Steris Corporation: FDA recalls

FDA enforcement reports name Steris Corporation as the recalling firm in 58 events. The events have 112 product records. The recalls started from 2010 to 2026. All the events are device recalls.

See the 58 events

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Enforcement events

58 events, newest first.

FDA enforcement events of Steris Corporation
Initiated	Product (first record)	Type	Class	Records	Status
15 May 2026	HarmonyAIR A-Series Surgical Lighting System	Device	Class II	1	Ongoing
15 May 2026	HarmonyAIR A-Series Surgical Lighting System	Device	Class II	2	Ongoing
19 Nov 2025	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,…	Device	Class II	2	Ongoing
23 Jun 2025	Dual Flat Panel Monitor (DFPM) accessories for HarmonyAIR A-Series Surgical Lighting Systems	Device	Class II	2	Ongoing
23 May 2025	Barco MNA with the HexaVue IP Integration System, Model/Catalog Number: MNA-6x0-H	Device	Class II	1	Ongoing
13 Jun 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…	Device	Class II	4	Ongoing
12 Dec 2023	Dual Articulating Headrest, Pad Ret P/N P141210805, REF BF754	Device	Class II	2	Ongoing
16 Nov 2023	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	Device	Class II	1	Ongoing
13 Nov 2023	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, OPTIM LT 2-8-030 ASSY, HOOKUP, PENTAX-0K 2-8-040 ASSY, HKUP STORZ 0K 2-8-070 ASSY, HU VISION…	Device	Class II	1	Ongoing
10 Apr 2023	Reliance Vision Multi-Chamber Washer/Disinfector, Reference Number FH83062	Device	Class II	1	Ongoing
17 Mar 2023	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 surgeon control. REF: LB53	Device	Class II	2	Ongoing
12 Dec 2022	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	Device	Class II	4	Ongoing
17 Oct 2022	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): G1110001	Device	Class II	1	Terminated
2 Sep 2022	Hu-Friedy K360 Scalpel Handle, 360 Degree Scalpel Handle, REF K360	Device	Class II	1	Terminated
22 Apr 2022	Reliance Synergy Washer/Disinfector	Device	Class II	1	Terminated
22 Mar 2022	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	Device	Class II	2	Terminated
21 Jan 2021	OT1000 Series Orthopedic Surgical Tables	Device	Class II	1	Terminated
11 Dec 2020	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 plastic goods, simple hard-surfaced rigid surgical instruments, such as forceps and clamps, theatre…	Device	Class II	1	Terminated
2 Dec 2020	Vis-U-All High Temperature Tubing 3"x100'. One roll per box; 10 boxes per case 10 rolls/cs Model Number: 881031	Device	Class II	14	Terminated
19 Nov 2020	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 reprocessing.	Device	Class II	1	Terminated
7 Oct 2020	Olympus Leak Test Adapter used with Acu-sInQ Complete Endoscope Cleaning Aid Systems-intended to assist manual flexible endoscope cleaning Part number: 0600818OKN	Device	Class III	1	Terminated
26 Jun 2020	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 contaminants from) a variety of reusable surgical instruments. The equipment provides sonic irrigation…	Device	Class II	1	Terminated
22 Oct 2019	Evolution Loading Car and Transfer Carriage- Accessory to the Sterilizer, Steam	Device	Class II	1	Terminated
22 Oct 2019	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: Gravity designed for sterilization of non-porous, heat- and moisture stabile goods, and sterilization…	Device	Class II	1	Terminated
26 Dec 2018	ATLAS Loading Car	Device	Class II	1	Terminated
20 Dec 2018	AMSCO 3000 Series Washer/Disinfector Model # 3052	Device	Class II	2	Terminated
26 Jul 2018	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 terminal Sterilization of properly prepared (cleaned, rinsed and dried) metal and nonmetal medical…	Device	Class II	1	Terminated
23 May 2018	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 and urinals, basins, carts, beds, theatre shoes and other miscellaneous reusable items used in…	Device	Class II	1	Terminated
28 Sep 2017	V-PRO 60 Low Temperature Sterilization System (UDI: 00724995152000)	Device	Class II	1	Terminated
15 Jun 2017	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 devices to be sterilized by steam. The pouch is designed to maintain sterility of properly…	Device	Class II	29	Terminated
5 Oct 2016	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 is required	Device	Class II	1	Terminated
23 May 2016	OT1000 Series Orthopedic Surgical Tables	Device	Class II	1	Terminated
4 Dec 2015	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 in endoscope washers.	Device	Class II	1	Terminated
20 Nov 2015	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, critical care and other healthcare applications.	Device	Class II	1	Terminated
3 Sep 2015	AMSCO 400 and AMSCO C Small Steam Sterilizers	Device	Class III	1	Terminated
19 Feb 2015	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 healthcare facilities.	Device	Class II	1	Terminated
19 Feb 2015	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.	Device	Class II	1	Terminated
26 Nov 2014	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 the surgical field or the patient for the operating room staff.	Device	Class II	1	Terminated
10 Oct 2014	The 5085 is a general surgical table with high patient weight capacity, extended width capability, and lower minimal table top elevation.	Device	Class II	1	Terminated
30 Jun 2014	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, carts, beds, theater shoes and other miscellaneous reusable items used in the care of patients.	Device	Class III	1	Terminated
27 Jun 2014	The STERIS 4085 General Surgical Table Product Usage: is an electro-hydraulically operated surgical table designed to support all general surgical procedures.	Device	Class II	1	Terminated
4 Apr 2014	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.	Device	Class II	1	Terminated
19 Dec 2013	VERIFY SixCess 270FP Challenge Pack, STERIS Corporation, 5960 Heisley Road, Mentor, OH 44060, 440-354-2600. The VERIFY SixCess 270FP Challenge Pack is used to monitor steam sterilization loads processed at 270°F using typical healthcare dynamic air removal steam sterilization cycles.	Device	Class II	1	Terminated
21 Nov 2013	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 cleaned immersible and reusable critical and semi-critical heat sensitive medical devices,…	Device	Class II	1	Terminated
18 Oct 2013	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.	Device	Class II	1	Terminated
10 Sep 2013	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 sterilization processes.	Device	Class II	1	Terminated
29 Aug 2013	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-cleaned, immersible, reusable, heat-resistant, semi-critical devices.	Device	Class II	1	Terminated
15 Aug 2013	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 and audio/visual data services, in addition to managing surgical support equipment such as…	Device	Class II	1	Terminated
20 May 2013	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.	Device	Class II	1	Terminated
4 Mar 2013	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 flow unit consists of a Quick Reference Card, tubing, tethers and adapters for connecting specified…	Device	Class II	1	Terminated
12 Feb 2013	AMSCO C and AMSCO 400 Steam Sterilizers designed for sterilization of heat and moisture-stable materials used in healthcare facilities.	Device	Class II	1	Terminated
10 Aug 2012	QKC1692E The QKC1692E Quick Connect device connects endoscopes to the sterilization tray for C1220E liquid chemical sterilization processor.	Device	Class II	1	Terminated
2 Aug 2012	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.	Device	Class III	1	Terminated
1 Aug 2012	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 heat sensitive medical devices, including endoscopes and their accessories.	Device	Class II	1	Terminated
14 Jul 2012	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 used in the care of patients at healthcare facilities / Crated for shipping.	Device	Class II	1	Terminated
3 Jul 2012	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. On the opposite side of the card, space is provided for critical cycle information to be recorded.…	Device	Class II	1	Terminated
6 Apr 2012	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 general surgical procedures including but not limited to, cardiac and vascular, endoscopic, gynecology,…	Device	Class II	1	Terminated
17 Feb 2010	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 specialized surgical procedures. There are movable components and accessories intended for use during…	Device	Class II	1	Terminated

An event with 1 product record and a class that is not Class I has no page. It has a row in this table.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Recalling firm: The firm that the FDA record names for a recall.

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Type and class

Steris Corporation: events for each product type
Type		Events
Device		58

Steris Corporation: events in each class
Class		Events
Class II		54
Class III		4

Share of the events of the firm in Class I: 0%
Share of all events on the register in Class I: 18%
Events with the status Ongoing: 12

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Events by year

FDA enforcement events of Steris Corporation, by the year that the recall started. The largest year is 2013, with 9 events.

Official channels

FDA enforcement reportsThe FDA search of the weekly enforcement reports.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA: report a problemThe FDA page that shows where a report about a product goes.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

Cite this page

Recall Register. Steris Corporation: FDA recalls. https://recallregister.com/firm/steris-corporation/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
State of the firm address: OH

The firm name is the spelling in the FDA records. A company with 2 spellings has 2 pages.

A firm with more products can have more recalls. This site does not compare one firm with a different firm. How the register is made. Report an error.

Questions

Which classes do the FDA recalls of Steris Corporation have?: Class II: 54 events. Class III: 4 events. The class is for the product of a recall. It is not a class of the firm.
What is the newest FDA recall of Steris Corporation?: FDA event 98767, which the firm started on 15 May 2026. The first product in the record is: HarmonyAIR A-Series Surgical Lighting System
How many FDA recalls of Steris Corporation have the status Ongoing?: 12 events have the status Ongoing in the openFDA file. openFDA says about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.