Data / Medical devices / United States / Advanced Sterilization Products
Advanced Sterilization Products: FDA-registered device maker in Irvine, CA, United States, 40 510(k) clearances
Advanced Sterilization Products is registered with the FDA (registration 2084725) in Irvine, CA, United States. It lists 15 device types. The FDA files 40 510(k) clearances under its listings, the newest dated January 29, 2026. 47 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 2084725
- FEI number
- 3003662624
- Address
- 33 Technology Drive, Irvine, CA, United States, 92618
- Owner or operator
- Advanced Sterilization Products (9068155)
- Roles
- Complaint file establishment, Manufacturer, Remanufacturer, Repackager or relabeler, Specification developer
- First device listed
- July 8, 1999
- Registered through
- 2026
- Brand names listed
- AEROFLEX AER, AUTOSURE MRC Reagent, AEROZYME and AERO-OPA (28000, 23300, 25520, 25410), APTIMAX Instrument Tray Holders (994XX), APTIMAX Instrument Tray for ULTRA GI Cycle (011077), ASP ACCESS (53001), Aptimax Instrument Tray (138XX), CIDEX OPA Test Strips (20392, 20393), CIDEX OPA Test Strips (2927), CIDEX OPA Concentrate (20398) and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 29, 2026 | K251354 | UV Smart D60 | SCS | Substantially Equivalent | UV Smart Technologies B.V. | accessdata.fda.gov |
| July 5, 2024 | K234084 | STERRAD Chemical Indicator (CI) Strip (14100); STERRAD® SEALSURE® Chemical Indicator (CI) Tape (14202NL); STERRAD VELOCITY Biological Indicator (BI) (43210) (60 count); STERRAD VELOCITY Biological Indicator (BI) (43210-30)(30 count); STERRAD VELOCITY Reader (43220); ULTRA GI Process Challenge Device (PCD) (43400)(30 count) | JOJ | Substantially Equivalent | Advanced Sterilization Products, Inc. | accessdata.fda.gov |
| July 5, 2024 | K234082 | STERRAD® 100NX Sterilizer with ALLClear Technology and ULTRA GI Cycle (10104); APTIMAX Instrument Tray for ULTRA GI Cycle (011077) | MLR | Substantially Equivalent | Advanced Sterilization Products | accessdata.fda.gov |
| May 16, 2022 | K220404 | STERRAD NX with ALLClear Technology | MLR | Substantially Equivalent | Advanced Sterilization Products, Inc. | accessdata.fda.gov |
| October 9, 2021 | K212174 | STERRAD 100NX Sterilizer with ALLClear Technology | MLR | Substantially Equivalent | Advanced Sterilization Products, Inc. | accessdata.fda.gov |
| January 23, 2020 | K192025 | STERRAD VELOCITY Biological Indicator/Process Challenge Device and Reader | FRC | Substantially Equivalent | Advanced Sterilization Products (Asp) | accessdata.fda.gov |
| April 23, 2019 | K181472 | AEROFLEX(TM) Automatic Endoscope Reprocessor with AUTOSURE(TM) MRC Monitor | FEB | Substantially Equivalent | Advanced Sterilization Products (Asp) | accessdata.fda.gov |
| December 27, 2018 | K182404 | STERRAD VELOCITY Biological Indicator | FRC | Substantially Equivalent | Advanced Sterilization Products (Asp) | accessdata.fda.gov |
| July 31, 2017 | K163598 | Tyvek Self-Seal Pouches with STERRAD Chemical Indicator, Tyvek Rolls with STERRAD Chemical Indicator, Tyvek Heat-Seal Pouches with STERRAD Chemical Indicator | KCT | Substantially Equivalent | Advanced Sterilization Products | accessdata.fda.gov |
| June 20, 2017 | K170039 | STERRAD VELOCITY Biological Indictator and Reader | FRC | Substantially Equivalent | Advanced Sterilization Products (Asp) | accessdata.fda.gov |
| September 27, 2016 | K160818 | STERRAD® NX Sterilizer with ALLClear Technology | MLR | Substantially Equivalent | Advanced Sterilization Products | accessdata.fda.gov |
| September 26, 2016 | K160903 | STERRAD 100NX Sterilizer with ALLClearTM Technology | MLR | Substantially Equivalent | Advanced Sterilization Products | accessdata.fda.gov |
| July 20, 2016 | K152189 | EVOTECH ECR | FEB | Substantially Equivalent | Advanced Sterilization Products (Asp) | accessdata.fda.gov |
| April 3, 2015 | K142454 | STERRAD NX Sterilizer, STERRAD 100NX Sterilizer | MLR | Substantially Equivalent | Advanced Sterilization Products | accessdata.fda.gov |
| December 22, 2014 | K140977 | EVOTECH ECR | FEB | Substantially Equivalent | Advanced Sterilization Products | accessdata.fda.gov |
| December 19, 2014 | K141693 | Tyvek® Pouch/Roll with STERRAD® Chemical Indicator | FRG | Substantially Equivalent | Advanced Sterilization Products | accessdata.fda.gov |
| October 15, 2012 | K112087 | TYVEK SELF-SEAL POUCHES ,TYVEK HEAT-SEAL ROLLS | KCT | Substantially Equivalent | Advanced Sterilization Products | accessdata.fda.gov |
| October 3, 2012 | K111519 | STERRAD SEALSURE CHEMICAL INDICATOR TAPE MODEL 14202 | JOJ | Substantially Equivalent | Advanced Sterilization Products | accessdata.fda.gov |
| October 3, 2012 | K111518 | STERRAD CHEMIAL INDICATOR STRIP MODEL 14100 | JOJ | Substantially Equivalent | Advanced Sterilization Products | accessdata.fda.gov |
| September 13, 2012 | K111377 | STERRAD(R) 100NX STERILIZER DUO CYCLE | MLR | Substantially Equivalent | Advanced Sterilization Products | accessdata.fda.gov |
| June 6, 2011 | K103210 | TYVEK SELF-SEAL POUCHES WITH STERRAD, TYVEK ROLLS WITH STERRAD, TYVEK HEAT-SEAL WITH STERRAD CHEMICAL INDICATORS | FRG | Substantially Equivalent | Advanced Sterilization Products | accessdata.fda.gov |
| April 1, 2011 | K103219 | STERRAD SEALSURE CHEMICAL INDICATOR TAPE | JOJ | Substantially Equivalent | Advanced Sterilization Products | accessdata.fda.gov |
| April 1, 2011 | K103218 | STERRAD CHEMICAL INDICATOR STRIP | JOJ | Substantially Equivalent | Advanced Sterilization Products | accessdata.fda.gov |
| March 4, 2011 | K092622 | STERRAD 100NX STERILIZER EXPRESS CYCLE | MLR | Substantially Equivalent | Advanced Sterilization Products | accessdata.fda.gov |
| February 25, 2011 | K092755 | STERRAAD 100NX EXPRESS CYCLE TEST PACK | FRC | Substantially Equivalent | Advanced Sterilization Products | accessdata.fda.gov |
| November 13, 2008 | K082392 | EVOTECH ENDOSCOPE CLEANER AND REPROCESSOR | FEB | Substantially Equivalent | Advanced Sterilization Products | accessdata.fda.gov |
| June 11, 2008 | K081427 | BROWNE OPA TEST STRIP | JOJ | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| December 18, 2007 | K071537 | STERRAD 100NX TEST PACK | FRC | Substantially Equivalent | Advanced Sterilization Products | accessdata.fda.gov |
| November 29, 2007 | K071385 | STERRAD 100NX STERILIZER | MLR | Substantially Equivalent | Advanced Sterilization Products | accessdata.fda.gov |
| May 12, 2005 | K042450 | STERRAD NX CHALLENGE PACK | FRC | Substantially Equivalent | Advanced Sterilization Products | accessdata.fda.gov |
| April 22, 2005 | K042116 | STERRAD NX STERILIZER | MLR | Substantially Equivalent | Advanced Sterilization Products | accessdata.fda.gov |
| April 4, 2005 | K032959 | CIDEX OPA CONCENTRATE | MED | Substantially Equivalent | Advanced Sterilization Products | accessdata.fda.gov |
| April 2, 2004 | K040742 | MODIFICATION TO STERRAD SEALSURE CHEMICAL INDICATOR TAPE | JOJ | Substantially Equivalent | Advanced Sterilization Products | accessdata.fda.gov |
| April 3, 2003 | K023290 | STERRAD 50 & STERRAD 100S STERILIZERS | FLF | Substantially Equivalent | Advanced Sterilization Products | accessdata.fda.gov |
| February 27, 2003 | K030004 | 0.55% ORTH-PHTHALALDEHYDE SOLUTION | MED | Substantially Equivalent | Advanced Sterilization Products | accessdata.fda.gov |
| August 28, 2002 | K013003 | APTIMAX INSTRUMENT TRAY, INSTRUMENT MAT AND INSTRUMENT HOLDER | FRG | Substantially Equivalent | Advanced Sterilization Products | accessdata.fda.gov |
| June 15, 2000 | K991999 | STERRAD 100S STERILIZER | MLR | Substantially Equivalent | Advanced Sterilization Products | accessdata.fda.gov |
| December 7, 1998 | K981054 | BROWNE GA INDICATOR FOR CIDEX PRODUCTS | JOJ | Substantially Equivalent | Albert Browne , Ltd. | accessdata.fda.gov |
| May 19, 1995 | K951295 | STERRAD STERILIZATION POUCH | KCT | Substantially Equivalent | Advanced Sterilization Products | accessdata.fda.gov |
| October 4, 1993 | K921910 | STERRAD CHEMICAL INDICATOR | JOJ | Substantially Equivalent | Johnson & Johnson Medical, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| January 9, 2017 | 76194 | Class II | Terminated | STERRAD NX Sterilization System, Product Code: 10033, 10033-002 | Advanced Sterilization Products (ASP) has identified that in a rare sequence of events following an external power outage, the system door interlock can be become disengaged during system reboot for a 20-second duration. | accessdata.fda.gov |
| September 27, 2016 | 75290 | Class II | Terminated | EVOTECH Endoscope Cleaner and Reprocessor System 208V, Product Code: 50004 The EVOTECH ECR Endoscope Cleaner and Reprocessor, a washer/disinfector, is indicated for use with high-level disinfectant CIDEX OPA Concentrate | Advanced Sterilization Products (ASP) is recalling the EVOTECH Endoscope Cleaner and Reprocessor System because the hose may come loose and cause a leak. | accessdata.fda.gov |
| August 10, 2015 | 71887 | Class II | Terminated | CIDEX OPA Solution, P/N 20390 for use as a high level disinfectant for reprocessing heat sensitive medical devices. | Advanced Sterilization Products (ASP) is reminding all CIDEX OPA Solution customers to follow the warnings and rinsing procedure in their current labelling around the criticality of proper rinsing of medical device following disinfection with CIDEX OPA according to the CIDEX OPA Solution IFU (Instruction For Use). | accessdata.fda.gov |
| July 27, 2015 | 71708 | Class II | Terminated | CIDEX Activated Dialdehyde Solution, 4 bottles/case, P/N: 2266 | Advanced Sterilization Products (ASP) is recalling the CIDEX Activated Dialdehyde Solution because it may lack the adequate data to support the entire 24-month shelf life. | accessdata.fda.gov |
| July 17, 2015 | 71642 | Class II | Terminated | Wall Chart for STERRAD 100NX System, P/N 10104. The STERRAD 100NX Sterilizer is designed for sterilization of both metal and nonmetal medical devices at low temperatures. | Advanced Sterilization PRoducts (ASP) is recalling the Wall Chart for STERRAD 100NX System because it incorrectly states "APTIMAX Instrument Trays can be enclosed in either polypropylene wrap or in Tyvek Pouches with STERRAD Chemical Indicators." | accessdata.fda.gov |
| May 11, 2015 | 71209 | Class II | Terminated | EVOTECH Endoscope Cleaner and Reprocessing System 208V, P/N 50004. The ASP EVOTECH ECR Endoscope Cleaner and Reprocessor is a washer/disinfector, which is indicated for use with high-level disinfectant CIDEX OPA Concentr | Advanced Sterilization Products (ASP) is recalling the EVOTECH Endoscope Cleaner and Reprocessor (ECR) because it may not detect an improper endoscope connection on two channels, and subsequently pass the cycle without cancellation if there is a disconnected scope. | accessdata.fda.gov |
| December 24, 2014 | 70216 | Class II | Terminated | Tyvek Pouch/Roll with STERRAD Chemical Indicator, P/N 12425 | Advanced Sterilization Products (ASP) is recalling the Tyvek Rolls with STERRAD Chemical Indicator because they were shipped to customers after its expiration date of May 18, 2013. | accessdata.fda.gov |
| November 4, 2014 | 69692 | Class II | Terminated | STERRAD 50, Product Code 10114. The STERRAD Cassettes are used on STERRAD Sterilization System which is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices. | Advanced Sterilization Products is recalling the STERRAD System cassettes because the the leak indicator on the STERRAD System cassettes packaging may not function properly after exposure to hydrogen peroxide. | accessdata.fda.gov |
| December 16, 2013 | 67043 | Class II | Terminated | STERRAD NX Sterilization System, Product Code: 10033 The STERRAD NX Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD NX process to inactivate microorganisms on a broad range of | Advanced Sterilization Products (ASP) is recalling the STERRAD NX, STERRAD 50, and STERRAD 100S Sterilization Systems because some healthcare workers detected odors or smells possibly emanating from STERRAD Systems. | accessdata.fda.gov |
| November 26, 2013 | 66981 | Class II | Terminated | STERRAD Cyclesure Biological Indicator (BI, Part No. 14324. Intended to be used as a standard method for frequent monitoring of the STERRAD Sterilization System cycles. | Advanced Sterilization Products (ASP) is recalling the STERRAD Cyclesure Biological Indicator (BI) because ASP has identified a microscopic intermittent and low frequency flaw in the outer vial of the STERRAD Cyclesure 24 Biological Indicator. | accessdata.fda.gov |
| November 11, 2013 | 66815 | Class II | Terminated | STERRAD 100NX, Product Code: 10104 The STERRAD Steri lization System is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices. | Advanced Sterilization Products (ASP) is recalling the STERRAD NX and STERRAD 100NX sterilization systems because ASP has determined that the bronchoscopes may contain a polyurethane material in the suction channel location that is not listed in the current claims for interior channels (lumens) for processing in STERRAD systems. | accessdata.fda.gov |
| October 18, 2013 | 66546 | Class II | Terminated | Sterrad 100NX, Product Code: 10104. Used to sterilize heat and moisture sensitive reusable medical devices. | Advanced Sterilization Products (ASP) is recalling the Sterrad 100NX Sterilizer some healthcare workers detected odors/smells emanating from the 100NX Sterilizers, and it may be related to normal breakdown of the oil used in the Sterrad 200 vacuum pumps. | accessdata.fda.gov |
| October 3, 2013 | 66502 | Class III | Terminated | STERITITE Containers: STERITITE Container Kit, 1/4 size, 3" high, product code: 13902; STERITITE Mini Mid Size, 3" high, product code: 13903; STERITITE Container Kit, 1/2 size, 4" high, product code: 13904; STERITITE Con | Advanced Sterilization Products (ASP) is recalling the SteriTite containers because they do not have consistent data to show that sterility assurance level of 10(-6) is achieved during the half-cycle test runs on new, unprocessed containers. | accessdata.fda.gov |
| September 18, 2013 | 66328 | Class II | Terminated | STERRAD 200 Sterilizer (Single Door), Part Number: 10201. STERRAD 200 Sterilizer (Double Door), Part Number: 10202. The STERRAD Sterilization System is a low temperature general purpose sterilizer used to sterilize heat | Advanced Sterilization Products (ASP) is recalling the STERRAD 200 Sterilization System because it may emit an odor or smell into the surrounding environment that is not typical to normal operating conditions. | accessdata.fda.gov |
| September 18, 2013 | 66317 | Class II | Terminated | STERRAD 100NX Cassettes The STERRAD Sterilization System is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices. | Advanced Sterilization Products (ASP) is recalling the three lots (13F049, 13F050, 13F051) STERRAD 100NX Cassettes because ASP has determined that the leak indicator on the cassettes is effective for only 12 months of the cassette's labeled 15-month shelf-life. | accessdata.fda.gov |
| July 25, 2013 | 65957 | Class II | Terminated | STERRAD 100NX Cassettes, Product Code: 10144 The STERRAD Sterilization System is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices. | The recall of the STERRAD 100NX Cassettes was initiated because Advanced Sterilization Products (ASP) does not have adequate data to support the effectiveness of the packaging's leak indicator for the entire duration of the STERRAD 100 NX System cassette's 15 month shelf life. | accessdata.fda.gov |
| April 22, 2013 | 64972 | Class II | Terminated | STERRAD CYCLESURE 24 Biological Indicator (BI) The STERRAD CYCLESURE 24 Biological Indicator (BI), is intended to be used as a standard method for frequent monitoring of the STERRAD Sterilization System cycles. | Advanced Sterilization Products is recalling certain lots of STERRAD CYCLESURE 24 Biological Indicator product because it may not have adequate data to support the entire duration of the labeled shelf-life. | accessdata.fda.gov |
| March 28, 2013 | 64781 | Class II | Terminated | EVOTECH Endoscope Cleaner and Reprocessor System, P/N 50004. Designed to automatically clean and high-level disinfect flexible, submersible video or fiber-optic endoscopes. | Advanced Sterilization Products (ASP) is recalling the EVOTECH Endoscope Cleaner and Reprocessor (ECR) because they have received reports of smoke emanating from the system due to a circuit board malfunction that may occur in the Channel Control Manifold sub-assembly. | accessdata.fda.gov |
| March 22, 2013 | 64700 | Class II | Terminated | EVOTECH Endoscope Cleaner & Reprocessor System, P/N 50004 Designed to automatically clean and high-level disinfect flexible, submersible video or fiber-optic endoscopes. | Advanced Sterilization Products (ASP) has determined that a limited number of EVOTECH ECRs manufactured between 2011 and 2012 did not receive sufficient High Potential (HIPOT) DC voltage testing. | accessdata.fda.gov |
| March 22, 2013 | 64692 | Class II | Terminated | STERRAD 100NX Sterilization System, P/N 10104 Product Usage: The STERRAD 100NX Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD 100NX process to inactivate microorganisms on a | The recall was initiated because Advanced Sterilization Products (ASP) has determined that the STERRAD 100NX and STERRAD 200 Sterilization Systems may emit an odor or smell into the surrounding environment that is not typical to normal operating conditions. | accessdata.fda.gov |
| October 3, 2012 | 63758 | Class II | Terminated | STERRAD CYCLESURE 24 Biological Indicator (BI) product, P/N 14324. Validation kits with Sterrad Cyclesure 24 BI products: Codes/Serial Numbers, Product Description: 14324 Sterrad Cyclesure 24 Biological Indicator. 14324- | Advanced Sterilization Products (ASP) is recalling all lots of Sterrad Cyclesure 24 Biological Indicator (BI) manufactured between February 2008 and December 2011 because it may not have adequate data to support the entire duration of the labeled shelf-life. | accessdata.fda.gov |
| September 20, 2012 | 63877 | Class II | Terminated | STERRAD NX Cassettes, P/N 10133. The STERRAD NX sterilizations systems are low-temperature general purpose sterilizers used to sterilize heat and moisture sensitive reusable medical devices. The sterilant used is hydroge | Advanced Sterilization Products is recalling three lots of STERRAD NX System Cassettes because it does not have adequate data to support the entire duration of the product's labeled shelf-life. | accessdata.fda.gov |
| June 28, 2012 | 33854 | Class II | Terminated | STERRAD Cyclesure Biological Indicator (BI), P/N 14324 are sold in cases, packaged as part of STERRAD System Validation kits and STERRAD test packs. The STERRAD CYCLESURE 24 Biological Indicator (BI), P/N 14324 is intend | Advanced Sterilization Products (ASP) is recalling certain lots of the STERRAD CYCLESURE 24 Biological Indicator (BI) product because it does not have adequate data to support the entire duration of the product's labeled shelf-life. | accessdata.fda.gov |
| June 19, 2012 | 62925 | Class III | Terminated | STERRAD 100S Cassette, Batch # 12A077. The STERRAD 100S and STERRAD NX sterilizations systems are low-temperature general purpose sterilizers used to sterilize heat and moisture sensitive reusable medical devices. The st | Advanced Sterilization Products (ASP) is recalling (removing) the Sterrad 100S and Sterrad NX System cassettes because the camera used to verify printing on the Sterrad System cassettes was inadvertently disabled. The STERRAD 100S and STERRAD NX System cases were shipped without verification of proper printing. | accessdata.fda.gov |
| June 1, 2012 | 62919 | Class II | Terminated | CIDEX OPA, High Level Disinfectant Solution, Glutaraldehyde-free (0.55% ortho-phthaladehyde) solution. The CIDEX OPA solution is intended for automated and manual cleaning and disinfection. | The recall was initiated because Advanced Sterilization Products has discovered instances of missing labels on bottles of CIDEX OPA Solution, Part # 20390 manufactured between May 2011 and April 2012. | accessdata.fda.gov |
| March 13, 2012 | 64609 | Class II | Terminated | STERRAD 200 System Carriage, P/N 10208. Used as a tool to expedite loading and unloading processed items from a STERRAD 200 sterilizer. | Advanced Sterilization Products (ASP) is recalling the STERRAD 200 System Carriage because it can potentially become dislodged when an excessive load is applied. | accessdata.fda.gov |
| February 17, 2012 | 61954 | Not yet classified | Terminated | Sterrad Cyclesure 24 Biological Indicator, P/N: 14324 The STERRAD CYCLESURE 24 Biological Indicator is intended to be used as a standard method for frequent monitoring of the STERRAD Sterilization System cycles. | The recall was initiated by Advanced Sterilization Products because they recently determined that certain lots of raw materials that were rejected during incoming inspection acceptance test were used for the manufacture of a specific lot range of Sterrad Cyclesure 24 Biological Indicator. | accessdata.fda.gov |
| January 23, 2012 | 60889 | Not yet classified | Terminated | STERRAD 200 Sterilizer, Hydrogen Peroxide Gas Plasma Sterilizer, Chemical Sterilizer. STERRAD 200; Product Usage: The STERRAD Sterilization System is a low-temperature general-purpose sterilizer used to sterilize heat an | ASP determined that an internal filter in the vacuum pump on the STERRAD 200 System is subject to wear over time. | accessdata.fda.gov |
| June 23, 2010 | 56367 | Not yet classified | Terminated | Tyvek Self-Seal Pouch with STERRAD Chemical Indicator 12332. Intended to be used to contain medical devices that are being terminally sterilized in STERRAD Sterilization Systems. | The recall was initiated after Advanced Sterilization Products (ASP) discovered a non-conforming lot. The misaligned perforations may have caused the seal to be incomplete on some of the pouches, creating a potential breach for pouches being used to store sterilized equipment on shelves. | accessdata.fda.gov |
| February 19, 2010 | 57281 | Not yet classified | Terminated | ASP Automatic Endoscope Reprocessor (AER), Product Code: 20300 & 20301 The AER is a machine designed to automatically wash and high-level disinfect flexible, submersible fiberoptic or video endoscopes. | The recall was initiated because Advanced Sterilization Products (ASP) received three customer reports of elevated temperature of the high-level disinfectant solution used in the ASP AER as a result of a possible temperature monitoring system malfunction. This recall communication advised consignees that if high-level disinfectants are exposed to elevated te | accessdata.fda.gov |
| June 23, 2009 | 52632 | Not yet classified | Terminated | Sterrad CycleSure Biological Indicator, Product Code 14324. The Sterrad CycleSure Biological Indicator is intended to be used as a standard method for frequent monitoring of the Sterrad Sterilizer cycles. | Biological Indicator indicating a positive result does not maintain yellow color for the entire incubation period and some indicators experience media evaporation prior to the end of the labeled maximum incubation time. | accessdata.fda.gov |
| March 9, 2009 | 51413 | Not yet classified | Terminated | STERRAD 50 Sterilization System Product Code 10050 The STERRAD Sterilization System is a low-temperature general-purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices. | ASP has identified a secondary, lower-occurring cause of oil mist within certain STERRAD NX Systems and STERRAD 50 Systems due to potentially defective oil fill plugs. | accessdata.fda.gov |
| January 12, 2009 | 52124 | Not yet classified | Terminated | Sterrad 50 Sterilizer, Product Code 10050. Low-temperature general-purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices. | 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. | accessdata.fda.gov |
| December 10, 2008 | 51146 | Not yet classified | Terminated | STERRAD NX Sterilizer Hydrogen Peroxide Gas Plasma Sterilizer Product Code 10133. The STERRAD Sterilization System is a low-temperature general-purpose sterilizer used to sterilize heat and moisture sensitive reusable me | Advanced Sterilization Products (ASP) has discovered a defect in the barcode labeling of the STERRAD NX System Cassettes 10133, Lot #08I032. This is the only lot number affected by this action. The barcodes for Lot #08I032 were printed improperly and are not capable of being read by the STERRAD unit. | accessdata.fda.gov |
| October 17, 2008 | 50073 | Not yet classified | Terminated | STERRAD 100S Sterilizer (Product Code 10101). The sterilizer includes software and hardware components. The STERRAD Sterilization System is a low-temperature, general purpose sterilizer used to sterilize heat and moistur | 1) Inability of the sterilizer to detect when an injection takes place without hydrogen peroxide being transferred to the vaporizer bowl. This situation can result in a cycle completion with the injection of insufficient hydrogen peroxide sterilant and 2) Inability of the sterilizer to detect an obstruction in the door travel path while the door is closing. | accessdata.fda.gov |
| October 7, 2008 | 50071 | Not yet classified | Terminated | STERRAD NX Sterilizer, Product Code 10033 Low temperature sterilizers that use hydrogen peroxide gas plasma to inactivate microorganisms on a broad range of medical and surgical instruments. | ASP has discovered a component defect in some of the UV lamp power supplies used in certain STERRAD NX Sterilizers. This defect can potentially cause the Hydrogen Peroxide Monitor to give inaccurate readings. | accessdata.fda.gov |
| September 11, 2008 | 49451 | Not yet classified | Terminated | ASP Automatic Endoscope Reprocessor, AER Plus Product Code 20300 and AER with printer Product Code 20301 The AER is a machine designed to automatically wash and high-level disinfect flexible, submersible fiberoptic or vi | Residual high-level disinfectant solution remaining in endoscopes that have been reprocessed in the ASP Automatic Endoscope Reprocessor. If high-level disinfectant, or other fluids, remains in the endoscope after reprocessing, contact with the mucous membranes may occur and result in chemical burns, irritation (chemical colitis), or other symptoms. | accessdata.fda.gov |
| February 25, 2008 | 47355 | Not yet classified | Terminated | STERRAD 100S Sterilization System, Product Code 10101 Used to sterilize heat and moisture sensitive reusable medical devices. | Oil mist filter fails allowing oil mist to be emitted into the vicinity of the sterilizer, which may result in the release of a mist, "haze," or "smoke." | accessdata.fda.gov |
| February 13, 2008 | 46906 | Not yet classified | Terminated | EvoTech Endoscope Cleaner & Reprocessor, Product Code 50004 Indicated for use with high level disinfectant CIDEX OPA Concentrate and an enzymatic detergent, CIDEZYME GI, to achieve cleaning and high level disinfection of | Cleaning cycles are being cancelled. Specific issues are: a) Water heater tank is rusting resulting in the in-line 0.2 micron filter prematurely clogging, b) Interface board malfunction resulting in a premature lid opening, and c) Minor fluid leaks within the system (commonly at the 0.2 micron filter attachment points). | accessdata.fda.gov |
| November 12, 2007 | 45851 | Not yet classified | Terminated | STERRAD 100S Sterilizer, Product Code: 10101, Advanced Sterilization Products, Irvine, CA | User Guide Update: based on user reports about contact with residual hydrogen peroxide from instruments, pouches and trays after sterilization and subsequent light colored residue on these devices after sterilization updated user guidance has been issued. | accessdata.fda.gov |
| November 12, 2007 | 45846 | Not yet classified | Terminated | STERRAD Sterilizers ( Models 100S, 50, 200) Compatible Medical Device Reference List for US Customers, Document Numbers 15-53229 & 15-53230; STERRAD NX Sterilizers Compatible Medical Device Reference List for NX Customer | Outdated Compatibility Lists: Recalling firm has decided to discontinue dissemination of Compatible Medical Device Reference Lists and instrument assessment activities | accessdata.fda.gov |
| September 16, 2005 | 33513 | Not yet classified | Terminated | Vaporizer Plate Vaporizer Plate Consumable accessory used with the STERRAD 100 and the STERRAD 100S | The STERRAD 100 and the STERRAD 100S vaporizer plates are prone to displacement allowing micro-droplets of H2O2 to contact the load. If the vaporizer plate is dislodged, there is an increased chance for operators to have contact with H2O2 resulting in transient burns during the removal of the load. | accessdata.fda.gov |
| March 16, 2005 | 31495 | Not yet classified | Terminated | Cidexplus Solution Test Strips | CIDEX test strips were found to pass solution below MEC. | accessdata.fda.gov |
| April 12, 2004 | 29903 | Not yet classified | Terminated | CIDEX OPA Solution, ortho-Phthalaldehyde Solution | Anaphylactic-like reactions were reported following repeated cystoscopy for bladder cancer patients where the scope had been reprocessed in CIDEX OPA Solution. | accessdata.fda.gov |
| December 17, 2003 | 28031 | Not yet classified | Terminated | Cidex Plus Test Strips | May not accurately detect minimum effective concentration (MEC) | accessdata.fda.gov |
| September 4, 2003 | 27676 | Not yet classified | Terminated | Gluteraldehyde Concentration Indicators ''Browne GA Indicator for CIDEX PLUS Products'' | Performance failure complaints. | accessdata.fda.gov |
| February 14, 2003 | 25725 | Not yet classified | Terminated | Cidex Solution Test Strips Browne GA Indicators for Cidex Solution Test Strips. | Test strips which are used for QC of sterilant solution fail prematurely due to ingress of moisture. | accessdata.fda.gov |
Compare with other makers
- All makers of Medical Device Data System
- All makers of Sterilizer, Chemical
- All makers of Table, Mechanical
- All makers of Indicator, Physical/Chemical Sterilization Process
- All makers of Wrap, Sterilization
- All makers of Indicator, Biological Sterilization Process
Updated January 29, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.