The Recall Desk

Manufacturer

Steris Corporation

112 recalls in our database name Steris Corporation as the manufacturing or recalling firm.

What the numbers show

Total
112
Critical
1
Severe
4
Most recent
2026-06-24

Of the 112 recalls from Steris Corporation we have scored against our rubric, 1 (1%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 4 (4%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

76–100 of 112

  • LowFDA (Devices)·Z-0764-2018·2018-03-07

    Steris Recalls Vis-U-All Sterilization Pouches Due to Ink Migration

    Steris Corporation is recalling Vis-U-All High Temperature Sterilization Pouches because purple ink on the exterior label may migrate during steam processing, causing cosmetic defects and potential ink transfer to medical devices.

    Product
    Vis-U-All High Temp 18"x22" Self Seal Pouch 100 pouches per box; 5 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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0762-2018·2018-03-07

    Steris Recalls Vis-U-All High Temperature Sterilization Pouches Due to Ink Migration

    Steris Corporation is recalling Vis-U-All High Temperature Sterilization Pouches because purple ink on the exterior label may migrate during steam processing, causing cosmetic defects and potential ink transfer to devices.

    Product
    Vis-U-All High Temp 16"x16" Self Seal Pouch 100 pouches per box; 6 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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0746-2018·2018-03-07

    Steris Recalls Vis-U-All High Temperature Tubing Due to Ink Migration

    Steris Corporation is recalling Vis-U-All High Temperature Tubing because purple ink on the exterior label may migrate during steam processing, causing cosmetic defects and potential ink transfer to medical devices.

    Product
    Vis-U-All High Temperature Tubing 9"x100'. One roll per box; 10 boxes per case 6 rolls/cs 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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0771-2018·2018-03-07

    Steris Recalls Vis-U-All High Temperature Sterilization Pouches Due to Ink Migration

    Steris is recalling Vis-U-All High Temperature Sterilization Pouches because purple ink on the exterior label may migrate during steam processing, causing cosmetic defects and potential ink transfer to medical devices.

    Product
    Vis-U-All High Temp 8"x16" 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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0744-2018·2018-03-07

    Steris Recalls Vis-U-All High Temperature Sterilization Pouches Due to Ink Migration

    Steris Corporation is recalling Vis-U-All High Temperature Sterilization Pouches because purple ink on the exterior label may migrate during steam processing, causing cosmetic defects and potential ink transfer to medical devices.

    Product
    Vis-U-All High Temperature Tubing 4"x100'. One roll per box; 10 boxes per case 10 rolls/cs 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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0748-2018·2018-03-07

    Steris Recalls Vis-U-All Heat Seal Pouches Due to Ink Migration

    Steris is recalling Vis-U-All High Temp Heat Seal Pouches because purple ink may migrate onto the pouch exterior or the medical devices inside after steam processing.

    Product
    Vis-U-All High Temp 3"x8" Heat Seal Pouch 200 pouches per box; 5 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 t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0767-2018·2018-03-07

    Steris Recalls Vis-U-All Pouches Due to Ink Migration Defects

    Steris is recalling Vis-U-All High Temp Self Seal Pouches because purple ink may migrate onto the pouch exterior or the medical devices inside after steam processing.

    Product
    Vis-U-All High Temp 4"x11" 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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0754-2018·2018-03-07

    Steris Recalls Vis-U-All Heat Seal Pouches Due to Ink Migration

    Steris is recalling Vis-U-All High Temperature Sterilization Pouches because purple ink on the exterior label may migrate during steam processing, causing cosmetic defects and potential ink transfer to medical devices.

    Product
    Vis-U-All High Temp 4.5"x11" Heat Seal Pouch 200 pouches per box; 5 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 designe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0760-2018·2018-03-07

    Steris Recalls Vis-U-All Heat Seal Pouches Due to Ink Migration

    Steris Corporation is recalling Vis-U-All High Temperature Sterilization Pouches because purple ink on the exterior label may migrate during steam processing, causing cosmetic defects and potential ink transfer to medical devices.

    Product
    Vis-U-All High Temp 8"x16" Heat Seal Pouch 100 pouches per box; 9 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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0746-2017·2016-12-21

    Steris Recalls Harmony Insight Diagnostic Monitor Support Systems

    Steris Corporation is recalling 63 Harmony Insight Diagnostic Monitor Support Systems because spring arm screws may not be properly secured and could become loose.

    Product
    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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1180-2016·2016-03-23

    Steris Quick Connects Recalled Due to Hysteroscope Port Mismatch

    Steris Corporation is recalling 809 Quick Connect flow units because processing instructions incorrectly list a hysteroscope model with two inlet ports when the device has only one.

    Product
    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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0603-2016·2016-01-13

    Steris Amsco Warming Cabinet Recalled for Incorrect Temperature Labeling

    Steris Corporation is recalling Amsco Warming Cabinets because the quick reference magnet displays incorrect Fahrenheit to Celsius conversions and default temperatures.

    Product
    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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0210-2016·2015-11-11

    Steris Recalls AMSCO Steam Sterilizers Due to Foot Pedal Software Issue

    Steris Corporation is recalling 32 AMSCO 400 and AMSCO C Small Steam Sterilizers because a software defect prevents the foot pedal from operating the door.

    Product
    AMSCO 400 and AMSCO C Small Steam Sterilizers
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1559-2015·2015-05-06

    Steris Caviwave Pro Ultrasonic Cleaning System Recalled for Power Failure Risk

    Steris is recalling 491 Caviwave Pro Ultrasonic Cleaning Systems because a power interruption may stop the pump and generator without alerting the user.

    Product
    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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1561-2015·2015-05-06

    Steris Recalls AMSCO Steam Sterilizers Due to Software Defect

    Steris is recalling 701 AMSCO C and AMSCO 400 steam sterilizers because a software defect may interrupt processing cycles, causing procedure delays.

    Product
    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.
    Category
    Medical Device
    Distribution
    48 states
  • ModerateFDA (Devices)·Z-0930-2015·2015-01-14

    Steris Recalls Harmony vLED Surgical Lighting Systems Due to Inconsistent Illumination

    Steris is recalling 140 Harmony vLED Surgical Lighting Systems because LED modules may illuminate inconsistently. The units were distributed worldwide.

    Product
    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 s
    Category
    Medical Device
    Distribution
    25 states
  • HighFDA (Devices)·Z-0196-2015·2014-11-19

    Steris 5085 Surgical Tables Recalled for Damaged Column Shrouds

    Steris is recalling 5085 and 5085SRT surgical tables because column shrouds may become damaged, potentially preventing the table from raising or lowering.

    Product
    The 5085 is a general surgical table with high patient weight capacity, extended width capability, and lower minimal table top elevation.
    Category
    Medical Device
    Distribution
    36 states
  • HighFDA (Devices)·Z-2026-2014·2014-07-16

    Steris 4085 General Surgical Table Recalled for Pressure Switch Defect

    Steris Corporation is recalling 3,689 STERIS 4085 General Surgical Tables because a defective pressure switch may cause the hand control to incorrectly indicate that floor lock feet are locked.

    Product
    The STERIS 4085 General Surgical Table Product Usage: is an electro-hydraulically operated surgical table designed to support all general surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2036-2014·2014-07-16

    Steris Recalls Reliance 1227 Washer Due to Door Handle Pin Deformation

    Steris is recalling 37 Reliance 1227 Cart and Utensil Washer/Disinfector units because the door handle pin may deform or break, potentially rendering the door inoperable.

    Product
    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 reu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1850-2014·2014-07-02

    Steris Surgical Lighting Monitor Spring Arms Recalled for Welding Defect

    Steris Corporation is recalling 68 vertical spring arms for surgical lighting systems because the welded seam may crack or break.

    Product
    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.
    Category
    Medical Device
    Distribution
    5 states
  • LowFDA (Devices)·Z-1166-2014·2014-03-19

    Steris Recalls VERIFY SixCess 270FP Challenge Packs Due to Labeling Error

    Steris is recalling VERIFY SixCess 270FP Challenge Packs because the outer shipping package for one lot incorrectly identifies the lot number.

    Product
    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 sterilizatio
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0605-2014·2014-01-08

    Steris Recalls Verify Dual Species Biological Indicators Due to Spore Count Defect

    Steris is recalling Verify Dual Species Self-Contained Biological Indicators because the spore count is lower than labeled, potentially causing false sterilization results.

    Product
    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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0616-2014·2014-01-08

    Steris SYSTEM 1E Liquid Chemical Sterilant Processing System Recalled for Valve Issues

    Steris Corporation is recalling SYSTEM 1E Liquid Chemical Sterilant Processing Systems because check valve o-rings degrade, causing nuisance aborts.

    Product
    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-critic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0478-2014·2013-12-18

    Steris Recalls AMSCO Evolution Steam Sterilizer Transfer Carriages

    Steris Corporation is recalling 936 AMSCO Evolution steam sterilizer transfer carriages because they may unlatch when overloaded or maneuvered with excessive force.

    Product
    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.
    Category
    Medical Device
    Distribution
    Distributed nationwide

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

Steris

medical device company

Country
United States
Founded
1985

Official website

Source: Wikidata (Q80947821), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.