Advanced Sterilization Products

FDA Regulatory Profile

Summary

Total Recalls
36
510(k) Clearances
58
Inspections
6
Compliance Actions
1

Recent Recalls

NumberClassProductDate
Z-1197-2017Class IISTERRAD NX Sterilization System, Product Code: 10033, 10033-002January 9, 2017
Z-0965-2017Class IIEVOTECH Endoscope Cleaner and Reprocessor System 208V, Product Code: 50004 The EVOTECH ECR EndoscSeptember 27, 2016
Z-2774-2015Class IICIDEX OPA Solution, P/N 20390 for use as a high level disinfectant for reprocessing heat sensitive mAugust 10, 2015
Z-2459-2015Class IICIDEX Activated Dialdehyde Solution, 4 bottles/case, P/N: 2266July 27, 2015
Z-2375-2015Class IIWall Chart for STERRAD 100NX System, P/N 10104. The STERRAD 100NX Sterilizer is designed for sterJuly 17, 2015
Z-1715-2015Class IIEVOTECH Endoscope Cleaner and Reprocessing System 220-230V, P/N 50004-002. The ASP EVOTECH ECR EnMay 11, 2015
Z-1714-2015Class IIEVOTECH Endoscope Cleaner and Reprocessing System 208V, P/N 50004. The ASP EVOTECH ECR Endoscope May 11, 2015
Z-1312-2015Class IITyvek Pouch/Roll with STERRAD Chemical Indicator, P/N 12425December 24, 2014
Z-0845-2015Class IISTERRAD NX, Product Code 10133 The STERRAD Cassettes are used on STERRAD Sterilization System whiNovember 4, 2014
Z-0844-2015Class IISTERRAD 200, Product Code 10118 The STERRAD Cassettes are used on STERRAD Sterilization System whNovember 4, 2014
Z-0842-2015Class IISTERRAD 50, Product Code 10114. The STERRAD Cassettes are used on STERRAD Sterilization System whNovember 4, 2014
Z-0843-2015Class IISTERRAD 100S, Product Code 10113. The STERRAD Cassettes are used on STERRAD Sterilization System November 4, 2014
Z-0846-2015Class IISTERRAD 100NX, Product Code 10144 The STERRAD Cassettes are used on STERRAD Sterilization System November 4, 2014
Z-0745-2014Class IISTERRAD 50 Sterilization System, Product Code: 10050 The STERRAD 50 Sterilization System is a generDecember 16, 2013
Z-0746-2014Class IISTERRAD 100S Sterilization System, Product Code: 10101 The STERRAD 100S Sterilization System is a gDecember 16, 2013
Z-0744-2014Class IISTERRAD NX Sterilization System, Product Code: 10033 The STERRAD NX Sterilization System is a genDecember 16, 2013
Z-0604-2014Class IISTERRAD Cyclesure Biological Indicator (BI, Part No. 14324. Intended to be used as a standard metNovember 26, 2013
Z-0403-2014Class IISTERRAD NX, Product Code: 10033 The STERRAD Steri lization System is a low temperature general puNovember 11, 2013
Z-0402-2014Class IISTERRAD 100NX, Product Code: 10104 The STERRAD Steri lization System is a low temperature generalNovember 11, 2013
Z-0190-2014Class IISterrad 100NX, Product Code: 10104. Used to sterilize heat and moisture sensitive reusable medicaOctober 18, 2013

Recent 510(k) Clearances

K-NumberDeviceDate
K250802STERRAD® 100NX Sterilizer with ALLClear™ Technology (10104)April 14, 2025
K234082STERRAD® 100NX Sterilizer with ALLClear™ Technology and ULTRA GI™ Cycle (10104); APTIMAX™ InstrumentJuly 5, 2024
K234084STERRAD™ Chemical Indicator (CI) Strip (14100); STERRAD® SEALSURE® Chemical Indicator (CI) Tape (142July 5, 2024
K220404STERRAD NX with ALLClear TechnologyMay 16, 2022
K212174STERRAD 100NX Sterilizer with ALLClear TechnologyOctober 9, 2021
K163598Tyvek Self-Seal Pouches with STERRAD Chemical Indicator, Tyvek Rolls with STERRAD Chemical IndicatorJuly 31, 2017
K162007STERRAD NX SterilizerFebruary 16, 2017
K160818STERRAD® NX Sterilizer with ALLClear™ TechnologySeptember 27, 2016
K160903STERRAD 100NX Sterilizer with ALLClearTM TechnologySeptember 26, 2016
K151725STERRAD NX Sterilizer, STERRAD 100NX SterilizerJanuary 13, 2016
K151971STERRAD CYCLESURE 24 Biological IndicatorOctober 29, 2015
K142454STERRAD NX Sterilizer, STERRAD 100NX SterilizerApril 3, 2015
K140977EVOTECH ECRDecember 22, 2014
K141693Tyvek® Pouch/Roll with STERRAD® Chemical IndicatorDecember 19, 2014
K130263STERRAD 50/100S/200 TEST PACKMarch 28, 2014
K123017STERRAD CYCLESURE 24 BIOLOGICAL INDICATOR MODEL 14324December 26, 2012
K112087TYVEK SELF-SEAL POUCHES ,TYVEK HEAT-SEAL ROLLSOctober 15, 2012
K122044STERRAD(R) CYCLESURE(R) 24 BIOLOGICAL INDICATOROctober 4, 2012
K111519STERRAD SEALSURE CHEMICAL INDICATOR TAPE MODEL 14202October 3, 2012
K111518STERRAD CHEMIAL INDICATOR STRIP MODEL 14100October 3, 2012