Data / Medical devices / United States / Steris Corporation
Steris Corporation: FDA-registered device maker in Mentor, OH, United States, 41 510(k) clearances
Steris Corporation is registered with the FDA (registration 1527821) in Mentor, OH, United States. It lists 4 device types. The FDA files 41 510(k) clearances under its listings, the newest dated April 8, 2026. 84 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 1527821
- Address
- 5960 Heisley Road, Mentor, OH, United States, 44060
- Owner or operator
- STERIS Corporation (10078069)
- Roles
- Specification developer
- First device listed
- October 13, 2020
- Registered through
- 2027
- Brand names listed
- AMSCO V-PRO 1 Low Temperature Sterilization System (MY-CFE), AMSCO V-PRO 1 PLUS Low Temperature Sterilization System (MY-CFE), AMSCO V-PRO 1 Plus Low Temperature Sterilization System (MY-CFE), AMSCO V-PRO maX Low Temperature Sterilization System (MY-CFE), Amsco V-PRO 1 Low Temperature Sterilization System (MY-CFE), Amsco V-PRO 1 Low Temperature Sterilization Systems (MY-CFE), Amsco V-PRO 1 Plus Low Temperature Sterilization System (MY-CFE), Minncare HD and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessories, Cleaning, For Endoscope | FEB | 2 | Specification developer | accessdata.fda.gov |
| Disinfectant, Subsystem, Water Purification | NIH | 2 | Specification developer | accessdata.fda.gov |
| Sterilant, Medical Devices | MED | 2 | Specification developer | accessdata.fda.gov |
| Sterilizer, Chemical | MLR | 2 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 8, 2026 | K251666 | SYSTEM 1E Liquid Chemical Sterilant Processing System, Model P6700; SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900 | MED | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| December 2, 2024 | K243433 | enspire 3000 Cleaning and Liquid Chemical Sterilant Processing System | FEB | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| October 20, 2023 | K233065 | V-PRO maX 2 Low Temperature Sterilization System | MLR | Substantially Equivalent | Steris | accessdata.fda.gov |
| October 3, 2023 | K232914 | SYSTEM 1E Liquid Chemical Sterilant Processing System (P6500); SYSTEM 1 endo Liquid Chemical Sterilant Processing System (P6800); SYSTEM 1 endo Liquid Chemical Sterilant Processing System (P6900) | MED | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| June 30, 2023 | K230930 | enspire 3000 Cleaning and Liquid Chemical Sterile Processing System | FEB | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| March 28, 2023 | K230582 | SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900 | MED | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| September 28, 2022 | 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 | MED | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| September 9, 2022 | K222093 | V-PRO maX 2 Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System | MLR | Substantially Equivalent | Steris | accessdata.fda.gov |
| September 7, 2021 | 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 | MED | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| May 12, 2021 | 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 | MED | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| December 10, 2019 | 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 | MED | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| September 5, 2019 | K191343 | SYSTEM 1 endo Liquid Chemical Sterilant Processing System,Model P6900 | MED | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| May 9, 2019 | K190917 | V-PRO 60 a Low Tempurature Strilization Systems, V-PRO s2 Low Temperature Sterilization Systems | MLR | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| April 5, 2019 | 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 | MLR | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| March 22, 2019 | K190104 | SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 Endo Liquid Chemical Sterilant Processing System | MED | Substantially Equivalent | Steris Corporations | accessdata.fda.gov |
| January 31, 2019 | K182827 | SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model 6900 | MED | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| January 3, 2019 | K182568 | V-PRO s2 Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization System | MLR | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| April 4, 2018 | K180342 | SYSTEM 1E Liquid Chemical Sterilant Processing System | MED | Substantially Equivalent | Steris Corporations | accessdata.fda.gov |
| March 2, 2018 | K173256 | System 1 endo Liquid Chemical Sterilant Processing System | MED | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| February 9, 2018 | K172754 | V-PRO maX 2 Low Temperature Sterilization System | MLR | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| January 18, 2018 | K172319 | AMSCO V-PRO 1 Low Temperature Sterilization System, AMSCO V-PRO 1 Plus Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization System | MLR | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| September 22, 2017 | K170956 | SYSTEM 1E Liquid Chemical Sterilant Processing System | MED | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| March 31, 2017 | K162413 | AMSCO V-PRO 1 Low Temperature Sterilization System, AMSCO V-PRO 1 Plus Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization System | MLR | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| August 5, 2016 | K161683 | SYSTEM 1E Liquid Chemical Sterilant Processing System | MED | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| July 6, 2016 | K160433 | V-PRO® 1 Plus and V-PRO® maX Low Temperature | MLR | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| August 27, 2014 | K133724 | MINNCARE HD | NIH | Substantially Equivalent | Medivators, Inc. | accessdata.fda.gov |
| July 24, 2014 | K140498 | V-PRO 60 LOW TEMPERATURE STERILIZATION SYSTEM | MLR | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| July 16, 2013 | K131120 | AMSCO V-PRO 1 LOW, V-PRO 1 PLUS, V-PRO MAX LOW TEMPERATURE STERILIZATION SYSTEM | MLR | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| July 5, 2013 | K131078 | SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM | MED | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| June 26, 2012 | K120632 | AMSCO V-PRO 1 LOW/PLUS/MAX TEMPERATURE STERILIZATION SYSTEM | MLR | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| February 21, 2012 | K113520 | SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM | MED | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| December 1, 2011 | K112813 | AMSCO V-PRO | MLR | Substantially Equivalent | Steris Corp | accessdata.fda.gov |
| November 22, 2011 | K112760 | AMSCO V-PRO MAX LOW TEMPERATURE STERILIZATION SYSTEM | MLR | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| September 2, 2011 | K111810 | AMSCO V-PRO 1 AND V-PRO 1 PLUS LOW TEMPERATURE STERILIZATION UNITS | MLR | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| August 18, 2011 | K102394 | AMSCO V-PRO 1 LOW TEMPERATURE STERILIZATION SYSTEM; AMSCO V-PRO 1 PLUS LOW TEMPERATURE STERILIZATION SYSTEM | MLR | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| August 12, 2011 | K102330 | AMSCO V-PRO MAX LOW TEMPERATURE STERILIZATION SYSTEM | MLR | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| September 21, 2010 | K102462 | SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM | MED | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| August 2, 2010 | K101409 | SYSTEM IE LIQUID CHEMICAL CTERILANT PROCESSING SYSTEM | MED | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| April 5, 2010 | K090036 | SYSTEM 1.5 STERILE PROCESSING SYSTEM | MED | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| August 3, 2009 | K083097 | AMSCO V-PRO 1 LOW TEMPERATURE STERILIZATION SYSTEM | MLR | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| October 4, 2007 | K062297 | VHP 136 LOW TEMPERATURE STERILIZATION SYSTEM | MLR | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| September 23, 2026 | 99856 | Class II | Ongoing | 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 | A software issue may result in unintended mismatch of patient information on manually printed images. Incorrect patient information appearing on printed images could create a documentation discrepancy or incorrect association of clinical images with a patient record. | accessdata.fda.gov |
| September 21, 2026 | 99804 | Class II | Ongoing | RAPICIDE PA Part A High-Level Disinfectant, Model/Catalog Number: ML020115 | If the vented cap becomes blocked, gas may accumulate and the bottle may swell due to increased internal pressure. In some cases, excess vapor or liquid chemistry may escape from the bottle when the cap is twisted during opening, which could result in user exposure if required personal protective equipment (PPE) is not properly used. Such exposure may result | accessdata.fda.gov |
| August 31, 2026 | 99704 | Class II | Ongoing | VERIFY Biological/Integrator Challenge Pack Model/Catalog Number: LCB006 | Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization cycles, the potential hazard is that the biological indicator will show no growth, indicating that the steam cycle was effective, even if the steam cycle did not achieve the intended spore reduction | accessdata.fda.gov |
| May 15, 2026 | 98768 | Class II | Ongoing | HarmonyAIR A-Series Surgical Lighting System | The the plus and minus buttons (+/-) used to control light intensity on the light heads may detach. | accessdata.fda.gov |
| May 15, 2026 | 98767 | Class II | Ongoing | HarmonyAIR A-Series Surgical Lighting System | There is a potential for paint delamination (chipping/peeling) on the lighting system's light heads. | accessdata.fda.gov |
| November 19, 2025 | 97986 | Class II | Ongoing | 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 | Wire connected to the electrical box may shift out of its intended position, which may result in electrical arcing. Electrical arcing remains internal within the unit (no risk of shock to users). | accessdata.fda.gov |
| June 23, 2025 | 97068 | Class II | Ongoing | Dual Flat Panel Monitor (DFPM) accessories for HarmonyAIR A-Series Surgical Lighting Systems | The DFPM yoke assembly ("yoke assembly") may detach from the spring arm. Should the yoke assembly detach from the spring arm, the yoke assembly would not be expected to fully detach but rather hang from the wiring within the yoke assembly. | accessdata.fda.gov |
| May 23, 2025 | 98266 | Class II | Ongoing | Barco MNA with the HexaVue IP Integration System, Model/Catalog Number: MNA-6x0-H | This is a sub-recall of event RES 96885. The supplier identified that during their manufacturing process for a limited batch of MNA-6x0 (adapter) components the incorrect configuration file was used. | accessdata.fda.gov |
| June 13, 2024 | 94987 | Class II | Ongoing | 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 | IFU for hookup were incorrectly reflected within hookup IFUs and online reference system, Hookup Lookup (HULU). Use of an incorrect hookup connection and/or parameter set may prevent an endoscope from being properly disinfected, which may present a risk of patient contamination or infection | accessdata.fda.gov |
| December 12, 2023 | 93733 | Class II | Ongoing | Dual Articulating Headrest, Pad Ret P/N P141210805, REF BF754 | Dual-articulating head rest may not stay in place or may fail to lock into position during a patient procedure which could result in an injury to the patient or a procedural delay. | accessdata.fda.gov |
| November 16, 2023 | 93610 | Class II | Ongoing | 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 | Bandage Scissors handle cover component contains an incorrect color masterbatch resin carrier. This may allow a pink dye/residue to appear on the Bandage Scissors and/or sterilization pouches after processing. | accessdata.fda.gov |
| November 13, 2023 | 93566 | Class II | Ongoing | 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, OLYMPUS 2-8-014 HOOKUP, | Identification label on affected hookups could become illegible over time due to the label's ink coming off. This may potentially prevent users from being able to effectively identify the hookup and may ultimately result in postponement of patient procedures. | accessdata.fda.gov |
| April 10, 2023 | 92044 | Class II | Ongoing | Reliance Vision Multi-Chamber Washer/Disinfector, Reference Number FH83062 | In the remote occurrence in which the electrical contactor component present in the drying chambers of the Reliance Vision Multi-Chamber Washer/Disinfector malfunctions, the heating elements in the drying chamber could overheat, eventually resulting in smoke and/or fire. | accessdata.fda.gov |
| March 17, 2023 | 92040 | Class II | Ongoing | 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 handles for sterile su | Light handle covers may separate from the light handle (detach and fall off) during use, this could result in a procedure delay and/or impact the sterile field which could result in an injury to the patient | accessdata.fda.gov |
| December 12, 2022 | 91315 | Class II | Ongoing | 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 processes | Biological indicator (BI) used to promote growth of the G. stearothermophilus and B. atrophaeus spores was inconsistent in promoting growth throughout lot, some BIs within the lot performed as intended while others did not. When used to monitor steam and ethylene oxide sterilization cycles, the potential hazard is that the BI will show no growth indicating t | accessdata.fda.gov |
| October 17, 2022 | 91020 | Class II | Terminated | 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 applications. MODEL #(s): G111 | Two electronic diode components (D1 & D4) placed in the reverse orientation on the controller printed circuit board assembly may result in premature wear of the power regulator, leading to the regulators failure which could cause a full power loss. If the regulator failure were to occur during a patient procedure, a procedural delay may result | accessdata.fda.gov |
| September 2, 2022 | 90837 | Class II | Terminated | Hu-Friedy K360 Scalpel Handle, 360 Degree Scalpel Handle, REF K360 | The scalpel holder may separate from the handle for certain lots. If the tip falls off during use, it could fall into the patient's mouth which may result in a cut to the patient's mouth and also presents a choking hazard. | accessdata.fda.gov |
| April 22, 2022 | 90222 | Class II | Terminated | Reliance Synergy Washer/Disinfector | The firm identified that when the electrical contactor component in the drying chamber of the Washer/Disinfector malfunctions, the heating elements in the drying chamber could overheat, eventually resulting in smoke and/or fire. | accessdata.fda.gov |
| March 22, 2022 | 90050 | Class II | Terminated | 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 | Product not approved for release for US distribution | accessdata.fda.gov |
| January 21, 2021 | 87230 | Class II | Terminated | OT1000 Series Orthopedic Surgical Tables | On January 7, 2021, STERIS identified that the glued bond between the beam and the leg spar assembly may begin to separate over time. This could result in unexpected movement of the affected leg spar if the separation occurred during a patient procedure. | accessdata.fda.gov |
| December 11, 2020 | 86937 | Class II | Terminated | 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 urinals, rubber and plast | The electrical contactor component present in the drying chamber of the Reliance Vision Single-Chamber Washer/Disinfector may malfunction, potentially leading to the heating elements in the drying chamber to overheat, eventually resulting in smoke and/or fire. | accessdata.fda.gov |
| December 2, 2020 | 86942 | Class II | Terminated | Vis-U-All High Temperature Tubing 3"x100'. One roll per box; 10 boxes per case 10 rolls/cs Model Number: 881031 | Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following steam processing causing cosmetic defects on the exterior of the pouch and in some instances, transference of the ink onto the device(s) contained within the pouch | accessdata.fda.gov |
| November 19, 2020 | 86906 | Class II | Terminated | Medisafe Distal Duck Kit and Duck Bag, Cleaner, ultrasonic, medical instrument - Product Usage: intended to keep instruments moist during transportation between point of use and cleaning as an initial step of reprocessin | STERIS has identified that certain lots of diluted 4-Zyme may contain bacteria, specifically Pseudomonas fluorescens. The presence of this bacteria can cause the color of the detergent to darken over time. There is an improbable risk to users of the product from exposure to this bacteria, and no risk to patients. | accessdata.fda.gov |
| October 7, 2020 | 86596 | Class III | Terminated | Olympus Leak Test Adapter used with Acu-sInQ Complete Endoscope Cleaning Aid Systems-intended to assist manual flexible endoscope cleaning Part number: 0600818OKN | Potential for cleaning solution intrusion into endoscope | accessdata.fda.gov |
| June 26, 2020 | 85871 | Class II | Terminated | InnoWave Sonic Irrigator, There are currently six models (PCF, Pro, Ultra, Ultra+, Unity, and ECO) - Product Usage: STERIS InnoWave Sonic Irrigators are intended to thoroughly clean (remove tissue, blood, and other conta | A recent FDA inspection at the firm identified that the foil test performed during installation of the device does not have clear acceptance criteria. | accessdata.fda.gov |
| October 22, 2019 | 84229 | Class II | Terminated | Evolution Loading Car and Transfer Carriage- Accessory to the Sterilizer, Steam | The locking pin of the front wheel asse mbly of the Evolution Transfer Carriages may not remain full y engaged with the transfer carriage and result in the transfer carriage and loading car unexpectedly falling forward | accessdata.fda.gov |
| October 22, 2019 | 84185 | Class II | Terminated | Eagle 3000 Sterilizer, small steam sterilizer. Product Usage: The Eagle 3000 Small Sterilizer is designed for sterilization of certain materials used in healthcare facilities, and are available in two configurations: Gra | Potential for the incorrect pressure safety valve being included in the Preventive Maintenance (PM) kit for the 3000 Small Sterilizers. | accessdata.fda.gov |
| December 26, 2018 | 82023 | Class II | Terminated | ATLAS Loading Car | The ATLAS loading car may not remain fully engaged with the latch on the transfer carriage when the loading car is empty, potentially resulting in the loading car unexpectedly sliding forward or falling to one side. | accessdata.fda.gov |
| December 20, 2018 | 82035 | Class II | Terminated | AMSCO 3000 Series Washer/Disinfector Model # 3052 | The software in the systems may not process the cycle originally intended. This could result in damage to the various medical devices and instruments processed in the washer/disinfector or potential for inadequate cleaning or disinfection. | accessdata.fda.gov |
| July 26, 2018 | 80805 | Class II | Terminated | AMSCO V-PRO 1, V-PRO 1 Plus, and V-PRO maX Low Temperature Sterilization Systems The V-PRO 1, V-PRO 1 Plus, and V-PRO maX Low Temperature Sterilization Systems, using VAPROX HC Sterilant, are intended for use in the term | There is the potential for a scenario where a punctured cup of sterilant expires while the system is powered down, upon power-up the unit will not detect the expired cup of sterilant; allowing for subsequent cycles to be run. | accessdata.fda.gov |
| May 23, 2018 | 80255 | Class II | Terminated | Reliance 1227 Cart and Utensil Washer/Disinfector, FW03101, FW03102, FW03S003 Product Usage: The Reliance 1227 Cart and Utensil Washer/Disinfector is intended for use in the cleaning and low-level disinfection of bedpans | The firm has become aware that the Reliance 1227 Cart and Utensil Washer/Disinfector s Chemical Low Level alarm, intended to prevent the user from initiating a cycle when a low chemical level situation occurs, does not operate as intended. Currently, if a low chemical level situation occurs, the alarm will only be generated at the unit s next power-up or whe | accessdata.fda.gov |
| September 28, 2017 | 79101 | Class II | Terminated | 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. | accessdata.fda.gov |
| June 15, 2017 | 79100 | Class II | Terminated | Vis-U-All High Temp 7.5"x13" Self Seal Pouch 200 pouches per box; 4 boxes per case Product Usage: The Vis-U-All High Temperature Sterilization Pouch is suitable for use by healthcare providers to enclose and seal medical | On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate following steam processing causing cosmetic defects on the exterior of the pouch and in some instances, transference of the ink onto the device(s) contained within the pouch. | accessdata.fda.gov |
| October 5, 2016 | 75385 | Class II | Terminated | Harmony Insight Diagnostic Monitor Support System - 100 Spring Arm (EMS) The system is intended for use in surgical operating rooms (OR) or intraoperative surgical/imaging rooms where simultaneous multiple image viewing | The Drager Pendula spring arm device has a set of screws located on the spring arm that were not properly secured with Loctite and may become loose. | accessdata.fda.gov |
| May 23, 2016 | 74264 | Class II | Terminated | OT1000 Series Orthopedic Surgical Tables | STERIS has identified that the pivot pin assembly located on the table top may become loose preventing the table from articulating properly. | accessdata.fda.gov |
| December 4, 2015 | 73009 | Class II | Terminated | Quick Connects. Steris Corporation. Model numbers: QKC1736E, QKC1736INT, QKC1737E, and QKC1737INT. Each Quick Connect contains a flow unit consisting of tubing, tethers, and adapters. For sterilant and rinse water used i | The firm discovered that one of the hysteroscope models listed for processing in four existing Quick Connects has one inlet port rather than two inlet ports as indicated in the Quick Connect processing instructions. | accessdata.fda.gov |
| November 20, 2015 | 72825 | Class II | Terminated | AMSCO Warming Cabinet. Manufactured by: STERIS Corporation To raise the temperature of blankets, linens and sterile surgical IV/irrigation solutions to an acceptable level for various surgical, obstetrical, emergency, cr | The firm discovered that information printed on the quick reference magnet is incorrect; specifically, Fahrenheit to Celsius temperature conversions and the default Warming Cabinet temperature. | accessdata.fda.gov |
| September 3, 2015 | 72217 | Class III | Terminated | AMSCO 400 and AMSCO C Small Steam Sterilizers | In AMSCO Small Steam Sterilizers equipped with the CS-iQ feature, the sterilizer software inadvertently prevents the capability to operate the foot pedal, which allows the Operator to open and close the sterilizer door. | accessdata.fda.gov |
| February 19, 2015 | 70938 | Class II | Terminated | AMSCO C and AMSCO 400 Steam Sterilizers, STERIS Corporation. AMSCO C Small Sterilizer, AMSCO 400 Small Sterilizer, AMSCO 400 Medium Sterilizer. Designed for sterilization of heat and moisture-stable materials used in hea | STERIS has identified that the control board software in select AMSCO 400 and AMSCO C units will interrupt and cancel a processing cycle should the selected sterilizer shutdown time coincide with a processing cycle. This may result in a procedure delay. | accessdata.fda.gov |
| February 19, 2015 | 70899 | Class II | Terminated | Caviwave Pro Ultrasonic Cleaning System, Product Usage: To wash (remove tissue, blood and other contaminants) or dry laparoscopic and general surgical instruments prior to final disinfection and sterilization as required | Should the Caviwave Pro Ultrasonic Cleaning System experience a temporary interruption in electrical power during a processing cycle, the circulation pump may stop functioning. In addition, it is possible that the ultrasonic generator may stop working. The machine does not provide an alert notifying the user of this device malfunction. | accessdata.fda.gov |
| November 26, 2014 | 69987 | Class II | Terminated | Harmony vLED Surgical Lighting System, one unit packaged per box The Harmony vLED Surgical Lighting System is a variable pattern, variable intensity surgical lighting fixture designed to provide visible illumination of t | STERIS has learned that groups of LED lights (modules) contained within the vLED light head may illuminate inconsistently. | accessdata.fda.gov |
| October 10, 2014 | 69472 | Class II | Terminated | The 5085 is a general surgical table with high patient weight capacity, extended width capability, and lower minimal table top elevation. | The 5085 and 5085SRT stainless steel column shrouds may become damaged as a result of misalignment during extreme table articulation, excessive side force on the table column, or pressure on the base of the table. Severe damage to the shrouds may prevent the user from raising or lowering the surgical table. | accessdata.fda.gov |
| June 30, 2014 | 68696 | Class III | Terminated | Reliance 1227 Cart and Utensil Washer/Disinfector Product Usage: Usage: The Reliance 1227 Cart and Utensil Washer/Disinfector is intended for use in the cleaning and low-level disinfection of bedpans and urinals, basins, | STERIS has identified that deformation of the washers door handle pin may occur when the door handle is rotated with sufficient force. Should deformation and/or breakage of the door handle pin occur there is a potential for the washer door to become inoperable. | accessdata.fda.gov |
| June 27, 2014 | 68678 | Class II | Terminated | The STERIS 4085 General Surgical Table Product Usage: is an electro-hydraulically operated surgical table designed to support all general surgical procedures. | STERIS engineering analysis has determined the D1 pressure switch in the hydraulic column manifold does not adequately detect pressure level. If one or more of the table floor lock feet become unlocked due to the loss of hydraulic pressure, there is a potential for the table hand control to incorrectly indicate that the floor lock feet are locked. | accessdata.fda.gov |
| April 4, 2014 | 68128 | Class II | Terminated | Vertical Spring Arm for Single or Dual Monitor Mount (Harmony LL 500 and Harmony LL 700 surgical lighting systems), Steris Corporation. Model numbers YG19051 and YG19262. | Potential for the welded seam in affected monitor spring arms to crack and/or break. | accessdata.fda.gov |
| December 19, 2013 | 67308 | Class II | Terminated | VERIFY SixCess 270FP Challenge Pack, STERIS Corporation, 5960 Heisley Road, Mentor, OH 44060,. The VERIFY SixCess 270FP Challenge Pack is used to monitor steam sterilization loads processed at 270F using typical healthca | STERIS has identified that the outer shipping package for one lot (Lot #024552A) of VERIFY SixCess Challenge Packs incorrectly identifies the lot as Lot #024522A. | accessdata.fda.gov |
| November 21, 2013 | 67002 | Class II | Terminated | SYSTEM 1E Liquid Chemical Sterilant Processing System, Distributed by STERIS Corporation, Mentor, OH The SYSTEM 1E Liquid Chemical Sterilant Processing System is intended for the liquid chemical sterilization of manually | 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. | accessdata.fda.gov |
| October 18, 2013 | 66874 | Class II | Terminated | AMSCO Evolution steam sterilizer Transfer Carriage. Product Usage: Mobile, wheeled transportation unit utilized to carry, load, & unload the Loading Car into and out of steam sterilizer units. | The firm discovered that unlatching can occur when overloaded transfer carriages are pulled or maneuvered incorrectly or with excessive force. | accessdata.fda.gov |
| September 10, 2013 | 67036 | Class II | Terminated | VERIFY Dual Species Self-Contained Biological Indicator, Distributed by STERIS Corporation, Mentor, OH. Intended for use in installation testing and routine monitoring of steam sterilization and ethylene oxide sterilizat | STERIS has identified that the population of the G. stearothermophilus spores that monitor STEAM sterilization cycles does not meet specifications for Lot # 131004 of the Verify Dual Species Self-Contained Biological Indicators. As a result the spore count on the affected product is lower than the labeled minimum and the product may incorrectly indicate that | accessdata.fda.gov |
| August 29, 2013 | 66247 | Class II | Terminated | Reliance Endoscope Processing System (REPS), STERIS Corporation, 5960 Heisley Road, Mentor, OH 44060-1834 USA www.steris.com. The intended use of the REPS is washing and high level disinfection of up to two manually pre- | The air pipe that delivers unfiltered ambient air from the procedure room into the water bottle on the listed FUJINON G5 & G8 type flexible GI endoscopes does not connect to the main air/water channel within the light guide (LG) connection head and, as a result, the air pipe does not receive forced flow during the Reliance EPS processing cycle. | accessdata.fda.gov |
| August 15, 2013 | 66138 | Class II | Terminated | Harmony Equipment Management System, Model #603X/80XX, STERIS Corporation, Mentor, OH Harmony Equipment Management Systems (EMS) are used in hospital facilities to provide ready access to medical gasses, electrical power | Drger Medical GmbH has notified STERIS of the potential for a break in the drive screw contained in the motorized ceiling supply unit, a component of the Harmony EMS system. The ceiling supply unit controls the motorized adjustment of the height and rotation of the supply column. Should a break occur in the drive screw, there is potential for the adjustable | accessdata.fda.gov |
| May 20, 2013 | 65573 | Class II | Terminated | STERIS Fine Traction Device, one unit per box Product Usage: The Fine Traction Device is used to provide traction and enable fine adjustments to traction and orientation of the leg during orthopedic procedures. | A bearing used in the assembly of the Fine Traction Device did not perform successfully in pre-release reliability testing; a replacement bushing passed reliability testing and was substituted per a change order. The change order authorized use of the substitute bushing in assembly of the Fine Traction Accessory; however, inadvertently the new part was not i | accessdata.fda.gov |
| March 4, 2013 | 65138 | Class II | Terminated | Quick Connect QLC1677E, QRC1699E, QPC1721E and QFC1683E. STERIS Corporation, Mentor, OH 44060 QLC1677E, QRC1699E, QPC1721E and QFC1683E contain processing instructions, a Quick Reference Wall Chart and a flow unit. The f | During a routine label review, the firm identified four SYSTEM 1E Quick Connects that will be updated to reflect the removal of obsolete device models. This labeling review process also highlighted the opportunity to combine two existing quick connects into a single product while eliminating the obsolete models. | accessdata.fda.gov |
| February 12, 2013 | 64440 | Class II | Terminated | AMSCO C and AMSCO 400 Steam Sterilizers designed for sterilization of heat and moisture-stable materials used in healthcare facilities. | The control boards alarm set points and temperature tolerances allowed for erroneous activation of the AD (analog/digital) alarm as temperature fluctuated during operation. When this alarm occurs, the sterilizer locks up and cannot be used until serviced, causing Customer nuisance. | accessdata.fda.gov |
| August 10, 2012 | 62776 | Class II | Terminated | QKC1692E The QKC1692E Quick Connect device connects endoscopes to the sterilization tray for C1220E liquid chemical sterilization processor. | STERIS has been actively seeking devices for quick connect revalidation projects. STERIS was unable to obtain two (2) of the needed devices; these two devices represent the design of seven (7) models in one quick connect. Due to the unavailability of these two validation devices, STERIS will remove 7 models from the labeling of QKC1692E and will re-label all | accessdata.fda.gov |
| August 2, 2012 | 62852 | Class III | Terminated | 100 ft roll of tubing inside a cardboard box. Medical devices are sealed into the tubes prior to ethylene oxide sterilization. Tube maintains sterility of the enclosed medical devices until opened. | On 7/20/2012 the firm became aware that a lot of tubing was distributed by the supplier after it was rejected by Steris due to failing process indicators. | accessdata.fda.gov |
| August 1, 2012 | 62895 | Class II | Terminated | The SYSTEM 1E Liquid Sterilant Processing System. The SYSTEM 1E Liquid Sterilant Processing System is intended for the liquid chemical sterilization of manually cleaned immersible and reusable critical and semi-critical | The firm initiated a recall after complaint investigations revealed that when the units are left on and not in use at night and/or on weekends the hose disconnects/separates resulting in water leakage that can cause damage to property. | accessdata.fda.gov |
| July 14, 2012 | 62557 | Class II | Terminated | The Reliance 130 and 130L Cart Washer/Disinfector is a high capacity mechanical washer intended for use in the washing, low-level disinfecting, and drying of carts, utensils, beds and other miscellaneous reusable items u | To ensure that users are properly operating the Reliance 130 and 130L Cart Washers, a door close confirmation button and door open delay will be installed on your cart washer. | accessdata.fda.gov |
| July 3, 2012 | 63129 | Class II | Terminated | Verify Bowie-Dick Test Card, Model #S3098, Steris Biological Operations, 9325 Pinecone Drive, Mentor, OH 44060 The Verify Bowie-Dick Test Card consists of a card printed on one side with bars of chemical indicator ink. O | STERIS has learned that the Verify Bowie Dick Test Cards are not performing to product specifications. Specifically, test cards have resulted in false fail results when sterilizer performance is within acceptable ranges. | accessdata.fda.gov |
| April 6, 2012 | 63142 | Class II | Terminated | STERIS 5085 and 5085 SRT Surgical Tables, Product Usage: The 5085 is a general surgical table with high patient weight capacity, extended width capability, and lower minimal table top elevation. It accommodates all gener | STERIS has learned from Customer feedback and field service experience that damage from external impact to the table hydraulic column can cause the stainless steel shroud sections covering the table hydraulic column to become misaligned; if the damage is severe, the up/down movement of the table may be impeded. In addition, the table hand control may indicat | accessdata.fda.gov |
| March 23, 2012 | 61786 | Not yet classified | Terminated | The Evolution steam sterilizers, manufactured by Steris Corporation, utilize a loading system to assist the operator in transporting, loading and unloading items to be sterilized. It consists of two major components: -Lo | Through Customer feedback and field service experience, STERIS learned that operators may experience difficulty when inserting or removing equipment from the Evolution sterilizer using the transfer carriage due to the following issues with the transfer carriage. 1) Deformation of the latch pin or cracked ball bearings preventing the roller from turning. 2) T | accessdata.fda.gov |
| October 17, 2011 | 60305 | Not yet classified | Terminated | STERIS 5085 and 5085SRT Surgical Tables, Catalog Numbers: 5085- ST01-410-1; 5085SRT- ST0-1420-6. | Some hydraulic column cylinders installed in certain 5085 and 5085SRT Surgical Tables were assembled by their supplier with incorrect snap rings and an anomaly was present in the tilt cylinder. This error may affect the user's ability to move the table top out of the full right tilt position. | accessdata.fda.gov |
| August 11, 2011 | 59752 | Not yet classified | Terminated | SYSTEM 1E Liquid Chemical Sterilant Processing System, Model # P6500, S/N: 400001 through 405005; Mfr. By: STERIS Corporation, Mentor, OH 44060. Product Usage: The SYSTEM 1E Liquid Chemical Sterilant Processing System is | STERIS learned that SYSTEM 1E users may experience aborted cycles due to a failure within the UV light system. | accessdata.fda.gov |
| August 1, 2011 | 59520 | Not yet classified | Terminated | Amsco V-PRO 1 and Amsco V-PRO 1 Plus Low Temperature Sterilization Systems Model #MLR, Serial # 033250701 - 031581115. The STERIS Amsco V-PRO and V-PRO 1 Plus Low Temperature Sterilizer are self-contained stand alone dev | STERIS learned that Amsco V-PRO 1 and V-PRO 1 Plus Low Temperature Sterilization Systems users may experience premature wear of the vacuum pump and filtering assembly components. Users may also experience incomplete aeration of the device's chamber following a failed leak test. | accessdata.fda.gov |
| May 9, 2011 | 59570 | Not yet classified | Terminated | Reliance Vision Single Chamber Washer/Disinfector, Model # 1802983, The Vision Single Chamber Washer is intended for use in the cleaning and intermediate level disinfection of soiled reusable utensils, trays, glassware, | STERIS learned that Vision SC Washer users were experiencing nuisance alarms and/or aborted cycles that are adversely affecting the reliability and operation of their unit. | accessdata.fda.gov |
| March 16, 2011 | 59713 | Not yet classified | Terminated | Verify SixCess Indicator Strips, Model #: PCC005, PCC006, PCC007, PCC008, PCC031, PCC033, PCC034, PCC037 & PCC038, Mfr. By: Albert Browne, LTD, Chancery House 190 Waterside Rd. Hamilton Industrial Park, Leicester, Leices | During an inspection the firm was notified that language contained in labeling and promotional literature directs Customers that the products can be used to replace biological indicators and/or release loads containing implants. | accessdata.fda.gov |
| February 18, 2011 | 58107 | Not yet classified | Terminated | Harmony LA/LED Monitor Arm Adapter. Model Number: LB61 The Harmony LA/LED Monitor Arm Adapter is an accessory to the Harmony LA and LED Surgical Lighting System and is attached to the end of the monitor suspension arm to | The arm adapter does not contain labelling specifying the applicable weight and moment limitations of the arm adapter | accessdata.fda.gov |
| August 12, 2010 | 56659 | Not yet classified | Terminated | Cmax Surgical Tables, Model #'s: Cmax110, Cmax 220 manufactured by Steris Corporation in Montgomery, AL | Cmax Surgical Tables may lose calibration if the table is operated only on battery power and if the table is in a low battery charge condition. This could result in the table moving into an unexpected tilt position when the Level button is depressed on the hand control keypad. | accessdata.fda.gov |
| July 2, 2010 | 56245 | Not yet classified | Terminated | Steris Reliance EPS Endoscope Processing System, manufactured by Corporation STERIS Canada, Quebec, Canada. Washing and high level disinfection of up to two manually pre-cleaned, immersible, reusable, heat-resistant, sem | Reliance EPS had internal water leaks and interrupted cycles when air leaks triggered false Fault 38 alarm that DG/HLD cup has not been replaced. | accessdata.fda.gov |
| May 14, 2010 | 55850 | Not yet classified | Terminated | STERIS 4085, 5085 & 5085SRT Surgical Tables | STERIS has learned that a limited quantity of manifold assemblies were manufactured by our supplier with incorrect washers and springs in the valves of the manifold. This supplier error has the potential to cause: a) an inability to articulate/move a table section when commanded by the operator; b) two different articulations occurring when a single articula | accessdata.fda.gov |
| February 23, 2010 | 54742 | Not yet classified | Terminated | Harmony Lux Advantage LA Surgical Lighting and Visualization System, also known as the Harmony LA 500, B129382391. Designed to provide visible immunization of the surgical field or the patient and to provide audio-visual | Premature Bulb Failure | accessdata.fda.gov |
| February 17, 2010 | 54705 | Class II | Terminated | A mobile, electro-hydraulically operated, fluoroscopic/C-Arm compatible general surgical table. Product Usage: Product provides a flexible, easy-to-use, articulated posturing of a patient for either general, I.A., or spe | Customers may be storing objects on the base and/or around the column of the surgical table. This prohibited practice and misuse known by the customers can damage the override switch assembly located at the top of the column cover. Depending upon the nature and severity of the damage to the electronics of the table, it is possible that the table could move w | accessdata.fda.gov |
| September 11, 2009 | 53475 | Not yet classified | Terminated | STERIS Harmony LL 500/700 Surgical Light, Vertical Spring-Loaded Arm. Intended for local illumination of the operating and examination area of the patient in treatment rooms. | Drger Medical AG & Co., KGaA informed STERIS Corporation that they received (4) reported international cases where a welded seam at the joint of the spring-loaded arm of the Drger SOLA 500/700 surgical light broke as a result of a crack that had slowly developed over time. The STERIS Harmony LL 500/700 surgical light is a Private Label version of the Drger S | accessdata.fda.gov |
| May 12, 2009 | 52172 | Not yet classified | Terminated | Cmax 110v Surgical Table Hand Control. The Cmax Surgical Table is a mobile, electro-hydraulically operated surgical table designed to support all general surgical procedures, with the addition of STERIS table accessories | A limited quantity of the Cmax Hand Controls, P150832-500, were manufactured without Loctite thread locker on the screws that attach the mounting clip to the hand control case. This clip provides a means of storing the hand control on the table side rails. It is possible that screws without Loctite can work loose and the clip can become separated from the ha | accessdata.fda.gov |
| April 17, 2009 | 51953 | Not yet classified | Terminated | ASC2000 Ambulatory Surgical Table. Model #MTS110003. The device is used to provide complete and flexible positioning for surgical procedures. | Upon investigation, the firm determined that repetitive rubbing of the hydraulic hoses against the interior of the stainless steel shroud may result in the rupture of the hydraulic hoses causing loss of control of the table surface. | accessdata.fda.gov |
| August 4, 2008 | 49390 | Not yet classified | Terminated | Quick Connect component p/n 201048. The component is contained in QPC1713 and QPC1724 Quick Connects. The QPC1724 is used to attach Pentax 70/70K/72/72K/80K/81K/90i/90K SERIES GI ENDOSCOPES WITH WATER JET to the C1160 Un | During ongoing product development testing, it was discovered that, when the two inflow barbs on adapter 201048 # 4 are in a position to face one direction, the top Barblock may interfere with the top surface of bottom barb of the adapter. The interference may cause the plunger on the suction side to lift slightly which may affect flow of sterilant into the | accessdata.fda.gov |
| March 6, 2008 | 48999 | Not yet classified | Terminated | Steris Small Renaissance Eagle 3000 -- Remanufactured Gravity Models 3011 and 3021 and Prevacuum Models 3013 and 3023. Products are designed for efficient sterilization of non-porous and porous, heat and moisture-stable | The firm discovered that some Eagle 3000 units may have a door post pin missing which could cause incomplete or no engagement of the radial arms into the lock rails of the door. The sterilizer is designed with switches that prevent cycle initiation if the door is not locked. However, in the event the door switches are not properly adjusted they may falsely i | accessdata.fda.gov |
| February 19, 2008 | 46753 | Not yet classified | Terminated | Steris C1160 Universal Flexible Processing Tray, for use with STERIS SYSTEM 1 Processor, used for sterilization of flexible endoscopes. | Failure to effectively sterilize: Under certain conditions, the design/operation of the C1160 Tray may compromise the ability of the SYSTEM 1 processor to correctly assess the state of the high pressure pump during the Sterile Cycle. The L6 sensor fails to alarm when the high pressure pump is not working properly. | accessdata.fda.gov |
| March 22, 2007 | 38031 | Not yet classified | Terminated | Amsco Century Medium Steam Sterilizer (26" x 37.5") (660 x 950mm). | The cables inside the pump conduit box may be exposed (not covered with wire nut and/or electrical tape) that could cause a potential electrical shock hazard. | accessdata.fda.gov |
| February 23, 2007 | 37493 | Not yet classified | Terminated | Steris QFC1728 and QFC1729 Quick Connects used in connections and processing endoscopes. The QFC1728 is used to process the Fujinon 250/270/450/470/490 Group 5 and 530/590 series GI Endoscopes w/o Water Jet. The QFC1729 | The center insert of the adaptor #6 restrictor could become loose and/or come out of the housing and may affect the sterilization process of the attached endoscope | accessdata.fda.gov |
| March 15, 2004 | 28569 | Not yet classified | Terminated | QPC1680 Quick Connect, for Pentax 30/40/K Series Two-Channel GI Endoscopes, in the Steris System 1 Sterile Processing System with the C1160 Universal Flexible Processing Tray, Cat No. QPT1680 | A defective port adapter may affect the sterilization process of the attached endoscope. | accessdata.fda.gov |
| April 23, 2003 | 26151 | Not yet classified | Terminated | C1141 Flexible Endoscope Processing Container, designed to fit the Steris System I Processor. The unit may be sold individually or with the processing tray assembly (C1140). | The container flow port is inverted, which restricts the flow of sterilant to the endoscope and affects the sterilization process. | accessdata.fda.gov |
| March 20, 2003 | 25946 | Not yet classified | Terminated | QFC1631, QFC1683, QFC1685 Quick Connects for use with Fujinon gastrointestinal endoscopes, for use with the STERIS SYSTEM I Processor and the C1160 Universal Flexible Processing Tray. The QFC1631 is for Fujinon 450/485 S | The defective device may restrict the flow of sterilant to the attached endoscope and affect the sterilization process of the scope. | accessdata.fda.gov |
| March 7, 2003 | 25374 | Not yet classified | Terminated | C1406, QLC1406, C1473, and QLC1473 Quick Connect for Olympus 30/40/160/200/240 Series Bronchoscopes in the C1140 Universal Processing Trays. Catalog numbers: C11473 and QLC1473. | The Steris device may not attach properly to retrofitted Olympus bronchoscopes, and become loose during the sterile processing cycle. | accessdata.fda.gov |
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Updated October 7, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.