FDA Device Recalls

Recalls / Firms / Steris Corporation

Steris Corporation

126 FDA device recalls on record.

DateClassProductReason
2025-11-19—AMSCO 7053HP Washer/Disinfector Model/Catalog Number: 7053HP Product Description: The AMSCO 7053H
2025-11-19—AMSCO 7052HP Washer/Disinfector Model/Catalog Number: 7052HP Product Description: The AMSCO 7052HP
2025-06-23—Dual Flat Panel Monitor (DFPM) accessories for HarmonyAIR A-Series Surgical Lighting Systems
2025-06-23—Dual Flat Panel Monitor (DFPM) accessories for HarmonyAIR E-Series Surgical Lighting Systems
2025-05-23—Barco MNA with the HexaVue IP Integration System, Model/Catalog Number: MNA-6x0-H
2024-06-13—Hookup Model/Catalog Number: 2-8-540HAN Product Description: Hookups provide the interface between
2024-06-13—Hookup Model/Catalog Number: 2-8-540CAS Product Description: Hookups provide the interface between
2024-06-13—Hookup Model/Catalog Number: DSD-110-HU0163 Product Description: Hookups provide the interface betw
2024-06-13—Hookup Model/Catalog Number: 2-8-540 Product Description: Hookups provide the interface between an
2023-12-12—Dual Articulating Headrest, Velcro P/N P141210813, REF BF753
2023-12-12—Dual Articulating Headrest, Pad Ret P/N P141210805, REF BF754
2023-11-16—V. Mueller Universal Bandage Scissors Black Plastic Handles Heavy-Duty, Autoclavable, Overall Length
2023-11-13—Hookup Accessories used with MEDIVATORS ADVANTAGE PLUS and ADVANTAGE PLUS Pass Thru Automated Endosc
2023-04-10—Reliance Vision Multi-Chamber Washer/Disinfector, Reference Number FH83062
2023-03-17—Steris Lighting and Visualization Systems, Sterile Light Handle Cover (LB53)- Surgical light handle
2023-03-17—Steris Lighting and Visualization Systems, Sterile Light handle Cover LB44 -Sterilizable consumabl
2022-12-12—VERIFY Dual Species Self-Contained Biological Indicators, 100 per box Item Number: S3061 Intended f
2022-12-12—VERIFY Dual Species Self-Contained Biological Indicators, 50 per box Item Number: S3060 Intended fo
2022-12-12—VERIFY Steam Test Pack (20 Tests and 5 controls) Item Number: S3065 Intended for use in installatio
2022-12-12—VERIFY Steam Test Pack (20 Tests and 20 controls) Item Number: S3069 Intended for use in installati
2022-10-17—GI4000 Electrosurgical Unit - intended to deliver electrosurgical outputs to perform cutting and/or
2022-09-02—Hu-Friedy K360 Scalpel Handle, 360 Degree Scalpel Handle, REF K360
2022-04-22—Reliance Synergy Washer/Disinfector
2022-03-22—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
2022-03-22—Ultra Pure Non-Woven Sponges Non-Sterile 4-Ply 2,000 per case 10 sleeves of 200 4 in x 4 in / 10.2 c
2021-01-21—OT1000 Series Orthopedic Surgical Tables
2020-12-11—Reliance Vision Single-Chamber Washer/Disinfector - Product Usage: intended for use in the cleaning
2020-12-02—Vis-U-All High Temp 4.5"x11" Heat Seal Pouch 200 pouches per box; 5 boxes per case Model Number:
2020-12-02—Vis-U-All High Temperature Tubing 4"x100'. One roll per box; 10 boxes per case 10 rolls/cs Model Nu
2020-12-02—Vis-U-All High Temperature Tubing 3"x100'. One roll per box; 10 boxes per case 10 rolls/cs Model Num
2020-12-02—Vis-U-All High Temp 7.5"x13.5" Heat Seal Pouch 200 pouches per box; 5 boxes per case Model Numbe
2020-12-02—Vis-U-All High Temp 6"x10" Heat Seal Pouch 200 pouches per box; 5 boxes per case Model Number: 88
2020-12-02—Vis-U-All High Temp 5"x15" Self Seal Pouch 200 pouches per box; 4 boxes per case Model Number
2020-12-02—Vis-U-All High Temp 13"x18" Self Seal Pouch 100 pouches per box; 4 boxes per case Model Number:
2020-12-02—Vis-U-All High Temp 8"x16" Self Seal Pouch 200 pouches per box; 4 boxes per case Model Numbe
2020-12-02—Vis-U-All High Temp 7.5"x13" Self Seal Pouch 200 pouches per box; 4 boxes per case Model Num
2020-12-02—Vis-U-All High Temp 4"x11" Self Seal Pouch 200 pouches per box; 4 boxes per case Model Number:
2020-12-02—Vis-U-All High Temperature Tubing 9"x100'. One roll per box; 10 boxes per case 6 rolls/cs Model Nu
2020-12-02—Vis-U-All High Temp 3.5"x9" Self Seal Pouch 200 pouches per box; 4 boxes per case Model Number:
2020-12-02—Vis-U-All High Temp 5.5"x10" Self Seal Pouch 200 pouches per box; 4 boxes per case Model Numbe
2020-12-02—Vis-U-All High Temperature Tubing 6"x100'. One roll per box; 10 boxes per case 10 rolls/cs Model Nu
2020-11-19—Medisafe Distal Duck Kit and Duck Bag, Cleaner, ultrasonic, medical instrument - Product Usage: inte
2020-10-07—Olympus Leak Test Adapter used with Acu-sInQ Complete Endoscope Cleaning Aid Systems-intended to ass
2020-06-26—InnoWave Sonic Irrigator, There are currently six models (PCF, Pro, Ultra, Ultra+, Unity, and ECO) -
2019-10-22—Evolution Loading Car and Transfer Carriage- Accessory to the Sterilizer, Steam
2019-10-22—Eagle 3000 Sterilizer, small steam sterilizer. Product Usage: The Eagle 3000 Small Sterilizer is des
2018-12-26—ATLAS Loading Car
2018-12-20—AMSCO 5000 Series Washer/Disinfector Model # 5052
2018-12-20—AMSCO 3000 Series Washer/Disinfector Model # 3052
2018-07-26—AMSCO V-PRO 1, V-PRO 1 Plus, and V-PRO maX Low Temperature Sterilization Systems The V-PRO 1, V-PR
2018-05-23—Reliance 1227 Cart and Utensil Washer/Disinfector, FW03101, FW03102, FW03S003 Product Usage: The Re
2017-09-28—V-PRO 60 Low Temperature Sterilization System (UDI: 00724995152000)
2017-06-15—Vis-U-All High Temp 4"x11" Self Seal Pouch 200 pouches per box; 4 boxes per case Product Usage: The
2017-06-15—Vis-U-All High Temp 7.5"x13" Self Seal Pouch 200 pouches per box; 4 boxes per case Product Usage: T
2017-06-15—Vis-U-All High Temp 4"x8" Heat Seal Pouch 200 pouches per box; 5 boxes per case Product Usage: The
2017-06-15—Vis-U-All High Temp 16"x16" Self Seal Pouch 100 pouches per box; 6 boxes per case Product Usage: Th
2017-06-15—Vis-U-All High Temp 5"x15" Heat Seal Pouch 200 pouches per box; 4 boxes per case Product Usage: The
2017-06-15—Vis-U-All High Temp 3.5"x22" Heat Seal Pouch 200 pouches per box; 5 boxes per case Product Usage: T
2017-06-15—Vis-U-All High Temp 3"x8" Heat Seal Pouch 200 pouches per box; 5 boxes per case Product Usage: The
2017-06-15—Vis-U-All High Temp 5"x15" Self Seal Pouch 200 pouches per box; 4 boxes per case Product Usage: The
2017-06-15—Vis-U-All High Temperature Tubing 4"x100'. One roll per box; 10 boxes per case 10 rolls/cs Product
2017-06-15—Vis-U-All High Temperature Tubing 14"x100'. One roll per box; 10 boxes per case 6 rolls/cs Product
2017-06-15—Vis-U-All High Temp 10.5"x28" Self Seal Pouch 100 pouches per box; 4 boxes per case Product Usage:
2017-06-15—Vis-U-All High Temp 18"x22" Heat Seal Pouch 100 pouches per box; 5 boxes per case Product Usage: Th
2017-06-15—Vis-U-All High Temp 13"x18" Heat Seal Pouch 100 pouches per box; 4 boxes per case Product Usage: Th
2017-06-15—Vis-U-All High Temp 18"x22" Self Seal Pouch 100 pouches per box; 5 boxes per case Product Usage: Th
2017-06-15—Vis-U-All High Temp 10"x15" Heat Seal Pouch 100 pouches per box; 5 boxes per case Product Usage: Th
2017-06-15—Vis-U-All High Temp 7.5"x13" Self Seal Pouch 200 pouches per box; 4 boxes per case Product Usage: T
2017-06-15—Vis-U-All High Temp 6"x10" Heat Seal Pouch 200 pouches per box; 5 boxes per case Product Usage: The
2017-06-15—Vis-U-All High Temp 8"x10" Heat Seal Pouch 200 pouches per box; 5 boxes per case Product Usage: The
2017-06-15—Vis-U-All High Temp 4.5"x11" Heat Seal Pouch 200 pouches per box; 5 boxes per case Product Usage: T
2017-06-15—Vis-U-All High Temperature Tubing 6"x100'. One roll per box; 10 boxes per case 10 rolls/cs Product U
2017-06-15—Vis-U-All High Temp 3.5"x9" Self Seal Pouch 200 pouches per box; 4 boxes per case Product Usage: Th
2017-06-15—Vis-U-All High Temp 3.5"x22" Self Seal Pouch 200 pouches per box; 4 boxes per case Product Usage: T
2017-06-15—Vis-U-All High Temperature Tubing 9"x100'. One roll per box; 10 boxes per case 6 rolls/cs Product U
2017-06-15—Vis-U-All High Temp 13"x18" Self Seal Pouch 100 pouches per box; 4 boxes per case Product Usage: Th
2017-06-15—Vis-U-All High Temp 7.5"x13.5" Heat Seal Pouch 200 pouches per box; 5 boxes per case Product Usage:
2017-06-15—Vis-U-All High Temp 5.5"x10" Self Seal Pouch 200 pouches per box; 4 boxes per case Product Usage: T
2017-06-15—Vis-U-All High Temp 16"x16" Heat Seal Pouch 100 pouches per box; 5 boxes per case Product Usage: Th
2017-06-15—Vis-U-All High Temp 8"x16" Self Seal Pouch 200 pouches per box; 4 boxes per case Product Usage: The
2017-06-15—Vis-U-All High Temp 8"x16" Heat Seal Pouch 100 pouches per box; 9 boxes per case Product Usage: The
2016-10-05—Harmony Insight Diagnostic Monitor Support System - 100 Spring Arm (EMS) The system is intended for
2016-05-23—OT1000 Series Orthopedic Surgical Tables
2015-12-04—Quick Connects. Steris Corporation. Model numbers: QKC1736E, QKC1736INT, QKC1737E, and QKC1737INT.
2015-11-20—AMSCO Warming Cabinet. Manufactured by: STERIS Corporation To raise the temperature of blankets, l
2015-09-03—AMSCO 400 and AMSCO C Small Steam Sterilizers
2015-02-19—AMSCO C and AMSCO 400 Steam Sterilizers, STERIS Corporation. AMSCO C Small Sterilizer, AMSCO 400 Sm
2015-02-19—Caviwave Pro Ultrasonic Cleaning System, Product Usage: To wash (remove tissue, blood and other co
2014-11-26—Harmony vLED Surgical Lighting System, one unit packaged per box The Harmony vLED Surgical Lighting
2014-10-10—The 5085 is a general surgical table with high patient weight capacity, extended width capability, a
2014-06-30—Reliance 1227 Cart and Utensil Washer/Disinfector Product Usage: Usage: The Reliance 1227 Cart and
2014-06-27—The STERIS 4085 General Surgical Table Product Usage: is an electro-hydraulically operated surgica
2014-04-04—Vertical Spring Arm for Single or Dual Monitor Mount (Harmony LL 500 and Harmony LL 700 surgical lig
2013-12-19—VERIFY SixCess 270FP Challenge Pack, STERIS Corporation, 5960 Heisley Road, Mentor, OH 44060, 440-35
2013-11-21—SYSTEM 1E Liquid Chemical Sterilant Processing System, Distributed by STERIS Corporation, Mentor, OH
2013-10-18—AMSCO Evolution steam sterilizer Transfer Carriage. Product Usage: Mobile, wheeled transportation
2013-09-10—VERIFY Dual Species Self-Contained Biological Indicator, Distributed by STERIS Corporation, Mentor,
2013-08-29—Reliance Endoscope Processing System (REPS), STERIS Corporation, 5960 Heisley Road, Mentor, OH 44060
2013-08-15—Harmony Equipment Management System, Model #603X/80XX, STERIS Corporation, Mentor, OH Harmony Equip
2013-05-20—STERIS Fine Traction Device, one unit per box Product Usage: The Fine Traction Device is used to pr
2013-03-04—Quick Connect QLC1677E, QRC1699E, QPC1721E and QFC1683E. STERIS Corporation, Mentor, OH 44060 QLC16
2013-02-12—AMSCO C and AMSCO 400 Steam Sterilizers designed for sterilization of heat and moisture-stable mater
2012-08-10—QKC1692E The QKC1692E Quick Connect device connects endoscopes to the sterilization tray for C1220
2012-08-02—100 ft roll of tubing inside a cardboard box. Medical devices are sealed into the tubes prior to eth
2012-08-01—The SYSTEM 1E Liquid Sterilant Processing System. The SYSTEM 1E Liquid Sterilant Processing System
2012-07-14—The Reliance 130 and 130L Cart Washer/Disinfector is a high capacity mechanical washer intended for
2012-07-03—Verify Bowie-Dick Test Card, Model #S3098, Steris Biological Operations, 9325 Pinecone Drive, Mentor
2012-04-06—STERIS 5085 and 5085 SRT Surgical Tables, Product Usage: The 5085 is a general surgical table wit
2012-03-23—The Evolution steam sterilizers, manufactured by Steris Corporation, utilize a loading system to ass
2011-10-17—STERIS 5085 and 5085SRT Surgical Tables, Catalog Numbers: 5085- ST01-410-1; 5085SRT- ST0-1420-6.
2011-08-11—SYSTEM 1E Liquid Chemical Sterilant Processing System, Model # P6500, S/N: 400001 through 405005; Mf
2011-08-01—Amsco V-PRO 1 and Amsco V-PRO 1 Plus Low Temperature Sterilization Systems Model #MLR, Serial # 0332
2011-05-09—Reliance Vision Single Chamber Washer/Disinfector, Model # 1802983, The Vision Single Chamber Washe
2011-03-16—Verify SixCess Challenge Pack, Model #'s: LCC003, LCC005, LCC014 & LCC310, Mfr. By: Albert Browne,
2011-03-16—Verify SixCess Indicator Strips, Model #: PCC005, PCC006, PCC007, PCC008, PCC031, PCC033, PCC034, PC
2011-02-18—Harmony LA/LED Monitor Arm Adapter. Model Number: LB61 The Harmony LA/LED Monitor Arm Adapter is an
2010-08-12—Cmax Surgical Tables, Model #'s: Cmax110, Cmax 220 manufactured by Steris Corporation in Montgomery,
2010-07-02—Steris Reliance EPS Endoscope Processing System , manufactured by Corporation STERIS Canada, Quebec,
2010-05-14—STERIS 4085, 5085 & 5085SRT Surgical Tables
2010-02-23—Harmony Lux Advantage LA Surgical Lighting and Visualization System, also known as the Harmony LA 50
2010-02-23—Harmony Lux Classic, Surgical Lighting System, also known as the Harmony LC 500, B129388085 and B129
2010-02-23—Harmony Lux Advantage LA Surgical Lighting and Visualization System, also known as the Harmony LA 70
2010-02-17—A mobile, electro-hydraulically operated, fluoroscopic/C-Arm compatible general surgical table. P
2007-02-06—Cmax Surgical Table, Model No. 2182625, Manufactured by STERIS Corporation, 2720 Gunter Park East, M
2006-06-22—Amsco Sonic Energy Console, Part Nos.: B602047470, P080000002, P080000003, B018905015, B018905016,
2006-06-22—Steris Amsco Sonic Energy Cleaner, Part Nos.: P080000005, B018905020, B018905JBJ, and B018905JBJSS