Company · US
STERIS Corporation
FDA 510(k) clearances and medical device recalls filed under this name, 1997 to 2026. Name variants (Inc, Corp, punctuation) are merged.
228510(k) clearances (5 in 12 months)
152recalls (16 in 12 months)
105recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| FRG | Wrap, Sterilization | 51 |
| FRC | Indicator, Biological Sterilization Process | 46 |
| JOJ | Indicator, Physical/Chemical Sterilization Process | 45 |
| FLE | Sterilizer, Steam | 33 |
| MLR | Sterilizer, Chemical | 31 |
| MED | Sterilant, Medical Devices | 27 |
| FEB | Accessories, Cleaning, For Endoscope | 13 |
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | 11 |
| MEC | Disinfector, Medical Devices | 11 |
| NZA | Accessories, Germicide, Cleaning, For Endoscopes | 10 |
| FQO | Table, Operating-Room, Ac-Powered | 8 |
| FSY | Light, Surgical, Ceiling Mounted | 8 |
| ODC | Endoscope Channel Accessory | 7 |
| FTD | Lamp, Surgical | 6 |
| GDC | Table, Operating-Room, Electrical | 5 |
| NVE | Washer, Cleaner, Automated, Endoscope | 5 |
| OWP | Biological Sterilization Process Indicator With Recombinant-Dna Plasmid | 5 |
| FLG | Cleaner, Ultrasonic, Medical Instrument | 4 |
| LGZ | Warmer, Thermal, Infusion Fluid | 4 |
| OVY | Liquid Chemical Processing System | 4 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 2, 2026 | K261791 | MEDIVATORS ADVANTAGE NXT Automated Endoscope Reprocessor Steris | FEB |
| Jun 24, 2026 | K261055 | AMSCO 700 Steam Sterilizer STERIS Corporation | FLE |
| May 1, 2026 | DEN240075 | Prolystica Pass Thru Disinfectant Wipes Steris | SHM |
| Apr 8, 2026 | K260766 | Celerity 5 HP Biological Indicator (LCB052) STERIS Corporation | FRC |
| Apr 8, 2026 | K251666 | SYSTEM 1E Liquid Chemical Sterilant Processing System, Model P6700; SYSTEM 1 endo Liquid Chemical Sterilant Processing S STERIS Corporation | MED |
| Sep 24, 2025 | K252680 | Celerity 20 HP Biological Indicator STERIS Corporation | FRC |
| Jun 6, 2025 | K251452 | Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP Biological Indicator Steris | FRC |
| May 2, 2025 | K251048 | Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118 STERIS Corporation | JOJ |
| Apr 25, 2025 | K243876 | VERIFY STEAM Integrating Indicator STERIS Corporation | JOJ |
| Apr 18, 2025 | K250842 | PADLOCK CLIP EFTR Kit (00713229) STERIS Corporation | PKL |
| Apr 15, 2025 | K242773 | Electro Lube NXT Steris | GEI |
| Feb 6, 2025 | K250061 | Celerity Incubator STERIS Corporation | FRC |
| Feb 6, 2025 | K250044 | Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP Biological Indicator STERIS Corporation | FRC |
| Dec 4, 2024 | K243475 | Chemical Indicator for enspire CLCSPS (LCC015) STERIS Corporation | JOJ |
| Dec 2, 2024 | K243433 | enspire 3000 Cleaning and Liquid Chemical Sterilant Processing System STERIS Corporation | FEB |
| Nov 12, 2024 | DEN230085 | VERIFY RESI-TEST SLIDE-THRU Cleaning Process Protein (CPP) Indicator Steris | SDC |
| Nov 8, 2024 | K243075 | Defendo Single Use Cleaning Adapter for Olympus Endoscopes (100322, 100323, 4000096, 4003269, 4003280) STERIS Corporation | ODC |
| Oct 11, 2024 | K242742 | DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900) STERIS Corporation | ODC |
| Sep 17, 2024 | K240274 | PADLOCK CLIP EFTR Kit (00713229) STERIS Corporation | PKL |
| Aug 20, 2024 | K242189 | CELERITY HP Indicator Tape (PCC077) Steris | JOJ |
| Jun 11, 2024 | K241344 | MetriCide OPA Plus Solution Test Strip Steris | JOJ |
| May 31, 2024 | K241055 | Electro Lube NXT Steris | GEI |
| Apr 17, 2024 | K240032 | Celerity Chemical Indicator for enspire 3000 CLCSPS STERIS Corporation | JOJ |
| Apr 10, 2024 | K240760 | CELERITY HP Indicator Tape Steris | JOJ |
| Mar 8, 2024 | K232826 | Articulator Injection Needle (00711807), Articulator Injection Needle (00711810), Articulator Injection Needle - enteros Steris | FBK |
| Mar 6, 2024 | K240352 | Defendo Single Use Cleaning Adapter for Olympus Endoscopes STERIS Corporation | ODC |
| Feb 9, 2024 | K240098 | DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900) STERIS Corporation | ODC |
| Dec 15, 2023 | K233682 | VERIFY SPORE TEST STRIP for S40 STERILANT CONCENTRATE STERIS Corporation | OVY |
| Dec 15, 2023 | K233681 | ConFirm 20 Minute Incubator STERIS Corporation | FRC |
| Dec 8, 2023 | K233654 | VERIFY® Chemical Indicator for SYSTEM 1E® and SYSTEM 1® endo Liquid Chemical Sterilant Processing Systems Steris | JOJ |
| Oct 27, 2023 | K233187 | Celerity Vaporized VH2O2 Process Indicator Adhesive Label (PCC078) Steris | JOJ |
| Oct 20, 2023 | K233065 | V-PRO maX 2 Low Temperature Sterilization System Steris | MLR |
| Oct 20, 2023 | K232951 | BioShield Biopsy Valve (00711124); BioShield Biopsy Valve (00711125); BioShield Biopsy Valve (00711126); BioShield Biops Steris | ODC |
| Oct 3, 2023 | K232918 | enspire 300 Series Automated Endoscope Reprocessor STERIS Corporation | NZA |
| Oct 3, 2023 | K232914 | SYSTEM 1E Liquid Chemical Sterilant Processing System (P6500); SYSTEM 1 endo Liquid Chemical Sterilant Processing System STERIS Corporation | MED |
| Sep 13, 2023 | K232485 | AMSCO 600 Steam Sterilizer Steris | FLE |
| Sep 11, 2023 | K231746 | VERIFY Spore Test Strip for S40 Sterilant Concentrate STERIS Corporation | OVY |
| Aug 7, 2023 | K231501 | PRO-LITE Sterilization Tray STERIS Corporation | KCT |
| Aug 7, 2023 | K231500 | Vis-U-All Low Temperature Sterilization Pouches STERIS Corporation | FRG |
| Aug 7, 2023 | K231490 | Celerity 20 HP Biological Indicator; VERIFY V24 Self-Contained Biological Indicator STERIS Corporation | FRC |
| Aug 7, 2023 | K231488 | Celerity HP Chemical Indicator; Celerity HP Multivariable Chemical Indicator; VERIFY HPU Chemical Indicator; VERIFY V Steris | JOJ |
| Aug 7, 2023 | K223476 | V-PRO maX 2 Low Temperature Sterilization System STERIS Corporation | MLR |
| Jul 25, 2023 | K231878 | Uretero1 Single-Use Digital Flexible Ureteroscope (standard deflection), PN UROSD101, Uretero1 Single-Use Digital Flexib STERIS Corporation | FGB |
| Jul 21, 2023 | K230560 | enspire 300 Series Automated Endoscope Reprocessor System STERIS Corporation | NZA |
| Jul 17, 2023 | K230558 | Revital-Ox PAA High Level Disinfectant Chemical Indicator STERIS Corporation | JOJ |
| Jun 30, 2023 | K230930 | enspire 3000 Cleaning and Liquid Chemical Sterile Processing System STERIS Corporation | FEB |
| Jun 15, 2023 | K223717 | Celerity 5 HP Biological Indicator; Celerity 5 HP Challenge Pack STERIS Corporation | FRC |
| Jun 15, 2023 | K223715 | Celerity Incubator STERIS Corporation | FRC |
| Mar 28, 2023 | K230582 | SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900 STERIS Corporation | MED |
| Feb 17, 2023 | K223466 | Uretero1 Single-Use Digital Flexible Ureteroscope (standard deflection), PN UROSD101; Uretero1 Single-Use Digital Flexib STERIS Corporation | FGB |
Newest 50 of 228.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 14, 2026 | Steris Corporation RAPICIDE PA Part A High-Level Disinfectant, Model/Catalog Number: ML020117 Open, Classified |
FEB | K082988 |
| Oct 14, 2026 | Steris Corporation RAPICIDE PA Part A High-Level Disinfectant, Model/Catalog Number: ML020116 Open, Classified |
FEB | K082988 |
| Oct 14, 2026 | Steris Corporation RAPICIDE PA Part A High-Level Disinfectant, Model/Catalog Number: ML020115 Open, Classified |
FEB | K082988 |
| Oct 7, 2026 | Steris Corporation HexaVue Focus Integration System, a single, all-in-one system that handles operating room video routing, surgical video integration, and environmental control, Software Version: 2.0.18 Open, Classified |
FTA | None listed |
| Oct 2, 2026 | Steris Corporation VERIFY Biological Steam Test Pack
Model/Catalog Number: S3069 Open, Classified |
FRC | K854902 |
| Oct 2, 2026 | Steris Corporation VERIFY Biological Steam Test Pack
Model/Catalog Number: S3065 Open, Classified |
FRC | K854902 |
| Oct 2, 2026 | Steris Corporation VERIFY Dual Species Self-Contained Biological Indicator
Model/Catalog Number: S3061 Open, Classified |
FRC | K083665 |
| Oct 2, 2026 | Steris Corporation VERIFY Dual Species Self-Contained Biological Indicator
Model/Catalog Number: S3060 Open, Classified |
FRC | K083665 |
| Oct 2, 2026 | Steris Corporation VERIFY Biological/Integrator Challenge Pack
Model/Catalog Number: LCB007 Open, Classified |
FRC | K854902 |
| Oct 2, 2026 | Steris Corporation VERIFY Biological/Integrator Challenge Pack
Model/Catalog Number: LCB006 Open, Classified |
FRC | K854902 |
| Jun 15, 2026 | Steris Corporation ALYON Surgical Lighting System Open, Classified |
FSY | None listed |
| Jun 15, 2026 | Steris Corporation HarmonyAIR A-Series Surgical Lighting System Open, Classified |
FSY | None listed |
| Jun 15, 2026 | Steris Corporation HarmonyAIR A-Series Surgical Lighting System Open, Classified |
FSY | None listed |
| Feb 12, 2026 | Steris Corporation Barco MNA with the HexaVue IP Integration System, Model/Catalog Number: MNA-6x0-H Open, Classified |
KQM | None listed |
| Dec 11, 2025 | Steris Corporation 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 soil Open, Classified |
MEC | None listed |
| Dec 11, 2025 | Steris Corporation 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 soile Open, Classified |
MEC | None listed |
| Jul 25, 2025 | Steris Corporation Dual Flat Panel Monitor (DFPM) accessories for HarmonyAIR E-Series Surgical Lighting Systems Open, Classified |
FSY | None listed |
| Jul 25, 2025 | Steris Corporation Dual Flat Panel Monitor (DFPM) accessories for HarmonyAIR A-Series Surgical Lighting Systems Open, Classified |
FSY | None listed |
| Aug 8, 2024 | Steris Corporation Hookup
Model/Catalog Number: DSD-110-HU0163
Product Description: Hookups provide the interface between DSD Automated Endoscope Reprocessors ( AER ) and endoscopes, which allow perfusion of liquids di Open, Classified |
FEB | K092387 |
| Aug 8, 2024 | Steris Corporation 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 Open, Classified |
FEB | K102996 |
| Aug 8, 2024 | Steris Corporation Hookup
Model/Catalog Number: 2-8-540HAN
Product Description: Hookups provide the interface between an Advantage Plus" Automated Endoscope Reprocessor and Advantage Plus" Pass-Thru Automated Endoscope Open, Classified |
FEB | K102996 |
| Aug 8, 2024 | Steris Corporation 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 Re Open, Classified |
FEB | K102996 |
| Feb 5, 2024 | Steris Corporation Dual Articulating Headrest, Velcro P/N P141210813, REF BF753 Open, Classified |
HBM | None listed |
| Feb 5, 2024 | Steris Corporation Dual Articulating Headrest, Pad Ret P/N P141210805, REF BF754 Open, Classified |
HBM | None listed |
| Jan 17, 2024 | Steris Corporation V. Mueller Universal Bandage Scissors Black Plastic Handles Heavy-Duty, Autoclavable, Overall Length 7 (18 cm)- Intended to cut through tape and bandages
Model: SU2014-001 Open, Classified |
LRW | None listed |
| Dec 22, 2023 | Steris Corporation Hookup Accessories used with MEDIVATORS ADVANTAGE PLUS and
ADVANTAGE PLUS Pass Thru Automated Endoscope Reprocessors
Model # Model Description
2-8-001 HU ZERO CHANNEL NO LT
2-8-010 ASSY, HOOK-UP, OLY Open, Classified |
FEB | K082988 K102996 +1 |
| May 17, 2023 | Steris Corporation Reliance Vision Multi-Chamber Washer/Disinfector, Reference Number FH83062 Open, Classified |
MEC | None listed |
| Apr 28, 2023 | Steris Corporation Steris Lighting and Visualization Systems, Sterile Light handle Cover LB44 -Sterilizable consumables (disposable, single use) used to drape the lighthandle of STERIS surgical lighting systems for th Open, Classified |
FTA | None listed |
| Apr 28, 2023 | Steris Corporation Steris Lighting and Visualization Systems, Sterile Light Handle Cover (LB53)- Surgical light handle covers, including disposable surgical light handle covers are designed to fit over surgical light ha Open, Classified |
FTA | None listed |
| Jan 3, 2023 | Steris Corporation VERIFY Steam Test Pack (20 Tests and 20 controls)
Item Number: S3069
Intended for use in installation testing and routine monitoring of steam and ethylene oxide sterilization processes Open, Classified |
FRC | K083665 |
| Jan 3, 2023 | Steris Corporation VERIFY Steam Test Pack (20 Tests and 5 controls)
Item Number: S3065
Intended for use in installation testing and routine monitoring of steam and ethylene oxide sterilization processes Open, Classified |
FRC | K083665 |
| Jan 3, 2023 | Steris Corporation VERIFY Dual Species Self-Contained Biological Indicators, 100 per box
Item Number: S3061
Intended for use in installation testing and routine monitoring of steam and ethylene oxide sterilization proc Open, Classified |
FRC | K083665 |
| Jan 3, 2023 | Steris Corporation VERIFY Dual Species Self-Contained Biological Indicators, 50 per box
Item Number: S3060
Intended for use in installation testing and routine monitoring of steam and ethylene oxide sterilization proce Open, Classified |
FRC | K083665 |
| Nov 16, 2022 | Steris Corporation GI4000 Electrosurgical Unit - intended to deliver electrosurgical outputs to perform cutting and/or coagulation and coagulation with or without delivery of argon gas, in flexible endoscopic applicatio Terminated |
GEI | K192265 |
| Oct 12, 2022 | Steris Corporation Hu-Friedy K360 Scalpel Handle, 360 Degree Scalpel Handle, REF K360 Terminated |
GDZ | None listed |
| Apr 22, 2022 | Steris Corporation Reliance Synergy Washer/Disinfector Terminated |
MEC | None listed |
| Mar 22, 2022 | Steris Corporation Ultra Pure Non-Woven Sponges Non-Sterile 4-Ply 2,000 per case 10 sleeves of 200 4 in x 4 in / 10.2 cm x 10.2 cm
Model Number: ENC4100 Terminated |
EFQ | K984187 |
| Mar 22, 2022 | Steris Corporation Ultra Pure Non-Woven Sponges Non-Sterile 4-Ply 5,000 per case 25 sleeves of 200 2 in x 2 in / 5.1 cm x 5.1 cm
Model Number: ENC100 Terminated |
EFQ | K984187 |
| Jan 21, 2021 | Steris Corporation OT1000 Series Orthopedic Surgical Tables Terminated |
JEA | None listed |
| Dec 11, 2020 | Steris Corporation Reliance Vision Single-Chamber Washer/Disinfector - Product Usage: intended for use in the cleaning and intermediate level disinfection of soiled reusable utensils, trays, glassware, bedpans and urina Terminated |
MEC | None listed |
| Dec 2, 2020 | Steris Corporation Vis-U-All High Temp 8"x16" Self Seal Pouch 200 pouches per box; 4 boxes per case
Model Number: 884816 Terminated |
FRG | K153540 |
| Dec 2, 2020 | Steris Corporation Vis-U-All High Temp 7.5"x13" Self Seal Pouch 200 pouches per box; 4 boxes per case
Model Number: 884713 Terminated |
FRG | K153540 |
| Dec 2, 2020 | Steris Corporation Vis-U-All High Temp 5"x15" Self Seal Pouch 200 pouches per box; 4 boxes per case
Model Number: 884515 Terminated |
FRG | K153540 |
| Dec 2, 2020 | Steris Corporation Vis-U-All High Temp 5.5"x10" Self Seal Pouch 200 pouches per box; 4 boxes per case
Model Number: 884510 Terminated |
FRG | K153540 |
| Dec 2, 2020 | Steris Corporation Vis-U-All High Temp 4"x11" Self Seal Pouch 200 pouches per box; 4 boxes per case
Model Number: 884411 Terminated |
FRG | K153540 |
| Dec 2, 2020 | Steris Corporation Vis-U-All High Temp 13"x18" Self Seal Pouch 100 pouches per box; 4 boxes per case
Model Number: 884118 Terminated |
FRG | K153540 |
| Dec 2, 2020 | Steris Corporation Vis-U-All High Temp 3.5"x9" Self Seal Pouch 200 pouches per box; 4 boxes per case
Model Number: 884039 Terminated |
FRG | K153540 |
| Dec 2, 2020 | Steris Corporation Vis-U-All High Temp 7.5"x13.5" Heat Seal Pouch 200 pouches per box; 5 boxes per case
Model Number: 883713 Terminated |
FRG | K153540 |
| Dec 2, 2020 | Steris Corporation Vis-U-All High Temp 6"x10" Heat Seal Pouch 200 pouches per box; 5 boxes per case
Model Number: 883610 Terminated |
FRG | K153540 |
| Dec 2, 2020 | Steris Corporation Vis-U-All High Temp 4.5"x11" Heat Seal Pouch 200 pouches per box; 5 boxes per case
Model Number: 883411 Terminated |
FRG | K153540 |
Newest 50 of 152.