The Recall Desk

Manufacturer

Steris Corporation

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

What the numbers show

Total
122
Critical
1
Severe
11
Most recent
2026-10-21

Of the 122 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 11 (9%) 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.

101–122 of 122

  • 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…
    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…
    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…
    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…
    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
  • HighFDA (Devices)·Z-0141-2014·2013-11-13

    Steris Harmony Equipment Management System Recalled for Drive Screw Failure Risk

    Steris Corporation is recalling 127 Harmony Equipment Management Systems because a drive screw in the ceiling supply unit may break, causing the adjustable arm to drop.

    Product
    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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2263-2013·2013-10-02

    Steris Reliance Endoscope Processing System Recalled for Air Pipe Defect

    Steris is recalling 266 Reliance Endoscope Processing Systems because an air pipe defect prevents forced flow during the disinfection cycle.

    Product
    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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1786-2013·2013-07-31

    Steris Recalls Fine Traction Devices Due to Bearing Defect

    Steris Corporation is recalling 16 units of Fine Traction Devices because a bearing failed pre-release reliability testing. The devices were distributed in five US states and Canada.

    Product
    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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1596-2013·2013-07-03

    STERIS Recalls Quick Connects for Labeling Updates

    STERIS Corporation is recalling four Quick Connect products to update labeling and remove obsolete device models.

    Product
    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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0915-2013·2013-03-13

    Steris Recalls Amsco Steam Sterilizers Due to Erroneous Alarm Activation

    Steris Corporation is recalling Amsco C and Amsco 400 steam sterilizers because control board defects cause erroneous alarms that lock up the devices.

    Product
    AMSCO C and AMSCO 400 Steam Sterilizers designed for sterilization of heat and moisture-stable materials used in healthcare facilities.
    Category
    Medical Device
    Distribution
    45 states
  • HighFDA (Devices)·Z-2402-2012·2012-09-26

    Steris Surgical Table Recalled for Potential Unintended Movement

    Steris Corporation is recalling 11,044 surgical tables because prohibited storage of objects on the base or column can damage the override switch, potentially causing the table to move without operator prompting.

    Product
    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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2426-2012·2012-09-26

    Steris Recalls 5085 Surgical Tables Due to Hydraulic Column Damage

    Steris is recalling 379 surgical tables because external impact damage to the hydraulic column can misalign shrouds and impede table movement.

    Product
    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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2417-2012·2012-09-26

    Steris Recalls Verify Bowie-Dick Test Cards Due to Performance Issues

    Steris Corporation is recalling Verify Bowie-Dick Test Cards because they may produce false fail results, potentially indicating sterilizer issues when performance is actually acceptable.

    Product
    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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2335-2012·2012-09-19

    Steris SYSTEM 1E Liquid Sterilant System Recalled for Hose Disconnection

    Steris Corporation is recalling 6,051 SYSTEM 1E Liquid Sterilant Processing Systems because the hose can disconnect when the unit is left on, causing water leakage and property damage.

    Product
    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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2325-2012·2012-09-12

    Steris recalls 77 packs of medical tubing due to failed process indicators

    Steris Corporation is recalling 77 packs of medical tubing that failed process indicators. The tubing is used to maintain the sterility of enclosed medical devices.

    Product
    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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2284-2012·2012-09-05

    Steris Recalls QKC1692E Quick Connect Devices Due to Labeling Errors

    Steris Corporation is recalling 64 QKC1692E Quick Connect devices because seven endoscope models were not validated for use with the device, requiring label corrections.

    Product
    QKC1692E The QKC1692E Quick Connect device connects endoscopes to the sterilization tray for C1220E liquid chemical sterilization processor.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2122-2012·2012-08-08

    Steris Reliance 130 Cart Washer Recall for Door Safety Feature Installation

    Steris is recalling 367 Reliance 130 and 130L Cart Washers to install a door close confirmation button and door open delay to ensure proper operation.

    Product
    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…
    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.