Advanced Sterilization Products
FDA Regulatory Profile
Advanced Sterilization Products appears in FDA public data with 36 recalls, 59 510(k) clearances, 6 FDA inspections, and 1 compliance action on record. Its most recent recall (Z-1197-2017, Class II) was initiated on January 9, 2017. Its most recent 510(k) clearance was granted on April 15, 2026.
Summary
- Total Recalls
- 36
- 510(k) Clearances
- 59
- Inspections
- 6
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1197-2017 | Class II | STERRAD NX Sterilization System, Product Code: 10033, 10033-002 | January 9, 2017 |
| Z-0965-2017 | Class II | EVOTECH Endoscope Cleaner and Reprocessor System 208V, Product Code: 50004 The EVOTECH ECR Endosc | September 27, 2016 |
| Z-2774-2015 | Class II | CIDEX OPA Solution, P/N 20390 for use as a high level disinfectant for reprocessing heat sensitive m | August 10, 2015 |
| Z-2459-2015 | Class II | CIDEX Activated Dialdehyde Solution, 4 bottles/case, P/N: 2266 | July 27, 2015 |
| Z-2375-2015 | Class II | Wall Chart for STERRAD 100NX System, P/N 10104. The STERRAD 100NX Sterilizer is designed for ster | July 17, 2015 |
| Z-1715-2015 | Class II | EVOTECH Endoscope Cleaner and Reprocessing System 220-230V, P/N 50004-002. The ASP EVOTECH ECR En | May 11, 2015 |
| Z-1714-2015 | Class II | EVOTECH Endoscope Cleaner and Reprocessing System 208V, P/N 50004. The ASP EVOTECH ECR Endoscope | May 11, 2015 |
| Z-1312-2015 | Class II | Tyvek Pouch/Roll with STERRAD Chemical Indicator, P/N 12425 | December 24, 2014 |
| Z-0846-2015 | Class II | STERRAD 100NX, Product Code 10144 The STERRAD Cassettes are used on STERRAD Sterilization System | November 4, 2014 |
| Z-0845-2015 | Class II | STERRAD NX, Product Code 10133 The STERRAD Cassettes are used on STERRAD Sterilization System whi | November 4, 2014 |
| Z-0843-2015 | Class II | STERRAD 100S, Product Code 10113. The STERRAD Cassettes are used on STERRAD Sterilization System | November 4, 2014 |
| Z-0844-2015 | Class II | STERRAD 200, Product Code 10118 The STERRAD Cassettes are used on STERRAD Sterilization System wh | November 4, 2014 |
| Z-0842-2015 | Class II | STERRAD 50, Product Code 10114. The STERRAD Cassettes are used on STERRAD Sterilization System wh | November 4, 2014 |
| Z-0746-2014 | Class II | STERRAD 100S Sterilization System, Product Code: 10101 The STERRAD 100S Sterilization System is a g | December 16, 2013 |
| Z-0744-2014 | Class II | STERRAD NX Sterilization System, Product Code: 10033 The STERRAD NX Sterilization System is a gen | December 16, 2013 |
| Z-0745-2014 | Class II | STERRAD 50 Sterilization System, Product Code: 10050 The STERRAD 50 Sterilization System is a gener | December 16, 2013 |
| Z-0604-2014 | Class II | STERRAD Cyclesure Biological Indicator (BI, Part No. 14324. Intended to be used as a standard met | November 26, 2013 |
| Z-0402-2014 | Class II | STERRAD 100NX, Product Code: 10104 The STERRAD Steri lization System is a low temperature general | November 11, 2013 |
| Z-0403-2014 | Class II | STERRAD NX, Product Code: 10033 The STERRAD Steri lization System is a low temperature general pu | November 11, 2013 |
| Z-0190-2014 | Class II | Sterrad 100NX, Product Code: 10104. Used to sterilize heat and moisture sensitive reusable medica | October 18, 2013 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K252843 | STERRAD 100NX Sterilization System with ALLClear Technology (10104) | April 15, 2026 |
| K250802 | STERRAD® 100NX Sterilizer with ALLClear Technology (10104) | April 14, 2025 |
| K234084 | STERRAD Chemical Indicator (CI) Strip (14100); STERRAD® SEALSURE® Chemical Indicator (CI) Tape (142 | July 5, 2024 |
| K234082 | STERRAD® 100NX Sterilizer with ALLClear Technology and ULTRA GI Cycle (10104); APTIMAX Instrument | July 5, 2024 |
| K220404 | STERRAD NX with ALLClear Technology | May 16, 2022 |
| K212174 | STERRAD 100NX Sterilizer with ALLClear Technology | October 9, 2021 |
| K163598 | Tyvek Self-Seal Pouches with STERRAD Chemical Indicator, Tyvek Rolls with STERRAD Chemical Indicator | July 31, 2017 |
| K162007 | STERRAD NX Sterilizer | February 16, 2017 |
| K160818 | STERRAD® NX Sterilizer with ALLClear Technology | September 27, 2016 |
| K160903 | STERRAD 100NX Sterilizer with ALLClearTM Technology | September 26, 2016 |
| K151725 | STERRAD NX Sterilizer, STERRAD 100NX Sterilizer | January 13, 2016 |
| K151971 | STERRAD CYCLESURE 24 Biological Indicator | October 29, 2015 |
| K142454 | STERRAD NX Sterilizer, STERRAD 100NX Sterilizer | April 3, 2015 |
| K140977 | EVOTECH ECR | December 22, 2014 |
| K141693 | Tyvek® Pouch/Roll with STERRAD® Chemical Indicator | December 19, 2014 |
| K130263 | STERRAD 50/100S/200 TEST PACK | March 28, 2014 |
| K123017 | STERRAD CYCLESURE 24 BIOLOGICAL INDICATOR MODEL 14324 | December 26, 2012 |
| K112087 | TYVEK SELF-SEAL POUCHES ,TYVEK HEAT-SEAL ROLLS | October 15, 2012 |
| K122044 | STERRAD(R) CYCLESURE(R) 24 BIOLOGICAL INDICATOR | October 4, 2012 |
| K111518 | STERRAD CHEMIAL INDICATOR STRIP MODEL 14100 | October 3, 2012 |