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.

26–50 of 122

  • ModerateFDA (Devices)·Z-0617-2024·2024-01-03

    Medivators Advantage Endoscope Hookup Accessories Recalled for Illegible Identification Labels

    Steris Corporation recalls Medivators Advantage endoscope hookup accessories because identification labels become illegible as ink degrades, potentially preventing proper hookup identification and delaying patient procedures.

    Product
    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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1595-2023·2023-05-24

    Steris Reliance Vision Washer/Disinfector Recalled for Fire and Smoke Risk

    Steris is recalling 322 Reliance Vision Multi-Chamber Washer/Disinfectors because an electrical contactor malfunction could cause heating elements to overheat and produce smoke or fire.

    Product
    Reliance Vision Multi-Chamber Washer/Disinfector, Reference Number FH83062
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1476-2023·2023-05-10

    Steris Light Handle Covers May Detach During Surgical Use

    Steris Corporation is recalling 263,280 surgical light handle covers worldwide because they may separate from the light handle during procedures, potentially compromising the sterile field.

    Product
    Steris Lighting and Visualization Systems, Sterile Light handle Cover LB44 -Sterilizable consumables (disposable, single use) used to drape the lighthandle of STERIS surgical lighting systems for the purpose of maintaining a sterile surgical environment. REF: LB44
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1475-2023·2023-05-10

    Steris surgical light handle covers may detach during procedures

    Steris surgical light handle covers may detach during use, risking contamination of the sterile field and patient injury. The FDA is recalling approximately 1.4 million affected covers.

    Product
    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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0781-2023·2023-01-11

    Steris VERIFY Steam Test Pack biological indicators show inconsistent performance

    Steris Corporation is recalling VERIFY Steam Test Pack biological indicators (lot #230613) due to inconsistent performance in promoting spore growth. When used to monitor sterilization, some indicators may not show growth even if the sterilization cycle was ineffective, creating false assurance of sterility.

    Product
    VERIFY Steam Test Pack (20 Tests and 20 controls) Item Number: S3069 Intended for use in installation testing and routine monitoring of steam and ethylene oxide sterilization processes
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0779-2023·2023-01-11

    Steris Biological Indicators Recalled for Inconsistent Spore Growth

    Steris Corporation is recalling VERIFY Dual Species Self-Contained Biological Indicators because some units in lot 230613 fail to consistently promote spore growth, potentially masking failed sterilization cycles.

    Product
    VERIFY Dual Species Self-Contained Biological Indicators, 100 per box Item Number: S3061 Intended for use in installation testing and routine monitoring of steam and ethylene oxide sterilization processes
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0778-2023·2023-01-11

    Steris Biological Indicator Lot May Fail to Detect Inadequate Sterilization

    Steris Corporation is recalling 338 boxes of VERIFY Dual Species Biological Indicators (Lot #230613) because some units fail to promote spore growth as intended, risking false-negative sterilization test results.

    Product
    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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0780-2023·2023-01-11

    VERIFY Steam Test Pack Biological Indicators May Fail to Detect Sterilization Failure

    Steris is recalling VERIFY Steam Test Packs because biological indicators in affected lots may fail to correctly monitor steam and ethylene oxide sterilization, potentially allowing failed sterilization to go undetected.

    Product
    VERIFY Steam Test Pack (20 Tests and 5 controls) Item Number: S3065 Intended for use in installation testing and routine monitoring of steam and ethylene oxide sterilization processes
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0241-2023·2022-11-23

    GI4000 Electrosurgical Unit recalled due to power regulator failure risk

    Steris recalls 5 GI4000 Electrosurgical Units with defective diode components that may cause power loss during endoscopic procedures.

    Product
    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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0079-2023·2022-10-19

    Scalpel Handle Recall: Hu-Friedy K360 Separates and Poses Choking Risk

    Hu-Friedy K360 scalpel handles may separate from the grip during use, allowing the tip to fall into a patient's mouth and cause cuts or choking.

    Product
    Hu-Friedy K360 Scalpel Handle, 360 Degree Scalpel Handle, REF K360
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-1256-2022·2022-06-15

    Reliance Synergy Washer/Disinfector fire hazard due to electrical contactor malfunction

    Steris Corporation is recalling Reliance Synergy Washer/Disinfector units due to a malfunctioning electrical contactor that can cause heating elements to overheat, creating a fire risk. Affected units may generate smoke and fire in the drying chamber.

    Product
    Reliance Synergy Washer/Disinfector
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1119-2022·2022-06-01

    Steris Non-Woven Sponges recalled; product not approved for US distribution

    Steris Corporation is recalling 152 cases of Ultra Pure Non-Woven Sponges because the product was not approved for release for US distribution.

    Product
    Ultra Pure Non-Woven Sponges Non-Sterile 4-Ply 2,000 per case 10 sleeves of 200 4 in x 4 in / 10.2 cm x 10.2 cm Model Number: ENC4100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1118-2022·2022-06-01

    Steris Recalls Ultra Pure Non-Woven Sponges for Unapproved Distribution

    Steris Corporation is recalling 103 cases of Ultra Pure Non-Woven Sponges (Lot 202108) distributed nationwide because the product was released without FDA approval. Customers should discontinue use and contact the manufacturer.

    Product
    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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0876-2021·2021-01-27

    Steris Reliance Vision Washer/Disinfector Recalled for Fire Risk

    Steris is recalling Reliance Vision Single-Chamber Washer/Disinfector units because a faulty electrical contactor may cause the drying chamber to overheat, potentially leading to smoke or fire.

    Product
    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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0830-2021·2021-01-20

    Steris Recalls Medisafe Distal Duck Kits Due to Bacteria Presence

    Steris is recalling specific lots of Medisafe Distal Duck Kits and Bags because they may contain Pseudomonas fluorescens bacteria. The agency notes there is no risk to patients.

    Product
    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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0792-2021·2021-01-13

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

    Steris Corporation is recalling Vis-U-All High Temp Heat Seal Pouches because purple ink on the exterior label may bleed after steam processing, causing cosmetic defects and potential ink transfer to devices.

    Product
    Vis-U-All High Temp 7.5"x13.5" Heat Seal Pouch 200 pouches per box; 5 boxes per case Model Number: 883713
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0788-2021·2021-01-13

    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 outside label may bleed during steam processing, causing cosmetic defects and potential ink transfer to devices.

    Product
    Vis-U-All High Temperature Tubing 6"x100'. One roll per box; 10 boxes per case 10 rolls/cs Model Number: 881061
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0786-2021·2021-01-13

    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 bleed during steam processing, causing cosmetic defects and potential ink transfer to devices.

    Product
    Vis-U-All High Temperature Tubing 3"x100'. One roll per box; 10 boxes per case 10 rolls/cs Model Number: 881031
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0793-2021·2021-01-13

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

    Steris Corporation is recalling Vis-U-All High Temp Self Seal Pouches because purple ink on the exterior label may bleed during steam processing.

    Product
    Vis-U-All High Temp 3.5"x9" Self Seal Pouch 200 pouches per box; 4 boxes per case Model Number: 884039
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0790-2021·2021-01-13

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

    Steris Corporation is recalling Vis-U-All High Temp Heat Seal Pouches because purple ink on the exterior label may bleed during steam processing, causing cosmetic defects and potential ink transfer to devices inside.

    Product
    Vis-U-All High Temp 4.5"x11" Heat Seal Pouch 200 pouches per box; 5 boxes per case Model Number: 883411
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0795-2021·2021-01-13

    Steris Vis-U-All Pouches Recalled for Ink Migration Defect

    Steris Corporation is recalling Vis-U-All High Temp Self Seal Pouches because purple ink on the exterior label may bleed during steam processing.

    Product
    Vis-U-All High Temp 4"x11" Self Seal Pouch 200 pouches per box; 4 boxes per case Model Number: 884411
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0787-2021·2021-01-13

    Steris Vis-U-All High Temperature Tubing Recalled for Ink Migration

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

    Product
    Vis-U-All High Temperature Tubing 4"x100'. One roll per box; 10 boxes per case 10 rolls/cs Model Number: 881041
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0799-2021·2021-01-13

    Steris Vis-U-All Pouches Recalled for Ink Migration on Exterior Labels

    Steris Corporation is recalling Vis-U-All High Temp Self Seal Pouches because purple ink on the exterior label may bleed during steam processing, causing cosmetic defects or ink transfer to devices.

    Product
    Vis-U-All High Temp 8"x16" Self Seal Pouch 200 pouches per box; 4 boxes per case Model Number: 884816
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0794-2021·2021-01-13

    Steris Vis-U-All Pouches Recalled for Ink Migration

    Steris Corporation is recalling Vis-U-All High Temp Self Seal 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 13"x18" Self Seal Pouch 100 pouches per box; 4 boxes per case Model Number: 884118
    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.