Is this your brand? Sign in to claim ownership.

Advanced Sterilization Products, Inc.

United States·US-MF-000008427

Last updated September 18, 2026

About

Discover advanced sterilization solutions for medical devices with ASP, your trusted partner in infection prevention and control.

From the manufacturer's own website. Source

Information

Country: United States
Address: 33 Technology Drive, Irvine, CA, United States
Website: ASP.com
LinkedIn: linkedin.com/company/advancedsterilizationproducts
Facebook: facebook.com/Advanced-Sterilization-Products-107502634233297
Email: [email protected]
Phone: 18887837723 (from company website)
PRRC Contact: Brent Lewis
EUDAMED SRN: US-MF-000008427
FDA FEI Number: —
DUNS Number: —

Catalogue (303)

Page 1 of 7

Device	Model / Reference	Registries	Class	Status
CIDEZYME™ Enzymatic Detergent 1L	2258	EUDAMED	Class I	Active
CIDEX™ OPA Chemical Disinfectant Solution	20391	EUDAMED	Class IIb	Active
STERRAD™ Adaptor III	15403	EUDAMED	Class IIa	Active
CIDEZYME™ Enzymatic Detergent 5L	2260	EUDAMED	Class I	Active
CIDEX™ Instrument Tray System 489 mm x 718 mm x 222 mm	82032	EUDAMED	Class I	Active
CIDEZYME BIOCLEAN™ Enzymatic Detergent	88301	EUDAMED	Class I	Active
STERRAD™ Adaptor IV	15407	EUDAMED	Class IIa	Active
STERRAD™ Adaptor I	15401	EUDAMED	Class IIa	Active
CIDEX™ Instrument Tray System 220 mm x 740 mm x 136 mm	82027	EUDAMED	Class I	Active
STERRAD™ Adaptor II	15402	EUDAMED	Class IIa	Active
STERRAD™ Booster	15400-020	EUDAMED	Class IIa	Active
CIDEX™ Instrument Tray System 186 mm x 503 mm x 132 mm	82016	EUDAMED	Class I	Active
Evotech	907501	FDA UDI	Class II	Active
Aptimax	13839	FDA UDI	Class II	Active
Evotech	102501	FDA UDI	Class II	Active
STERRAD 100NX with ALLCLEAR Technology And ULTRA GI cyle	10104-010	EUDAMEDFDA UDI	Class II	Active
Evotech	849101	FDA UDI	Class II	Active
Evotech	945701	FDA UDI	Class II	Active
Evotech	849301	FDA UDI	Class II	Active
Evotech	103201	FDA UDI	Class II	Active
Sterrad	20229	FDA UDI	N/A	Active
Sterrad	10104	FDA UDI	Class II	Active
Sterrad	99403	FDA UDI	Class I	Active
Evotech	101701	FDA UDI	Class II	Active
Evotech	101501	FDA UDI	Class II	Active
Sterrad	99206	FDA UDI	Class I	Active
Tyvek Roll	12450	EUDAMEDFDA UDI	Class II	Active
Sterrad	10113	EUDAMEDFDA UDI	Class II	Active
Evotech	114701	FDA UDI	Class II	Active
Tyvek Self Seal Pouch	12342	EUDAMEDFDA UDI	Class II	Active
Evotech	941201	FDA UDI	Class II	Active
Sterrad	21005	FDA UDI	Class I	Active
Evotech	9414001	FDA UDI	Class II	Active
Sterrad	10104-004	FDA UDI	Class II	Active
Evotech	910601	FDA UDI	Class II	Active
Asp Aeroflex	9119012	FDA UDI	Class II	Active
Sterrad	20239	FDA UDI	Class II	Unknown
Evotech	117001	FDA UDI	Class II	Active
Evotech	104101	FDA UDI	Class II	Unknown
Evotech	849201	FDA UDI	Class II	Active
Evotech	904001	FDA UDI	Class II	Active
Sterrad	99404	FDA UDI	Class I	Active
Evotech	102001	FDA UDI	Class II	Active
Asp Aeroflex	9119013	FDA UDI	Class II	Active
Sterrad	20250	FDA UDI	N/A	Active
Evotech	51112	FDA UDI	Class II	Active
Cidex	20393	EUDAMEDFDA UDI	Class II	Active
Evotech	117501	FDA UDI	Class II	Active
Evotech	105601	FDA UDI	Class II	Active
Evotech	105401	FDA UDI	Class II	Active

Related Companies

Authorised Representatives

ASP, The Netherlands B.V. NL

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (69)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Jan 9, 2017	Z-1197-2017	—	terminated	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.
Sep 27, 2016	Z-0965-2017	—	terminated	Advanced Sterilization Products (ASP) is recalling the EVOTECH Endoscope Cleaner and Reprocessor System because the hose may come loose and cause a leak.
Aug 10, 2015	Z-2774-2015	—	terminated	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).
Jul 27, 2015	Z-2459-2015	—	terminated	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.
Jul 17, 2015	Z-2375-2015	—	terminated	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."
May 11, 2015	Z-1714-2015	—	terminated	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.
May 11, 2015	Z-1715-2015	—	terminated	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.
Dec 24, 2014	Z-1312-2015	—	terminated	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.
Nov 4, 2014	Z-0842-2015	—	terminated	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.
Nov 4, 2014	Z-0845-2015	—	terminated	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.
Nov 4, 2014	Z-0844-2015	—	terminated	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.
Nov 4, 2014	Z-0846-2015	—	terminated	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.
Nov 4, 2014	Z-0843-2015	—	terminated	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.
Dec 16, 2013	Z-0746-2014	—	terminated	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.
Dec 16, 2013	Z-0745-2014	—	terminated	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.
Dec 16, 2013	Z-0744-2014	—	terminated	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.
Nov 26, 2013	Z-0604-2014	—	terminated	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.
Nov 11, 2013	Z-0403-2014	—	terminated	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.
Nov 11, 2013	Z-0402-2014	—	terminated	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.
Oct 18, 2013	Z-0190-2014	—	terminated	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.
Oct 3, 2013	Z-0434-2014	—	terminated	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.
Sep 18, 2013	Z-0043-2014	—	terminated	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.
Sep 18, 2013	Z-0044-2014	—	terminated	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.
Jul 25, 2013	Z-2174-2013	—	terminated	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.
Apr 22, 2013	Z-1180-2013	—	terminated	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.
Mar 28, 2013	Z-1150-2013	—	terminated	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.
Mar 22, 2013	Z-1123-2013	—	terminated	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.
Mar 22, 2013	Z-1027-2013	—	terminated	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.
Mar 22, 2013	Z-1026-2013	—	terminated	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.
Oct 3, 2012	Z-0520-2013	—	terminated	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.
Sep 20, 2012	Z-0661-2013	—	terminated	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.
Jun 28, 2012	Z-2100-2012	—	terminated	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.
Jun 19, 2012	Z-2337-2012	—	terminated	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.
Jun 19, 2012	Z-2338-2012	—	terminated	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.
Jun 1, 2012	Z-2276-2012	—	terminated	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.
Mar 13, 2012	Z-0998-2013	—	terminated	Advanced Sterilization Products (ASP) is recalling the STERRAD 200 System Carriage because it can potentially become dislodged when an excessive load is applied.
Feb 17, 2012	Z-1773-2012	—	terminated	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.
Jan 23, 2012	Z-0741-2012	—	terminated	ASP determined that an internal filter in the vacuum pump on the STERRAD 200 System is subject to wear over time.
Jun 23, 2010	Z-1393-2011	—	terminated	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.
Feb 19, 2010	Z-0628-2011	—	terminated	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 temperatures, fumes may occur and resul
Jun 23, 2009	Z-0066-2010	—	terminated	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.
Mar 9, 2009	Z-1420-2009	—	terminated	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.
Mar 9, 2009	Z-1419-2009	—	terminated	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.
Jan 12, 2009	Z-1570-2009	—	terminated	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.
Dec 10, 2008	Z-0468-2012	—	terminated	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.
Oct 17, 2008	Z-0340-2009	—	terminated	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. This situation can result in a hand b
Oct 7, 2008	Z-0484-2009	—	terminated	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.
Sep 11, 2008	Z-0281-2009	—	terminated	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.
Feb 25, 2008	Z-1631-2008	—	terminated	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."
Feb 25, 2008	Z-1630-2008	—	terminated	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."
Feb 25, 2008	Z-1629-2008	—	terminated	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."
Feb 25, 2008	Z-1632-2008	—	terminated	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."
Feb 25, 2008	Z-1628-2008	—	terminated	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."
Feb 13, 2008	Z-1369-2008	—	terminated	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).
Feb 13, 2008	Z-1368-2008	—	terminated	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).
Nov 12, 2007	Z-0846-2008	—	terminated	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.
Nov 12, 2007	Z-0845-2008	—	terminated	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.
Nov 12, 2007	Z-0844-2008	—	terminated	Outdated Compatibility Lists: Recalling firm has decided to discontinue dissemination of Compatible Medical Device Reference Lists and instrument assessment activities
Nov 12, 2007	Z-0848-2008	—	terminated	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.
Nov 12, 2007	Z-0847-2008	—	terminated	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.
Sep 16, 2005	Z-0197-06	—	terminated	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.
Mar 16, 2005	Z-0779-05	—	terminated	CIDEX test strips were found to pass solution below MEC.
Apr 12, 2004	Z-0051-05	—	terminated	Anaphylactic-like reactions were reported following repeated cystoscopy for bladder cancer patients where the scope had been reprocessed in CIDEX OPA Solution.
Dec 17, 2003	Z-0375-04	—	terminated	May not accurately detect minimum effective concentration (MEC)
Sep 4, 2003	Z-1479-04	—	terminated	Performance failure complaints.
Sep 4, 2003	Z-1480-04	—	terminated	Performance failure complaints.
Sep 4, 2003	Z-1481-04	—	terminated	Performance failure complaints.
Feb 14, 2003	Z-0694-03	—	terminated	Test strips which are used for QC of sterilant solution fail prematurely due to ingress of moisture.
Feb 14, 2003	Z-0695-03	—	terminated	Test strips which are used for QC of sterilant solution fail due to ingress of moisture.