Steris Corporation recalls
Every recall we track for Steris Corporation — 94 in all, from 2017–2026 — plus the complaints and injury reports the public filed about them.
Recalls per year, by danger level
Recalls from Steris Corporation peaked in 2017 (30); 94 since 2017.
All FDA recall records for Steris Corporation since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 0 | 0 | 30 | 0 | 30 |
| 2018 | 0 | 3 | 2 | 0 | 5 |
| 2019 | 0 | 1 | 1 | 0 | 2 |
| 2020 | 0 | 0 | 18 | 0 | 18 |
| 2021 | 0 | 1 | 0 | 0 | 1 |
| 2022 | 0 | 3 | 4 | 2 | 9 |
| 2023 | 0 | 4 | 3 | 0 | 7 |
| 2024 | 0 | 4 | 0 | 0 | 4 |
| 2025 | 0 | 3 | 2 | 0 | 5 |
| 2026 (to date) | 0 | 3 | 3 | 7 | 13 |
Most common reasons for Steris Corporation recalls
What to do if you have a recalled Steris Corporation product
- Match the model, catalog or lot number on your device to the recall.
- Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals.
- Report problems to FDA MedWatch.
All Steris Corporation recalls
33 shown- Lower riskMedical device
Steris Corporation recalls HexaVue Focus Integration System, a single, all-in-one system that handles operating room video routing, surgical video
Steris recalls 58 HexaVue Focus Integration Systems with software version 2.0.18 and specific serial numbers due to risk of incorrect patient information appearing on printed images.
SterisSep 23, 2026 - Use cautionMedical device
Steris Corporation recalls RAPICIDE PA Part A High-Level Disinfectant, Model/Catalog Number: ML020115
Steris recalls 374 units of RAPICIDE PA Part A High-Level Disinfectant (model ML020115) due to potential swelling and chemical exposure if vented cap blocks, risking injury without proper PPE.
Steris CorporationSep 21, 2026 - Lower riskMedical device
Steris Corporation recalls VERIFY Biological Steam Test Pack Model/Catalog Number: S3065
Steris recalls 217 units of VERIFY Biological Steam Test Pack model S3065 with lot numbers 260810, 260810A, 261106, 270116. These packs may show no growth during steam sterilization cycles, indicating a failed cycle when it's actually effective.
SterisAug 31, 2026 - Lower riskMedical device
Steris Corporation recalls HarmonyAIR A-Series Surgical Lighting System
Steris Corporation is a global leader in medical devices, healthcare products, and infection control solutions.
SterisMay 15, 2026 - Use cautionMedical device
Steris Corporation recalls HarmonyAIR A-Series Surgical Lighting System
Steris recalls HarmonyAIR A-Series surgical lighting systems with specific UDIs due to risk of plus/minus buttons detaching during use.
SterisMay 15, 2026 - Use cautionMedical device
Steris Corporation recalls AMSCO 7052HP Washer/Disinfector Model/Catalog Number: 7052HP Product Description: The AMSCO 7052HP Washer/Disinfector
Steris recalls AMSCO 7052HP Washer/Disinfector units with potential internal electrical arcing. The hazard is internal and does not risk user shock. Affected units have specific serial numbers and lot codes.
SterisNov 19, 2025 - Use cautionMedical device
Steris Corporation recalls Dual Flat Panel Monitor (DFPM) accessories for HarmonyAIR E-Series Surgical Lighting Systems
Steris recalls Dual Flat Panel Monitor accessories for HarmonyAIR E-Series surgical lighting systems due to potential yoke assembly detachment. Affected units have specific serial numbers.
SterisJun 23, 2025 - Lower riskMedical device
Steris Corporation recalls Barco MNA with the HexaVue IP Integration System, Model/Catalog Number: MNA-6x0-H
Steris recalls Barco MNA-6x0-H models with incorrect configuration files from limited manufacturing batch. Affected units have specific serial numbers; contact Steris for remedy.
SterisMay 23, 2025 - Use cautionMedical device
Steris Corporation recalls Hookup Model/Catalog Number: 2-8-540CAS Product Description: Hookups provide the interface between an Advantage Plus"
Steris recalls Hookup model 2-8-540CAS due to potential patient contamination from improper endoscope disinfection. Affected units may prevent proper disinfection, risking infection.
SterisJun 13, 2024 - Use cautionMedical device
Steris Corporation recalls Dual Articulating Headrest, Pad Ret P/N P141210805, REF BF754
Steris recalls certain Dual Articulating Headrest models (P/N P141210805, REF BF754) due to potential failure to lock during patient procedures, risking injury or delays.
SterisDec 12, 2023 - Lower riskMedical device
Steris Corporation recalls V. Mueller Universal Bandage Scissors Black Plastic Handles Heavy-Duty, Autoclavable, Overall Length 7 (18 cm)-
Steris recalls bandage scissors with black plastic handles that may leave pink dye on sterilization pouches after use. Affected models include SU2014-001 with specific lot numbers.
SterisNov 16, 2023 - Lower riskMedical device
Steris Corporation recalls Hookup Accessories used with MEDIVATORS ADVANTAGE PLUS and ADVANTAGE PLUS Pass Thru Automated Endoscope Reprocessors
Steris recalls certain Hookup Accessories for MEDIVATORS ADVANTAGE PLUS and ADVANTAGE PLUS Pass Thru Automated Endoscope Reprocessors due to potential label degradation that could delay patient procedures.
SterisNov 13, 2023 - Lower riskMedical device
Steris Corporation recalls Reliance Vision Multi-Chamber Washer/Disinfector, Reference Number FH83062
Steris recalls Reliance Vision Multi-Chamber Washer/Disinfector models with specific serial numbers due to potential overheating in drying chambers that could cause smoke or fire.
SterisApr 10, 2023 - Use cautionMedical device
Steris Corporation recalls Steris Lighting and Visualization Systems, Sterile Light Handle Cover (LB53)- Surgical light handle covers, including
Steris recalls surgical light handle covers (LB53) that may detach during procedures, risking patient injury due to compromised sterile field. Affected units include specific lot numbers from 2023.
SterisMar 17, 2023 - Lower riskMedical device
Steris Corporation recalls VERIFY Steam Test Pack (20 Tests and 20 controls) Item Number: S3069 Intended for use in installation testing and
Steris recalls VERIFY Steam Test Pack (20 Tests) due to inconsistent biological indicator growth. This could lead to false indication of sterilization effectiveness, risking infection. Affected units have item number S3069 and lot #230613.
SterisDec 12, 2022 - Use cautionMedical device
Steris Corporation recalls GI4000 Electrosurgical Unit - intended to deliver electrosurgical outputs to perform cutting and/or coagulation and
Steris recalls GI4000 Electrosurgical Units with specific serial numbers due to potential power regulator failure during surgery, causing procedural delays. Affected units may need repair or replacement.
SterisOct 17, 2022 - Use cautionMedical device
Steris Corporation recalls Hu-Friedy K360 Scalpel Handle, 360 Degree Scalpel Handle, REF K360
Hu-Friedy recalls K360 Scalpel Handles from specific lots due to risk of tip separation causing cuts or choking during surgery.
Hu-FriedySep 2, 2022 - Lower riskMedical device
Steris Corporation recalls Reliance Synergy Washer/Disinfector
Steris Corporation is a global leader in medical device manufacturing, specializing in infection control and healthcare solutions. With a focus on quality, innovation, and safety, Steris provides products and services that help healthcare facilities maintain a clean and safe environment for patients and staff.
SterisApr 22, 2022 - UnratedMedical device
Steris Corporation recalls 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
Steris Corporation recalls non-sterile 4-ply sponges not approved for US distribution. Consumers should not use these products as they were not cleared for sale in the United States.
SterisMar 22, 2022 - Use cautionMedical device
Steris Corporation recalls OT1000 Series Orthopedic Surgical Tables
Steris recalls OT1000 series surgical tables due to risk of leg spar separation during procedures. Affected models OT1000, OT1100, OT1200 sold since 2019. No remedy specified in recall notice.
SterisJan 21, 2021 - Lower riskMedical device
Steris Corporation recalls Reliance Vision Single-Chamber Washer/Disinfector - Product Usage: intended for use in the cleaning and intermediate
Steris Corporation is a global leader in medical device manufacturing and healthcare solutions. We provide innovative products and services to improve patient care and operational efficiency in healthcare settings.
SterisDec 11, 2020 - Lower riskMedical device
Steris Corporation recalls Vis-U-All High Temp 7.5"x13.5" Heat Seal Pouch 200 pouches per box; 5 boxes per case Model Number: 883713
Steris recalls 200-pouch heat seal pouches with purple ink that may bleed after steam processing, causing cosmetic defects and ink transfer to devices. Affected units have model 883713 and lot numbers 200425A or 200625A.
SterisDec 2, 2020 - Lower riskMedical device
Steris Corporation recalls Medisafe Distal Duck Kit and Duck Bag, Cleaner, ultrasonic, medical instrument - Product Usage: intended to keep
Steris recalls Medisafe Distal Duck Kit and Duck Bag detergent lots with possible Pseudomonas bacteria. Darkening color indicates risk; no patient harm reported. Consumers should check model/lot numbers.
SterisNov 19, 2020 - Lower riskMedical device
Steris Corporation recalls Olympus Leak Test Adapter used with Acu-sInQ Complete Endoscope Cleaning Aid Systems-intended to assist manual flexible
Steris recalls Olympus Leak Test Adapter used with Acu-sInQ endoscope cleaning systems due to potential cleaning solution intrusion into endoscopes. Affected units distributed from May 2017 to June 2020.
SterisOct 7, 2020 - Lower riskMedical device
Steris Corporation recalls InnoWave Sonic Irrigator, There are currently six models (PCF, Pro, Ultra, Ultra+, Unity, and ECO) - Product Usage:
Steris recalls six models of InnoWave Sonic Irrigators due to unclear FDA test acceptance criteria during installation. Affected units have specific serial numbers. Consumers should check their serial numbers and contact Steris for details.
SterisJun 26, 2020 - Lower riskMedical device
Steris Corporation recalls Eagle 3000 Sterilizer, small steam sterilizer. Product Usage: The Eagle 3000 Small Sterilizer is designed for
Steris recalls Eagle 3000 Small Sterilizers with potential incorrect pressure safety valve in Preventive Maintenance kits. Affected units have specific serial numbers listed in the recall notice.
SterisOct 22, 2019 - Use cautionMedical device
Steris Corporation recalls Evolution Loading Car and Transfer Carriage- Accessory to the Sterilizer, Steam
Steris recalls Evolution Loading Car and Transfer Carriage accessories for steam sterilizers due to potential front wheel locking failure causing unexpected forward falls.
SterisOct 22, 2019 - Use cautionMedical device
Steris Corporation recalls ATLAS Loading Car
Steris recalls ATLAS Loading Cars with specific serial numbers due to potential sliding or falling when empty, which could cause injury. Affected units include serial numbers listed in the recall notice.
SterisDec 26, 2018 - Use cautionMedical device
Steris Corporation recalls AMSCO 5000 Series Washer/Disinfector Model # 5052
Steris recalls AMSCO 5000 Series Washer/Disinfector Model #5052 due to software issues that may cause medical instruments to be inadequately cleaned or disinfected. Affected units have specific serial numbers listed in the recall.
SterisDec 20, 2018 - Lower riskMedical device
Steris Corporation recalls 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
Steris Corporation is a global leader in medical device manufacturing and healthcare solutions. We provide innovative products and services to improve patient care and operational efficiency in healthcare settings.
SterisJul 26, 2018 - Use cautionMedical device
Steris Corporation recalls Reliance 1227 Cart and Utensil Washer/Disinfector, FW03101, FW03102, FW03S003 Product Usage: The Reliance 1227 Cart and
Steris recalls Reliance 1227 Cart and Utensil Washer/Disinfector models FW03101, FW03102, FW03S003 due to chemical low level alarm failure that may cause improper cleaning of patient items.
SterisMay 23, 2018 - Lower riskMedical device
Steris Corporation recalls V-PRO 60 Low Temperature Sterilization System (UDI: 00724995152000)
Steris recalls V-PRO 60 Low Temperature Sterilization System with serial numbers listed; update software to prevent using expired sterilant before sterilization cycles start.
SterisSep 28, 2017 - Lower riskMedical device
Steris Corporation recalls Vis-U-All High Temp 4"x8" Heat Seal Pouch 200 pouches per box; 5 boxes per case Product Usage: The Vis-U-All High
Steris recalls 200-pouch heat seal pouches that may develop cosmetic defects and transfer ink to medical devices after steam processing. Affected units have purple ink labels that could migrate during sterilization.
SterisJun 15, 2017
Steris Corporation recall questions
How many recalls has Steris Corporation had?
94 recalls from Steris Corporation are on record with U.S. safety agencies, from 2017–2026.
What is the most recent Steris Corporation recall?
Steris Corporation recalls HexaVue Focus Integration System, a single, all-in-one system that handles operating room video routing, surgical video, dated Sep 23, 2026. Every Steris Corporation recall is listed on this page, newest first.
Why are Steris Corporation products recalled?
The most common reasons on record: Product not approved for release for US distribution (2).
What should I do if I have a recalled Steris Corporation product?
Match the model, catalog or lot number on your device to the recall. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals. Report problems to FDA MedWatch.
How do I get alerts for new Steris Corporation recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.