Steris Corporation

FDA Regulatory Profile

Summary

Total Recalls
109
510(k) Clearances
202
Inspections
29
Compliance Actions
1

Recent Recalls

NumberClassProductDate
Z-0910-2026Class IIAMSCO 7053HP Washer/Disinfector Model/Catalog Number: 7053HP Product Description: The AMSCO 70November 19, 2025
Z-0909-2026Class IIAMSCO 7052HP Washer/Disinfector Model/Catalog Number: 7052HP Product Description: The AMSCO 705November 19, 2025
Z-2177-2025Class IIDual Flat Panel Monitor (DFPM) accessories for HarmonyAIR A-Series Surgical Lighting SystemsJune 23, 2025
Z-2178-2025Class IIDual Flat Panel Monitor (DFPM) accessories for HarmonyAIR E-Series Surgical Lighting SystemsJune 23, 2025
Z-1361-2026Class IIBarco MNA with the HexaVue IP Integration System, Model/Catalog Number: MNA-6x0-HMay 23, 2025
Z-2537-2024Class IIHookup Model/Catalog Number: 2-8-540HAN Product Description: Hookups provide the interface betweJune 13, 2024
Z-2536-2024Class IIHookup Model/Catalog Number: 2-8-540 Product Description: Hookups provide the interface between June 13, 2024
Z-2539-2024Class IIHookup Model/Catalog Number: DSD-110-HU0163 Product Description: Hookups provide the interface bJune 13, 2024
Z-2538-2024Class IIHookup Model/Catalog Number: 2-8-540CAS Product Description: Hookups provide the interface betweJune 13, 2024
Z-0984-2024Class IIDual Articulating Headrest, Velcro P/N P141210813, REF BF753December 12, 2023
Z-0983-2024Class IIDual Articulating Headrest, Pad Ret P/N P141210805, REF BF754December 12, 2023
Z-0737-2024Class IIV. Mueller Universal Bandage Scissors Black Plastic Handles Heavy-Duty, Autoclavable, Overall LengthNovember 16, 2023
Z-0617-2024Class IIHookup Accessories used with MEDIVATORS ADVANTAGE PLUS and ADVANTAGE PLUS Pass Thru Automated EndosNovember 13, 2023
Z-1595-2023Class IIReliance Vision Multi-Chamber Washer/Disinfector, Reference Number FH83062April 10, 2023
Z-1476-2023Class IISteris Lighting and Visualization Systems, Sterile Light handle Cover LB44 -Sterilizable consumablMarch 17, 2023
Z-1475-2023Class IISteris Lighting and Visualization Systems, Sterile Light Handle Cover (LB53)- Surgical light handle March 17, 2023
Z-0780-2023Class IIVERIFY Steam Test Pack (20 Tests and 5 controls) Item Number: S3065 Intended for use in installaDecember 12, 2022
Z-0779-2023Class IIVERIFY Dual Species Self-Contained Biological Indicators, 100 per box Item Number: S3061 IntendeDecember 12, 2022
Z-0778-2023Class IIVERIFY Dual Species Self-Contained Biological Indicators, 50 per box Item Number: S3060 IntendedDecember 12, 2022
Z-0781-2023Class IIVERIFY Steam Test Pack (20 Tests and 20 controls) Item Number: S3069 Intended for use in installDecember 12, 2022

Recent 510(k) Clearances

K-NumberDeviceDate
K252680Celerity™ 20 HP Biological IndicatorSeptember 24, 2025
K251048Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118May 2, 2025
K243876VERIFY STEAM Integrating IndicatorApril 25, 2025
K250842PADLOCK CLIP EFTR Kit (00713229)April 18, 2025
K250044Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP BFebruary 6, 2025
K250061Celerity IncubatorFebruary 6, 2025
K243475Chemical Indicator for enspire CLCSPS (LCC015)December 4, 2024
K243433enspire 3000 Cleaning and Liquid Chemical Sterilant Processing SystemDecember 2, 2024
K243075Defendo Single Use Cleaning Adapter for Olympus Endoscopes (100322, 100323, 4000096, 4003269, 400328November 8, 2024
K242742DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900)October 11, 2024
K240274PADLOCK CLIP EFTR Kit (00713229)September 17, 2024
K240032Celerity Chemical Indicator for enspire 3000 CLCSPSApril 17, 2024
K240352Defendo Single Use Cleaning Adapter for Olympus EndoscopesMarch 6, 2024
K240098DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900)February 9, 2024
K233681ConFirm 20 Minute IncubatorDecember 15, 2023
K233682VERIFY SPORE TEST STRIP for S40 STERILANT CONCENTRATEDecember 15, 2023
K232914SYSTEM 1E Liquid Chemical Sterilant Processing System (P6500); SYSTEM 1 endo Liquid Chemical SterilaOctober 3, 2023
K232918enspire 300 Series Automated Endoscope ReprocessorOctober 3, 2023
K231746VERIFY Spore Test Strip for S40 Sterilant ConcentrateSeptember 11, 2023
K223476V-PRO maX 2 Low Temperature Sterilization SystemAugust 7, 2023