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Advanced Sterilization Products has 26 FDA enforcement events on this register (36 product records) between 2012 and 2017: 26 device; the busiest year was 2013 with 12.
0% of its events are Class I; the most common class is Class II (24). 0 events are listed as ongoing; the recalling firm's address is in CA.
Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.
Enforcement events
Initiated Product (first record) Type Class Records Status 9 Jan 2017 STERRAD NX Sterilization System, Product Code: 10033, 10033-002 Device Class II 1 Terminated 27 Sep 2016 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 Solution and an enzymatic detergent (CIDEZYME XTRA) to achieve cleaning and high level… Device Class II 1 Terminated 10 Aug 2015 CIDEX OPA Solution, P/N 20390 for use as a high level disinfectant for reprocessing heat sensitive medical devices. Device Class II 1 Terminated 27 Jul 2015 CIDEX Activated Dialdehyde Solution, 4 bottles/case, P/N: 2266 Device Class II 1 Terminated 17 Jul 2015 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. Device Class II 1 Terminated 11 May 2015 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 Concentrate and an enzymatic detergent (CIDEZYME Gl) to achieve cleaning and high level disinfection of… Device Class II 2 Terminated 24 Dec 2014 Tyvek Pouch/Roll with STERRAD Chemical Indicator, P/N 12425 Device Class II 1 Terminated 4 Nov 2014 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. Device Class II 5 Terminated 16 Dec 2013 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 medical devices and surgical instruments. Device Class II 3 Terminated 26 Nov 2013 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. Device Class II 1 Terminated 11 Nov 2013 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. Device Class II 2 Terminated 18 Oct 2013 Sterrad 100NX, Product Code: 10104. Used to sterilize heat and moisture sensitive reusable medical devices. Device Class II 1 Terminated 3 Oct 2013 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 Container Kit, 3/4 size, 4" high, product code: 13905; STERITITE Container Kit, Full size, 4" high,… Device Class III 1 Terminated 18 Sep 2013 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 and moisture sensitive reusable medical devices. Device Class II 1 Terminated 18 Sep 2013 STERRAD 100NX Cassettes The STERRAD Sterilization System is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices. Device Class II 1 Terminated 25 Jul 2013 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. Device Class II 1 Terminated 22 Apr 2013 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. Device Class II 1 Terminated 28 Mar 2013 EVOTECH Endoscope Cleaner and Reprocessor System, P/N 50004. Designed to automatically clean and high-level disinfect flexible, submersible video or fiber-optic endoscopes. Device Class II 1 Terminated 22 Mar 2013 EVOTECH Endoscope Cleaner & Reprocessor System, P/N 50004 Designed to automatically clean and high-level disinfect flexible, submersible video or fiber-optic endoscopes. Device Class II 1 Terminated 22 Mar 2013 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 board range of medical devices and surgical instruments. Device Class II 2 Terminated 3 Oct 2012 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. 14324-02 Sterrad Cyclesure 24 Biological Indicator. 10134 Sterrad 100NX Express Cycle Kit. 10135 Sterrad… Device Class II 1 Terminated 20 Sep 2012 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 hydrogen peroxide supplied in cassette form as a separate accessory. The STERRAD NX Cassettes are only… Device Class II 1 Terminated 28 Jun 2012 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 intended to be used as a standard method for frequent monitoring of the STERRAD Sterilization System… Device Class II 1 Terminated 19 Jun 2012 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 sterilant used is hydrogen peroxide supplied in cassette form as a separate accessory. The STERRAD… Device Class III 2 Terminated 1 Jun 2012 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. Device Class II 1 Terminated 13 Mar 2012 STERRAD 200 System Carriage, P/N 10208. Used as a tool to expedite loading and unloading processed items from a STERRAD 200 sterilizer. Device Class II 1 Terminated
By type and class Class I: 0% of this firm's events; 18% of all events on the register.
Events by year Enforcement events for Advanced Sterilization Products by year initiated. Questions and answers How many FDA recalls has Advanced Sterilization Products had? 26 enforcement events (36 product records) on this register, 2012–2017: 26 device.
Are any Advanced Sterilization Products recalls ongoing? 0 events are listed as ongoing in the current openFDA export.
What class are Advanced Sterilization Products recalls? 24 Class II, 2 Class III. 0% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.
Where does this data come from? openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.
Provenance Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology .