 Used to sterilize heat and moisture…Oil mist filter fails allowing oil mist to be emitted into the vicinity of the sterilizer, which may result… | 02/25/2008Terminated |
| Z-1628-2008 | STERRAD 100S Sterilization System, Product Code 10101 Used to sterilize heat and…Oil mist filter fails allowing oil mist to be emitted into the vicinity of the sterilizer, which may result… | 02/25/2008Terminated |
| Z-1369-2008 | EvoTech Endoscope Cleaner and Reprocessor, Product Code 50004-002 Indicated for use with…Cleaning cycles are being cancelled. Specific issues are: a) Water heater tank is rusting resulting in the… | 02/13/2008Terminated |
| Z-1368-2008 | EvoTech Endoscope Cleaner & Reprocessor, Product Code 50004 Indicated for use with high…Cleaning cycles are being cancelled. Specific issues are: a) Water heater tank is rusting resulting in the… | 02/13/2008Terminated |
| Z-0848-2008 | STERRAD NX Sterilizer, Product Code: 10033, Advanced Sterilization Products, Irvine, CAUser Guide Update: based on user reports about contact with residual hydrogen peroxide from instruments… | 11/12/2007Terminated |
| Z-0847-2008 | STERRAD 200 Sterilizer, Product Code: 10201, Advanced Sterilization Products, Irvine, CAUser Guide Update: based on user reports about contact with residual hydrogen peroxide from instruments… | 11/12/2007Terminated |
| Z-0846-2008 | STERRAD 50 Sterilizer, Product Code:10050, Advanced Sterilization Products, Irvine, CAUser Guide Update: based on user reports about contact with residual hydrogen peroxide from instruments… | 11/12/2007Terminated |
| Z-0845-2008 | STERRAD 100S Sterilizer, Product Code: 10101, Advanced Sterilization Products, Irvine, CAUser Guide Update: based on user reports about contact with residual hydrogen peroxide from instruments… | 11/12/2007Terminated |
| Z-0844-2008 | STERRAD Sterilizers ( Models 100S, 50, 200) Compatible Medical Device Reference List for…Outdated Compatibility Lists: Recalling firm has decided to discontinue dissemination of Compatible Medical… | 11/12/2007Terminated |