Steris Corporation

Complete recall history across all FDA and CPSC categories, 109 total recalls

Steris Corporation appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (109)

FDA medical device enforcement actions by Steris Corporation. Showing most recent 50.

Date Product Reason Class
Sep 23, 2026 HexaVue Focus Integration System, a single, all-in-one system that handles op... A software issue may result in unintended mismatch of patient information on ... Class II
Sep 21, 2026 RAPICIDE PA Part A High-Level Disinfectant, Model/Catalog Number: ML020116 If the vented cap becomes blocked, gas may accumulate and the bottle may swe... Class II
Sep 21, 2026 RAPICIDE PA Part A High-Level Disinfectant, Model/Catalog Number: ML020117 If the vented cap becomes blocked, gas may accumulate and the bottle may swe... Class II
Sep 21, 2026 RAPICIDE PA Part A High-Level Disinfectant, Model/Catalog Number: ML020115 If the vented cap becomes blocked, gas may accumulate and the bottle may swe... Class II
Aug 31, 2026 VERIFY Biological Steam Test Pack Model/Catalog Number: S3069 Geobacillus stearothermophilus spore population in affected products may fall... Class II
Aug 31, 2026 VERIFY Biological/Integrator Challenge Pack Model/Catalog Number: LCB007 Geobacillus stearothermophilus spore population in affected products may fall... Class II
Aug 31, 2026 VERIFY Dual Species Self-Contained Biological Indicator Model/Catalog Numb... Geobacillus stearothermophilus spore population in affected products may fall... Class II
Aug 31, 2026 VERIFY Dual Species Self-Contained Biological Indicator Model/Catalog Number... Geobacillus stearothermophilus spore population in affected products may fall... Class II
Aug 31, 2026 VERIFY Biological/Integrator Challenge Pack Model/Catalog Number: LCB006 Geobacillus stearothermophilus spore population in affected products may fall... Class II
Aug 31, 2026 VERIFY Biological Steam Test Pack Model/Catalog Number: S3065 Geobacillus stearothermophilus spore population in affected products may fall... Class II
May 15, 2026 ALYON Surgical Lighting System The the plus and minus buttons (+/-) used to control light intensity on the l... Class II
May 15, 2026 HarmonyAIR A-Series Surgical Lighting System There is a potential for paint delamination (chipping/peeling) on the lightin... Class II
May 15, 2026 HarmonyAIR A-Series Surgical Lighting System The the plus and minus buttons (+/-) used to control light intensity on the l... Class II
Nov 19, 2025 AMSCO 7053HP Washer/Disinfector Model/Catalog Number: 7053HP Product De... Wire connected to the electrical box may shift out of its intended position, ... Class II
Nov 19, 2025 AMSCO 7052HP Washer/Disinfector Model/Catalog Number: 7052HP Product Des... Wire connected to the electrical box may shift out of its intended position, ... Class II
Jun 23, 2025 Dual Flat Panel Monitor (DFPM) accessories for HarmonyAIR A-Series Surgical L... The DFPM yoke assembly ("yoke assembly") may detach from the spring arm. Shou... Class II
Jun 23, 2025 Dual Flat Panel Monitor (DFPM) accessories for HarmonyAIR E-Series Surgical L... The DFPM yoke assembly ("yoke assembly") may detach from the spring arm. Shou... Class II
May 23, 2025 Barco MNA with the HexaVue IP Integration System, Model/Catalog Number: MNA-6... This is a sub-recall of event RES 96885. The supplier identified that during ... Class II
Jun 13, 2024 Hookup Model/Catalog Number: DSD-110-HU0163 Product Description: Hookups ... IFU for hookup were incorrectly reflected within hookup IFUs and online refer... Class II
Jun 13, 2024 Hookup Model/Catalog Number: 2-8-540HAN Product Description: Hookups prov... IFU for hookup were incorrectly reflected within hookup IFUs and online refer... Class II
Jun 13, 2024 Hookup Model/Catalog Number: 2-8-540 Product Description: Hookups provide... IFU for hookup were incorrectly reflected within hookup IFUs and online refer... Class II
Jun 13, 2024 Hookup Model/Catalog Number: 2-8-540CAS Product Description: Hookups prov... IFU for hookup were incorrectly reflected within hookup IFUs and online refer... Class II
Dec 12, 2023 Dual Articulating Headrest, Velcro P/N P141210813, REF BF753 Dual-articulating head rest may not stay in place or may fail to lock into po... Class II
Dec 12, 2023 Dual Articulating Headrest, Pad Ret P/N P141210805, REF BF754 Dual-articulating head rest may not stay in place or may fail to lock into po... Class II
Nov 16, 2023 V. Mueller Universal Bandage Scissors Black Plastic Handles Heavy-Duty, Autoc... Bandage Scissors handle cover component contains an incorrect color masterbat... Class II
Nov 13, 2023 Hookup Accessories used with MEDIVATORS ADVANTAGE PLUS and ADVANTAGE PLUS Pa... Identification label on affected hookups could become illegible over time due... Class II
Apr 10, 2023 Reliance Vision Multi-Chamber Washer/Disinfector, Reference Number FH83062 In the remote occurrence in which the electrical contactor component present ... Class II
Mar 17, 2023 Steris Lighting and Visualization Systems, Sterile Light handle Cover LB44 ... Light handle covers may separate from the light handle (detach and fall off) ... Class II
Mar 17, 2023 Steris Lighting and Visualization Systems, Sterile Light Handle Cover (LB53)-... Light handle covers may separate from the light handle (detach and fall off) ... Class II
Dec 12, 2022 VERIFY Dual Species Self-Contained Biological Indicators, 50 per box Item Nu... Biological indicator (BI) used to promote growth of the G. stearothermophilus... Class II
Dec 12, 2022 VERIFY Steam Test Pack (20 Tests and 5 controls) Item Number: S3065 Inten... Biological indicator (BI) used to promote growth of the G. stearothermophilus... Class II
Dec 12, 2022 VERIFY Dual Species Self-Contained Biological Indicators, 100 per box Item N... Biological indicator (BI) used to promote growth of the G. stearothermophilus... Class II
Dec 12, 2022 VERIFY Steam Test Pack (20 Tests and 20 controls) Item Number: S3069 Inte... Biological indicator (BI) used to promote growth of the G. stearothermophilus... Class II
Oct 17, 2022 GI4000 Electrosurgical Unit - intended to deliver electrosurgical outputs to ... Two electronic diode components (D1 & D4) placed in the reverse orientation o... Class II
Sep 2, 2022 Hu-Friedy K360 Scalpel Handle, 360 Degree Scalpel Handle, REF K360 The scalpel holder may separate from the handle for certain lots. If the tip ... Class II
Apr 22, 2022 Reliance Synergy Washer/Disinfector The firm identified that when the electrical contactor component in the dryin... Class II
Mar 22, 2022 Ultra Pure Non-Woven Sponges Non-Sterile 4-Ply 2,000 per case 10 sleeves of 2... Product not approved for release for US distribution Class II
Mar 22, 2022 Ultra Pure Non-Woven Sponges Non-Sterile 4-Ply 5,000 per case 25 sleeves of 2... Product not approved for release for US distribution Class II
Jan 21, 2021 OT1000 Series Orthopedic Surgical Tables On January 7, 2021, STERIS identified that the glued bond between the beam an... Class II
Dec 11, 2020 Reliance Vision Single-Chamber Washer/Disinfector - Product Usage: intended f... The electrical contactor component present in the drying chamber of the Relia... Class II
Dec 2, 2020 Vis-U-All High Temperature Tubing 4"x100'. One roll per box; 10 boxes per cas... Purple ink located on the outside label of Vis-U-All Pouches may migrate (ble... Class II
Dec 2, 2020 Vis-U-All High Temperature Tubing 3"x100'. One roll per box; 10 boxes per cas... Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bl... Class II
Dec 2, 2020 Vis-U-All High Temp 4.5"x11" Heat Seal Pouch 200 pouches per box; 5 boxes per... Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bl... Class II
Dec 2, 2020 Vis-U-All High Temp 7.5"x13" Self Seal Pouch 200 pouches per box; 4 boxes per... Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bl... Class II
Dec 2, 2020 Vis-U-All High Temp 8"x16" Self Seal Pouch 200 pouches per box; 4 boxes per c... Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bl... Class II
Dec 2, 2020 Vis-U-All High Temp 5"x15" Self Seal Pouch 200 pouches per box; 4 boxes per c... Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bl... Class II
Dec 2, 2020 Vis-U-All High Temp 4"x11" Self Seal Pouch 200 pouches per box; 4 boxes per c... Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bl... Class II
Dec 2, 2020 Vis-U-All High Temp 5.5"x10" Self Seal Pouch 200 pouches per box; 4 boxes per... Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bl... Class II
Dec 2, 2020 Vis-U-All High Temperature Tubing 6"x100'. One roll per box; 10 boxes per cas... Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bl... Class II
Dec 2, 2020 Vis-U-All High Temp 6"x10" Heat Seal Pouch 200 pouches per box; 5 boxes per c... Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bl... Class II

View all 109 device recalls →

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious, there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious, the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

Yes. You can search for any company using the firm/manufacturer pages for each category: Food Firms, Drug Firms, Device Firms, or Product Manufacturers. You can also use the search functionality on any browse page to find recalls by company name.

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