Sterilizer, Chemical
General Hospital · 21 CFR 880.6860
Recent MDR events
5,242 adverse event reports on file
- V-PROJul 27, 2026InjurySteris Mexico, S. De R.l. De C.v.3005899764-2026-00050
- V-PRO MAX STERILIZERJul 16, 2026MalfunctionSteris Mexico, S. De R.l. De C.v.3005899764-2026-00049
- V-PRO MAX 2 STERILIZERJul 10, 2026MalfunctionSteris Mexico, S. De R.l. De C.v.3005899764-2026-00046
- STERRAD 100S STERILIZERJun 24, 2026InjuryAdvanced Sterilization Products2084725-2026-00004
- V-PROJun 19, 2026MalfunctionSteris Mexico, S. De R.l. De C.v.3005899764-2026-00044
- V-PROJun 11, 2026MalfunctionSteris Mexico, S. De R.l. De C.v.3005899764-2026-00042
- VAPROXJun 4, 2026MalfunctionSteris Corporation3003950207-2026-00015
- AMSCO V-PROMay 28, 2026MalfunctionSteris Mexico, S. De R.l. De C.v.3005899764-2026-00041
- AMSCO V-PROMay 7, 2026MalfunctionSteris Mexico, S. De R.l. De C.v.3005899764-2026-00034
- V-PRO MAX STERILIZERMay 7, 2026MalfunctionSteris Mexico, S. De R.l. De C.v.3005899764-2026-00033
Event type breakdown
Recalls
46 recall events for this product code
- Steris CorporationTerminatedFeb 13, 2018
V-PRO 60 Low Temperature Sterilization System (UDI: 00724995152000)
Correction to update sterilizer software to prohibit the use of expired sterilant prior to the start of a sterilization cycle.
Z-0772-2018 · View FDA record ↗ - Advanced Sterilization ProductsTerminatedFeb 14, 2017
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.
Z-1197-2017 · View FDA record ↗ - Advanced Sterilization ProductsTerminatedAug 13, 2015
Wall Chart for STERRAD 100NX System, P/N 10104.
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."
Z-2375-2015 · View FDA record ↗ - Advanced Sterilization ProductsTerminatedDec 22, 2014
STERRAD 200, Product Code 10118
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.
Z-0844-2015 · View FDA record ↗ - Advanced Sterilization ProductsTerminatedDec 22, 2014
STERRAD NX, Product Code 10133
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.
Z-0845-2015 · View FDA record ↗ - Advanced Sterilization ProductsTerminatedDec 22, 2014
STERRAD 100NX, Product Code 10144
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.
Z-0846-2015 · View FDA record ↗ - Advanced Sterilization ProductsTerminatedJan 14, 2014
STERRAD NX Sterilization System, Product Code: 10033
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.
Z-0744-2014 · View FDA record ↗ - Steris CorporationTerminatedDec 31, 2013
SYSTEM 1E Liquid Chemical Sterilant Processing System, Distributed by STERIS Corporation, Mentor, OH
Customers indicated fluctuations in environmental conditions sites and gradual degradation/deformation of check valve o-rings following frequent contact with S40 sterilant use solution result in nuisance aborts.
Z-0616-2014 · View FDA record ↗ - Advanced Sterilization ProductsTerminatedNov 26, 2013
STERRAD 100NX, Product Code: 10104
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.
Z-0402-2014 · View FDA record ↗ - Advanced Sterilization ProductsTerminatedNov 26, 2013
STERRAD NX, Product Code: 10033
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.
Z-0403-2014 · View FDA record ↗
Registered firms
123 firms currently registered for this product code
Steris Corporation
Mentor, OH, US
Jabil Inc.
AUBURN HILLS, MI, US
Advanced Sterilization Products
Irvine, CA, US
Cbr Enterprise Limited
Hong Kong, HK
Asp Global Manufacturing Gmbh
SCHAFFHAUSEN, CH
Steris Mexico, S. De R.l. De C.v.
GUADALUPE Nuevo Leon, MX
Zimmer, Inc.
WARSAW, IN, US
Steris Corporation
Mentor, OH, US
Ad Supply Group Limited
London London, City of, GB
Zimmer Biomet Taiwan Co., Ltd.
Taipei, TW
Ideate Medical
Saint Louis, MO, US
510(k) clearances
47 clearances for this product code
- Advanced Sterilization Products, Inc.Apr 15, 2026
K252843 · STERRAD 100NX Sterilization System with ALLClear Technology (10104)
- Advanced Sterilization Products, Inc.Apr 14, 2025
K250802 · STERRAD® 100NX Sterilizer with ALLClear Technology (10104)
- Lowtem Co., Ltd.Sep 18, 2024
K231893 · LOWTEM Crystal 120
- Advanced Sterilization ProductsJul 5, 2024
K234082 · STERRAD® 100NX Sterilizer with ALLClear Technology and ULTRA GI Cycle (10104); APTIMAX Instrument Tray for ULTRA GI Cycle (011077)
- Ideate Medical, Inc.Jun 27, 2024
K233762 · SteroScope® Sterilization Technology System
- SterisOct 20, 2023
K233065 · V-PRO maX 2 Low Temperature Sterilization System
- STERIS CorporationAug 7, 2023
K223476 · V-PRO maX 2 Low Temperature Sterilization System
- Plasmapp Co,., Ltd.May 25, 2023
K231169 · STERLINK plus Sterilizer with STERLOAD Cassette, Tyvek Roll with CI for STERLINK Sterilizer, Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40)