STERIS Corporation
STERIS Corporation holds FDA 510(k) medical device clearances, first cleared 1997, most recent 2026, with 112 FDA device recalls on record.
Top product codes for STERIS Corporation
FDA recalls by STERIS Corporation
10 most recent of 112- Z-2449-2026 — HarmonyAIR A-Series Surgical Lighting System
- Z-2448-2026 — HarmonyAIR A-Series Surgical Lighting System
- Z-2450-2026 — ALYON Surgical Lighting System
- Z-0910-2026 — AMSCO 7053HP Washer/Disinfector Model/Catalog Number: 7053HP Product Description: The AMSCO 7053HP Washer/Disinfector is intended for use in the cleaning and intermediate-level disinfection of soiled reusable simple hard-surfaced rigid surgical instruments (such as forceps and clamps), utensils (such as bedpans, urinals, trays, bowl, basin and kidney dishes), rubber and plastic goods, theatre shoes and other similar and related articles found in healthcare facilities.
- Z-0909-2026 — AMSCO 7052HP Washer/Disinfector Model/Catalog Number: 7052HP Product Description: The AMSCO 7052HP Washer/Disinfector is intended for use in the cleaning and intermediate-level disinfection of soiled reusable simple hard-surfaced rigid surgical instruments (such as forceps and clamps), utensils (such as bedpans, urinals, trays, bowl, basin and kidney dishes), rubber and plastic goods, theatre shoes and other similar and related articles found in healthcare facilities.
- Z-2178-2025 — Dual Flat Panel Monitor (DFPM) accessories for HarmonyAIR E-Series Surgical Lighting Systems
- Z-2177-2025 — Dual Flat Panel Monitor (DFPM) accessories for HarmonyAIR A-Series Surgical Lighting Systems
- Z-1361-2026 — Barco MNA with the HexaVue IP Integration System, Model/Catalog Number: MNA-6x0-H
- Z-2538-2024 — Hookup Model/Catalog Number: 2-8-540CAS Product Description: Hookups provide the interface between an Advantage Plus" Automated Endoscope Reprocessor and Advantage Plus" Pass-Thru Automated Endoscope Reprocessor ( AER ) and endoscopes, which allow perfusion of liquids dispensed by the AER to contact and high-level disinfect the channels of flexible endoscopes.
- Z-2536-2024 — Hookup Model/Catalog Number: 2-8-540 Product Description: Hookups provide the interface between an Advantage Plus" Automated Endoscope Reprocessor and Advantage Plus" Pass-Thru Automated Endoscope Reprocessor ( AER ) and endoscopes, which allow perfusion of liquids dispensed by the AER to contact and high-level disinfect the channels of flexible endoscopes.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by STERIS Corporation
1–100 of 205- K261055 — AMSCO 700 Steam Sterilizer
- K251666 — SYSTEM 1E Liquid Chemical Sterilant Processing System, Model P6700 +1 more
- K260766 — Celerity 5 HP Biological Indicator (LCB052)
- K252680 — Celerity 20 HP Biological Indicator
- K251048 — Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118
- K243876 — VERIFY STEAM Integrating Indicator
- K250842 — PADLOCK CLIP EFTR Kit (00713229)
- K250044 — Celerity 5 HP Biological Indicator (LCB052) +3 more
- K250061 — Celerity Incubator
- K243475 — Chemical Indicator for enspire CLCSPS (LCC015)
- K243433 — enspire 3000 Cleaning and Liquid Chemical Sterilant Processing System
- K243075 — Defendo Single Use Cleaning Adapter for Olympus Endoscopes (100322, 100323, 4000096, 4003269, 4003280)
- K242742 — DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900)
- K240274 — PADLOCK CLIP EFTR Kit (00713229)
- K240032 — Celerity Chemical Indicator for enspire 3000 CLCSPS
- K240352 — Defendo Single Use Cleaning Adapter for Olympus Endoscopes
- K240098 — DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900)
- K233681 — ConFirm 20 Minute Incubator
- K233682 — VERIFY SPORE TEST STRIP for S40 STERILANT CONCENTRATE
- K232914 — SYSTEM 1E Liquid Chemical Sterilant Processing System (P6500) +2 more
- K232918 — enspire 300 Series Automated Endoscope Reprocessor
- K231746 — VERIFY Spore Test Strip for S40 Sterilant Concentrate
- K223476 — V-PRO maX 2 Low Temperature Sterilization System
- K231490 — Celerity 20 HP Biological Indicator; VERIFY V24 Self-Contained Biological Indicator
- K231500 — Vis-U-All Low Temperature Sterilization Pouches
- K231501 — PRO-LITE Sterilization Tray
- K231878 — Uretero1 Single-Use Digital Flexible Ureteroscope (standard deflection), PN UROSD101, Uretero1 Single-Use Digital Flexible Ureteroscope (reverse deflection), PN URORD101, Vision1 Imaging Console and Display System, PN VIS101
- K230560 — enspire 300 Series Automated Endoscope Reprocessor System
- K230558 — Revital-Ox PAA High Level Disinfectant Chemical Indicator
- K230930 — enspire 3000 Cleaning and Liquid Chemical Sterile Processing System
- K223715 — Celerity Incubator
- K223717 — Celerity 5 HP Biological Indicator; Celerity 5 HP Challenge Pack
- K230582 — SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900
- K223466 — Uretero1 Single-Use Digital Flexible Ureteroscope (standard deflection), PN UROSD101 +2 more
- K223369 — truFreeze Console, PN CC301 +6 more
- K222615 — SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900, S40 Sterilant Concentrate
- K222272 — truFreeze Console, PN CC301 +6 more
- K213881 — Celerity Incubator
- K220395 — EndoGator Endoscopy Irrigation Tubing
- K220361 — Reliance EPS Endoscope Processing System and Reliance DG Dry Germicide
- K213262 — CELERITY HP Chemical Indicator
- K211347 — Uretero1 Ureteroscope System
- K212424 — AMSCO 400 Small Steam Sterilizers, AMSCO 400 Medium Steam Sterilizers
- K212860 — SmartBand EMR Kit (SB-EMR-K, SB-EMR-K-12, SB-EMR-K-9.4), SmartBand EMR Pack (SB-EMR-P, SB-EMR-P-12, SB-EMR-P-9.4), SmartSnare EMR Hexagonal Snare (SS-230-1 or packaged with kit)
- K211607 — SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900, S40 Sterilant Concentrate
- K210342 — BioShield- ERCP Biopsy Valve, BioShield Irrigator - Extension Tubing, BioShield Irrigating Adaptor
- K211500 — AMSCO 600 Medium Steam Sterilizer
- K210737 — SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900, S40 Sterilant Concentrate
- K202104 — BioGuard EUS Air/Water and Suction Valves
- K202721 — Celerity 20 Steam Biological Indicator for IUSS
- K203199 — RAS 12 Rack / RAS 12 Long Rack, used in RAS Cycle of AMSCO 7052HP / 7053HP Single Chamber Washer-Disinfector
- K202583 — BioShield biopsy valve EUS - Linear
- K203061 — Amsco Evolution Medium Steam Sterilizer (Models HC-900 and HC-1200),Evolution Automated Loading and Unloading System (ALUS) +2 more
- K200446 — STERIS Patient Warming System
- K200126 — VERIFY Assert Self-Contained Biological Indicator
- K200989 — Reliance Endoscope Processing System
- K200577 — RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the AMSCO 7052HP/7053HP Single Chamber Washer/Disinfector
- K191715 — Endoscope Tip Protector - Sterile, Endoscope Tip Protector - Non-sterile
- K192929 — SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900
- K192722 — Padlock Clip defect closure system, Padlock Pro-Select defect closure device
- K191343 — SYSTEM 1 endo Liquid Chemical Sterilant Processing System,Model P6900
- K192020 — Celerity HP Chemical Indicator, Celerity Vaporized VH2O2 Process Indicator Adhesive Label, VERIFY V24 Self-Contained Biological Indicator Vial Label
- K190081 — RAS 12 Rack, RAS 12 Long Rack; RAS Cycle of AMSCO 7052HP/7053HP Single Chamber Washer/Disinfector
- K190297 — Celerity HP Incubator
- K190917 — V-PRO 60 a Low Tempurature Strilization Systems, V-PRO s2 Low Temperature Sterilization Systems
- K183428 — Avulsion Forceps
- K190103 — V-PRO maX 2 Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System, V-PRO 1 Plus Low Temperature Sterilization System, V-PRO 1 Low Temperature Sterilization System
- K183410 — AMSCO 600 Steam Sterilizer
- K183401 — Vis-U-All Low Temperature Sterilization Pouch/Tubing
- K183402 — PRO-LITE Sterilization Tray
- K182827 — SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model 6900
- K183293 — VERIFY VH202 Indicator Tape
- K182568 — V-PRO s2 Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization System
- K183294 — CELERITY 20 HP Biological Indicator, CELERITY HP Challenge Pack
- K183297 — Vis-U-All Low Temperature Sterilization Pouch/Tubing
- K183301 — PRO-LITE Sterilization Tray
- K181865 — Acu-sInQ Complete Endoscope Cleaning Aid System
- K182724 — CelerityTM 10 STEAM Chemical Indicator
- K181686 — CELERITY 20 Steam Biological Indicator
- K181429 — CELERITY 20 HP Biological Indicator
- K181442 — VERIFY Assert Self-Contained Biological Indicator
- K180553 — VERIFY Spore Test Strip for S40 Sterilant
- K180689 — Padlock Clip defect closure device; Padlock Clip Pro-Select defect closure device
- K173481 — Amsco Evolution Medium Steam Sterilizer
- K173256 — System 1 endo Liquid Chemical Sterilant Processing System
- K173428 — VERIFY Chemical Indicator for S40 Sterilant
- K173488 — CELERITY 20 HP Challenge Pack
- K173633 — VERIFY All-In-One STEAM Reusable Test Pack, VERIFY All-In-One STEAM Reusable Test Pack with Step Counter, VERIFY All-In-One STEAM Reusable Test Pack with Tracker Tag
- K173493 — Amsco Evolution Floorloader Steam Sterilizer HC-2000 and HC-3000
- K173485 — Amsco Evolution Medium Steam Sterilizer
- K173490 — Amsco Evolution Medium Steam Sterilizer (Models HC-800 and HC-1000)
- K173626 — Celerity 20 Steam Process Challenge Device for Dynamic Air Removal Cycles
- K173629 — CELERITY 20 Steam Process Challenge Device for Gravity Cycles
- K173634 — CELERITY 20 Steam Biological Indicator
- K173670 — CELERITY 20 Steam Incubator
- K172746 — VERIFY® HPU Chemical Indicator and VERIFY® Vaporized VH2O2 Process Indicator Adhesive Label
- K172749 — Vis-U-All Low Temperature Sterilization Pouch/Tubing
- K172752 — CELERITY 20 HP Biological Indicator
- K172753 — VERIFY VH2O2 Indicator Tape
- K172754 — V-PRO maX 2 Low Temperature Sterilization System
Data sourced from openFDA. This site is unofficial and independent of the FDA.