Mentor, OH, United States
Steris Corporation recalls
33 recalls recorded since 2018, most recently on 23 September 2026. 15 are listed as ongoing. Status and classification are as published by the FDA.
Recalls33
Ongoing (FDA)15
Terminated or completed18
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 23 September 2026
- Reason
- A software issue may result in unintended mismatch of patient information on manually printed images. Incorrect patient information appearing on printed images could create a documentation discrepancy or incorrect association of clinical images with a patient record.
- Distribution
- Worldwide - US Nationwide and the countries of Australia, Canada, New Zealand.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0118-2027
- HexaVue Focus Integration System, a single, all-in-one system that handles operating room video routing, surgical video integration, and environmental control, Software Version: 2.0.18
Ongoing Class II Medical devices
- Recall started
- 21 September 2026
- Reason
- If the vented cap becomes blocked, gas may accumulate and the bottle may swell due to increased internal pressure. In some cases, excess vapor or liquid chemistry may escape from the bottle when the cap is twisted during opening, which could result in user exposure if required personal protective equipment (PPE) is not properly used. Such exposure may result in injury to the user or others in close proximity.
- Distribution
- Worldwide - US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0154-2027, Z-0156-2027, Z-0155-2027
- RAPICIDE PA Part A High-Level Disinfectant, Model/Catalog Number: ML020115
- RAPICIDE PA Part A High-Level Disinfectant, Model/Catalog Number: ML020117
- RAPICIDE PA Part A High-Level Disinfectant, Model/Catalog Number: ML020116
Ongoing Class II Medical devices
- Recall started
- 31 August 2026
- Reason
- Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization cycles, the potential hazard is that the biological indicator will show no growth, indicating that the steam cycle was effective, even if the steam cycle did not achieve the intended spore reduction
- Distribution
- Worldwide - US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0074-2027, Z-0070-2027, Z-0073-2027, Z-0072-2027, Z-0071-2027, Z-0075-2027
- VERIFY Biological Steam Test Pack Model/Catalog Number: S3065
- VERIFY Biological/Integrator Challenge Pack Model/Catalog Number: LCB006
- VERIFY Dual Species Self-Contained Biological Indicator Model/Catalog Number: S3061
- VERIFY Dual Species Self-Contained Biological Indicator Model/Catalog Number: S3060
- VERIFY Biological/Integrator Challenge Pack Model/Catalog Number: LCB007
- VERIFY Biological Steam Test Pack Model/Catalog Number: S3069
Ongoing Class II Medical devices
- Recall started
- 15 May 2026
- Reason
- The the plus and minus buttons (+/-) used to control light intensity on the light heads may detach.
- Distribution
- Worldwide - US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2449-2026, Z-2450-2026
- HarmonyAIR A-Series Surgical Lighting System
- ALYON Surgical Lighting System
Ongoing Class II Medical devices
- Recall started
- 15 May 2026
- Reason
- There is a potential for paint delamination (chipping/peeling) on the lighting system's light heads.
- Distribution
- Worldwide distribution - US Nationwide and the countries of Australia, Canada, India, New Zealand, Panama.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2448-2026
- HarmonyAIR A-Series Surgical Lighting System
Ongoing Class II Medical devices
- Recall started
- 19 November 2025
- Reason
- Wire connected to the electrical box may shift out of its intended position, which may result in electrical arcing. Electrical arcing remains internal within the unit (no risk of shock to users).
- Distribution
- Worldwide - US Nationwide distribution in the states of Arizona, Colorado, Florida, Georgia, Illinois, Kentucky, Louisiana, Michigan, New Hampshire, New York, North Carolina, Pennsylvania, Tennessee, Texas, Utah, Victoria, Virginia, Washington, Wisconsin and the countries of Australia.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0909-2026, Z-0910-2026
- AMSCO 7052HP Washer/Disinfector Model/Catalog Number: 7052HP Product Description: The AMSCO 7052HP Washer/Disinfector is intended for use in the cleaning and intermediate-level disinfection of soiled reusable simple
- AMSCO 7053HP Washer/Disinfector Model/Catalog Number: 7053HP Product Description: The AMSCO 7053HP Washer/Disinfector is intended for use in the cleaning and intermediate-level disinfection of soiled reusable simpl
Ongoing Class II Medical devices
- Recall started
- 23 June 2025
- Reason
- The DFPM yoke assembly ("yoke assembly") may detach from the spring arm. Should the yoke assembly detach from the spring arm, the yoke assembly would not be expected to fully detach but rather hang from the wiring within the yoke assembly.
- Distribution
- Worldwide - US Nationwide and Puerto Rico and the country of Canada.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2178-2025, Z-2177-2025
- Dual Flat Panel Monitor (DFPM) accessories for HarmonyAIR E-Series Surgical Lighting Systems
- Dual Flat Panel Monitor (DFPM) accessories for HarmonyAIR A-Series Surgical Lighting Systems
Ongoing Class II Medical devices
- Recall started
- 23 May 2025
- Reason
- This is a sub-recall of event RES 96885. The supplier identified that during their manufacturing process for a limited batch of MNA-6x0 (adapter) components the incorrect configuration file was used.
- Distribution
- US Nationwide distribution in the states of FL, NC, NY, OH, TN, TX, and VA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1361-2026
- Barco MNA with the HexaVue IP Integration System, Model/Catalog Number: MNA-6x0-H
Ongoing Class II Medical devices
- Recall started
- 13 June 2024
- Reason
- IFU for hookup were incorrectly reflected within hookup IFUs and online reference system, Hookup Lookup (HULU). Use of an incorrect hookup connection and/or parameter set may prevent an endoscope from being properly disinfected, which may present a risk of patient contamination or infection
- Distribution
- Worldwide distribution - United States Nationwide and the countries of Canada, Belgium, Czech Republic, Denmark, Germany, Spain, Italy, Slovenia, Slovakia, Australia, Israel, Jordan, Kuwait, Namibia, Saudi Arabia, South Africa, Cote d Ivoire, Afghanistan, Albania, Belarus, Botswana, Kazakhstan, Mala
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2538-2024, Z-2536-2024, Z-2537-2024, Z-2539-2024
- Hookup Model/Catalog Number: 2-8-540CAS Product Description: Hookups provide the interface between an Advantage Plus" Automated Endoscope Reprocessor and Advantage Plus" Pass-Thru Automated Endoscope Reprocessor ( AE
- Hookup Model/Catalog Number: 2-8-540 Product Description: Hookups provide the interface between an Advantage Plus" Automated Endoscope Reprocessor and Advantage Plus" Pass-Thru Automated Endoscope Reprocessor ( AER )
- Hookup Model/Catalog Number: 2-8-540HAN Product Description: Hookups provide the interface between an Advantage Plus" Automated Endoscope Reprocessor and Advantage Plus" Pass-Thru Automated Endoscope Reprocessor ( AE
- Hookup Model/Catalog Number: DSD-110-HU0163 Product Description: Hookups provide the interface between DSD Automated Endoscope Reprocessors ( AER ) and endoscopes, which allow perfusion of liquids dispensed by the AE
Ongoing Class II Medical devices
- Recall started
- 12 December 2023
- Reason
- Dual-articulating head rest may not stay in place or may fail to lock into position during a patient procedure which could result in an injury to the patient or a procedural delay.
- Distribution
- Worldwide - US Nationwide distribution in the states of AZ, CA, FL, IL, IN, IA, KS, LA, MN, MS, NV, NJ, OH, OK, OR, PA, TN, TX, UT, WA, WI & Puerto Rico, and the countries of Australia, Canada, Mexico & New Zealand.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0983-2024, Z-0984-2024
- Dual Articulating Headrest, Pad Ret P/N P141210805, REF BF754
- Dual Articulating Headrest, Velcro P/N P141210813, REF BF753
Ongoing Class II Medical devices
- Recall started
- 16 November 2023
- Reason
- Bandage Scissors handle cover component contains an incorrect color masterbatch resin carrier. This may allow a pink dye/residue to appear on the Bandage Scissors and/or sterilization pouches after processing.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0737-2024
- V. Mueller Universal Bandage Scissors Black Plastic Handles Heavy-Duty, Autoclavable, Overall Length 7 (18 cm)- Intended to cut through tape and bandages Model: SU2014-001
Ongoing Class II Medical devices
- Recall started
- 13 November 2023
- Reason
- Identification label on affected hookups could become illegible over time due to the label's ink coming off. This may potentially prevent users from being able to effectively identify the hookup and may ultimately result in postponement of patient procedures.
- Distribution
- Domestic distribution nationwide. Foreign distribution to Australia Canada China Hong Kong Italy Malaysia Netherlands New Zealand Singapore Thailand
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0617-2024
- 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 H
Ongoing Class II Medical devices
- Recall started
- 10 April 2023
- Reason
- In the remote occurrence in which the electrical contactor component present in the drying chambers of the Reliance Vision Multi-Chamber Washer/Disinfector malfunctions, the heating elements in the drying chamber could overheat, eventually resulting in smoke and/or fire.
- Distribution
- Worldwide Distribution: US (Nationwide) and OUS (Foreign) to countries of: China, Lithuania, Saudi Arabia, Korea, Republic of, Canada, Taiwan, United Kingdom, Spain, Australia, New Zealand, Spain, Brazil, Bahrain, Switzerland, Great Britain, South Africa, Hong Kong, Qatar.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1595-2023
- Reliance Vision Multi-Chamber Washer/Disinfector, Reference Number FH83062
Ongoing Class II Medical devices
- Recall started
- 17 March 2023
- Reason
- Light handle covers may separate from the light handle (detach and fall off) during use, this could result in a procedure delay and/or impact the sterile field which could result in an injury to the patient
- Distribution
- Worldwide - US Nationwide distribution including Puerto Rico and the countries of Canada, Australia.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1475-2023, Z-1476-2023
- 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 su
- 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 maintai
Ongoing Class II Medical devices
- Recall started
- 12 December 2022
- Reason
- Biological indicator (BI) used to promote growth of the G. stearothermophilus and B. atrophaeus spores was inconsistent in promoting growth throughout lot , some BIs within the lot performed as intended while others did not. When used to monitor steam and ethylene oxide sterilization cycles, the potential hazard is that the BI will show no growth indicating that the cycle was effective, even if it may not have been.
- Distribution
- Nationwide Foreign: AE AT CA CO ES FI GU IN IT JP MX SG TH TW ZA
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0781-2023, Z-0779-2023, Z-0780-2023, Z-0778-2023
- 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
- 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
- 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
- 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
Terminated Class II Medical devices
- Recall started
- 17 October 2022
- Terminated
- 28 May 2024
- Reason
- Two electronic diode components (D1 & D4) placed in the reverse orientation on the controller printed circuit board assembly may result in premature wear of the power regulator, leading to the regulators failure which could cause a full power loss. If the regulator failure were to occur during a patient procedure, a procedural delay may result
- Distribution
- US Nationwide distribution in the states of Arizona, Illinois, Tennessee, Virginia.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0241-2023
- 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): G
Terminated Class II Medical devices
- Recall started
- 2 September 2022
- Terminated
- 2 January 2025
- Reason
- The scalpel holder may separate from the handle for certain lots. If the tip falls off during use, it could fall into the patient's mouth which may result in a cut to the patient's mouth and also presents a choking hazard.
- Distribution
- Distribution to US states of IL, MA, NC, SC, and TN, Canada, China, Japan, Malaysia, Turkey, Great Britain, and India.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0079-2023
- Hu-Friedy K360 Scalpel Handle, 360 Degree Scalpel Handle, REF K360
Terminated Class II Medical devices
- Recall started
- 22 April 2022
- Terminated
- 4 November 2024
- Reason
- The firm identified that when the electrical contactor component in the drying chamber of the Washer/Disinfector malfunctions, the heating elements in the drying chamber could overheat, eventually resulting in smoke and/or fire.
- Distribution
- Worldwide distribution - US Nationwide.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1256-2022
- Reliance Synergy Washer/Disinfector
Terminated Class II Medical devices
- Recall started
- 22 March 2022
- Terminated
- 29 January 2024
- Reason
- Product not approved for release for US distribution
- Distribution
- Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1118-2022, Z-1119-2022
- 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
- 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
Terminated Class II Medical devices
- Recall started
- 21 January 2021
- Terminated
- 10 November 2021
- Reason
- On January 7, 2021, STERIS identified that the glued bond between the beam and the leg spar assembly may begin to separate over time. This could result in unexpected movement of the affected leg spar if the separation occurred during a patient procedure.
- Distribution
- Domestic: AL, AK, AR, AZ, CA, CO, CT, DC, FL, GA, ID, IL IN, IW, KS, KY, LA, ME, MD, MI, MN, MO, NE, NV, NJ, NY, NC, ND, OH, OK, OR, PA, PR, SC, TX, UT, VT, VA, WA, WV, WI. Foreign: Canada, South Korea, Panama, Qatar, Thailand.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1149-2021
- OT1000 Series Orthopedic Surgical Tables
Terminated Class II Medical devices
- Recall started
- 11 December 2020
- Terminated
- 21 June 2022
- Reason
- The electrical contactor component present in the drying chamber of the Reliance Vision Single-Chamber Washer/Disinfector may malfunction, potentially leading to the heating elements in the drying chamber to overheat, eventually resulting in smoke and/or fire.
- Distribution
- Worldwide distribution - US Nationwide distribution and the countries of Australia, Belgium, Brazil, Bulgaria, Canada, Chile, China, Ecuador, France, Germany, Hong Kong, Ireland, Israel, Italy, Japan, Korea, Republic of Malaysia, Mexico, New Zealand, Panama, Portugal, Russian Federation, Saudi A
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0876-2021
- 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 plast
Terminated Class II Medical devices
- Recall started
- 2 December 2020
- Terminated
- 21 June 2022
- Reason
- Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following steam processing causing cosmetic defects on the exterior of the pouch and in some instances, transference of the ink onto the device(s) contained within the pouch
- Distribution
- Nationwide Foreign:
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0792-2021, Z-0789-2021, Z-0794-2021, Z-0793-2021, Z-0791-2021, Z-0788-2021, Z-0796-2021, Z-0795-2021, Z-0797-2021, Z-0799-2021, Z-0798-2021, Z-0790-2021 and 2 more
- Vis-U-All High Temp 7.5"x13.5" Heat Seal Pouch 200 pouches per box; 5 boxes per case Model Number: 883713
- Vis-U-All High Temperature Tubing 9"x100'. One roll per box; 10 boxes per case 6 rolls/cs Model Number: 881091
- Vis-U-All High Temp 13"x18" Self Seal Pouch 100 pouches per box; 4 boxes per case Model Number: 884118
- Vis-U-All High Temp 3.5"x9" Self Seal Pouch 200 pouches per box; 4 boxes per case Model Number: 884039
- Vis-U-All High Temp 6"x10" Heat Seal Pouch 200 pouches per box; 5 boxes per case Model Number: 883610
- Vis-U-All High Temperature Tubing 6"x100'. One roll per box; 10 boxes per case 10 rolls/cs Model Number: 881061
- Vis-U-All High Temp 5.5"x10" Self Seal Pouch 200 pouches per box; 4 boxes per case Model Number: 884510
- Vis-U-All High Temp 4"x11" Self Seal Pouch 200 pouches per box; 4 boxes per case Model Number: 884411
- and 6 more product lines
Terminated Class II Medical devices
- Recall started
- 19 November 2020
- Terminated
- 25 October 2023
- Reason
- STERIS has identified that certain lots of diluted 4-Zyme may contain bacteria, specifically Pseudomonas fluorescens. The presence of this bacteria can cause the color of the detergent to darken over time. There is an improbable risk to users of the product from exposure to this bacteria, and no risk to patients.
- Distribution
- Worldwide distribution - US Nationwide distribution including in the states of CA, DE, CO, VA, FL, WA, TX, OH, PA, MA, IA, CT and the countries of United Kingdom, Saudi Arabia, Portugal, Denmark, Ireland, United Arab Emirates, South Korea, Australia, Greece, Ashmore & Cartier Islands, Belgium, Cana
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0830-2021
- 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 reprocessin
Terminated Class III Medical devices
- Recall started
- 7 October 2020
- Terminated
- 14 July 2021
- Reason
- Potential for cleaning solution intrusion into endoscope
- Distribution
- Nationwide Foreign: Canada, Italy, Kuwait, United Kingdom, United Arab Emirates
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0458-2021
- Olympus Leak Test Adapter used with Acu-sInQ Complete Endoscope Cleaning Aid Systems-intended to assist manual flexible endoscope cleaning Part number: 0600818OKN
Terminated Class II Medical devices
- Recall started
- 26 June 2020
- Terminated
- 22 December 2020
- Reason
- A recent FDA inspection at the firm identified that the foil test performed during installation of the device does not have clear acceptance criteria.
- Distribution
- Worldwide distribution - US Nationwide distribution and the countries of Canada, Mexico, and United Arab Emirates.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2700-2020
- InnoWave Sonic Irrigator, There are currently six models (PCF, Pro, Ultra, Ultra+, Unity, and ECO) - Product Usage: STERIS InnoWave Sonic Irrigators are intended to thoroughly clean (remove tissue, blood, and other conta
Terminated Class II Medical devices
- Recall started
- 22 October 2019
- Terminated
- 9 June 2020
- Reason
- The locking pin of the front wheel asse mbly of the Evolution Transfer Carriages may not remain full y engaged with the transfer carriage and result in the transfer carriage and loading car unexpectedly falling forward
- Distribution
- Nationwide Foreign: Canada, Peru, Mexico, Brazil, Saudi Arabia, Columbia
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0586-2020
- Evolution Loading Car and Transfer Carriage- Accessory to the Sterilizer, Steam
Terminated Class II Medical devices
- Recall started
- 22 October 2019
- Terminated
- 6 May 2020
- Reason
- Potential for the incorrect pressure safety valve being included in the Preventive Maintenance (PM) kit for the 3000 Small Sterilizers.
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of AL AR AZ CA CO DE FL GA HI IA ID IL IN KS LA MD ME MI MN MO MS MT NC NE NH NJ NM NV NY OH OK OR PA RI SC SD TN TX UT VA WA WI WV, and country of Canada.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0604-2020
- Eagle 3000 Sterilizer, small steam sterilizer. Product Usage: The Eagle 3000 Small Sterilizer is designed for sterilization of certain materials used in healthcare facilities, and are available in two configurations: G
Terminated Class II Medical devices
- Recall started
- 26 December 2018
- Terminated
- 16 June 2020
- Reason
- The ATLAS loading car may not remain fully engaged with the latch on the transfer carriage when the loading car is empty, potentially resulting in the loading car unexpectedly sliding forward or falling to one side.
- Distribution
- Nationwide domestic distribution. Foreign distribution to Canada, Costa Rica, Indonesia, South Korea, and Taiwan.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0824-2019
Terminated Class II Medical devices
- Recall started
- 20 December 2018
- Terminated
- 22 July 2019
- Reason
- The software in the systems may not process the cycle originally intended. This could result in damage to the various medical devices and instruments processed in the washer/disinfector or potential for inadequate cleaning or disinfection.
- Distribution
- The products were distributed to the following US states: AL, AR, CA, CO, FL, GA, IL, LA, MA, MD, ME, MI, NC, NJ, NM, NY, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV. The products were distributed to the following foreign countries: Bahrain, Brazil, Canada, China, Saudi Arabia, South Korea,
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0996-2019, Z-0995-2019
- AMSCO 5000 Series Washer/Disinfector Model # 5052
- AMSCO 3000 Series Washer/Disinfector Model # 3052
Terminated Class II Medical devices
- Recall started
- 26 July 2018
- Terminated
- 30 March 2020
- Reason
- There is the potential for a scenario where a punctured cup of sterilant expires while the system is powered down, upon power-up the unit will not detect the expired cup of sterilant; allowing for subsequent cycles to be run.
- Distribution
- Worldwide Distribution: US(nationwide) and to countries of: Albania, Algeria, Australia, Austria, Bahrain, Bangladesh, Belgium, Belarus, Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Curacao, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Germany,
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2959-2018
- AMSCO V-PRO 1, V-PRO 1 Plus, and V-PRO maX Low Temperature Sterilization Systems The V-PRO 1, V-PRO 1 Plus, and V-PRO maX Low Temperature Sterilization Systems, using VAPROX HC Sterilant, are intended for use in the
Terminated Class II Medical devices
- Recall started
- 23 May 2018
- Terminated
- 5 November 2019
- Reason
- The firm has become aware that the Reliance 1227 Cart and Utensil Washer/Disinfector s Chemical Low Level alarm, intended to prevent the user from initiating a cycle when a low chemical level situation occurs, does not operate as intended. Currently, if a low chemical level situation occurs, the alarm will only be generated at the unit s next power-up or when accessing service mode. The failure of the Reliance 1227 to identify that the chemicals used for cleaning are low or empty could result in bedpans and urinals, basins, case carts, beds, theater shoes and other miscellaneous reusable patient care items not being properly cleaned before disinfection or reuse.
- Distribution
- Worldwide Distribution - US Nationwide in the states of AL, AK, CA, CO, CN, DE, FL, GA, IL, IA, KS, KY, LA, MA, MI, NJ, NY, ND, OH, OK, OR, PA, RI, SC, TN, TX, VT, VA, WI, and WV. Foreign distribution to Canada.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2392-2018
- Reliance 1227 Cart and Utensil Washer/Disinfector, FW03101, FW03102, FW03S003 Product Usage: The Reliance 1227 Cart and Utensil Washer/Disinfector is intended for use in the cleaning and low-level disinfection of bed
Terminated Class II Medical devices
- Recall started
- 28 September 2017
- Terminated
- 12 September 2018
- Reason
- Correction to update sterilizer software to prohibit the use of expired sterilant prior to the start of a sterilization cycle.
- Distribution
- Distributed in 44 states: AL, AK, AZ, AR, CA, CO, DE, FL, GA, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, WY; Puerto Rico, and the following countries: Algeria, Australia, Azerbaijan, Bahrain, Brazil, Brunei
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0772-2018
- V-PRO 60 Low Temperature Sterilization System (UDI: 00724995152000)
Terminated Class II Medical devices
- Recall started
- 15 June 2017
- Terminated
- 17 July 2018
- Reason
- On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate following steam processing causing cosmetic defects on the exterior of the pouch and in some instances, transference of the ink onto the device(s) contained within the pouch.
- Distribution
- US Nationwide Distribution
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0749-2018, Z-0750-2018, Z-0754-2018, Z-0751-2018, Z-0743-2018, Z-0759-2018, Z-0770-2018, Z-0761-2018, Z-0767-2018, Z-0766-2018, Z-0763-2018, Z-0755-2018 and 17 more
- Vis-U-All High Temp 4"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 medica
- Vis-U-All High Temp 10"x15" Heat 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 medi
- 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 med
- Vis-U-All High Temp 16"x16" Heat 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 medi
- Vis-U-All High Temp 7.5"x13" 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 med
- Vis-U-All High Temp 8"x10" 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 medic
- Vis-U-All High Temp 7.5"x13" 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 med
- Vis-U-All High Temp 3.5"x9" 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 medi
- and 21 more product lines
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.