Disinfector, Medical Devices
FDA product code MEC · Class II (moderate risk) · 21 CFR 880.6992 · General Hospital
2510(k) clearances
0PMA approvals
30recalls
Manufacturers
510(k) clearances
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0910-2026 Class II | AMSCO 7053HP Washer/Disinfector Model/Catalog Number: 7053HP Product Description: The…Wire connected to the electrical box may shift out of its intended position, which may result in electrical… | Steris Corporation | 11/19/2025Open, Classified |
| Z-0909-2026 Class II | AMSCO 7052HP Washer/Disinfector Model/Catalog Number: 7052HP Product Description: The…Wire connected to the electrical box may shift out of its intended position, which may result in electrical… | Steris Corporation | 11/19/2025Open, Classified |
| Z-0016-2026 Class II | Getinge 88-Series Washer- Disinfector. Model Number: 88-5.Potential for device to overheat during operation if the circulation pressure calibration was not performed… | Getinge Disinfection Ab | 08/29/2025Open, Classified |
| Z-1721-2025 Class II | Washer Disinfector Aquadis 56; Model Number: 56MThe frequency inverter is not programmed by supplier according to specification which causes the circulation… | Getinge Disinfection Ab | 04/02/2025Open, Classified |
| Z-1720-2025 Class II | Washer Disinfector Aquadis 56; Model Number: 56AThe frequency inverter is not programmed by supplier according to specification which causes the circulation… | Getinge Disinfection Ab | 04/02/2025Open, Classified |
| Z-1595-2023 Class II | Reliance Vision Multi-Chamber Washer/Disinfector, Reference Number FH83062In the remote occurrence in which the electrical contactor component present in the drying chambers of the… | Steris Corporation | 04/10/2023Open, Classified |
| Z-1256-2022 Class II | Reliance Synergy Washer/DisinfectorThe firm identified that when the electrical contactor component in the drying chamber of the… | Steris Corporation | 04/22/2022Terminated |
| Z-1249-2022 Class II | Getinge CM320 WUWD Series Washer Disinfector-For use as a multi-chamber…Verification of installation not documented or may be incomplete, could result in harm to the user such as… | Getinge Usa Sales Inc | 04/13/2022Open, Classified |
| Z-1248-2022 Class II | Getinge CM320-2 CHAMBER WU Series Washer Disinfector- For Use as a multi-chamber…Verification of installation not documented or may be incomplete, could result in harm to the user such as… | Getinge Usa Sales Inc | 04/13/2022Open, Classified |
| Z-1078-2022 Class II | Getinge 9100-Series Washer Disinfector models: 9120E, 9125E, 9127E, 9128E, 9122EW, 9128EW.Inadequate documentation verifying whether device installation has been executed in accordance with the… | Getinge Usa Sales Inc | 04/01/2022Open, Classified |
| Z-1124-2021 Class II | Getinge CM320 Series Washer Disinfector - Product Usage: A multi chamber washer…The potential that the plastic inlet hose connections may deform or break as a result of material fatigue… | Getinge Group Logistics America, LLC | 12/21/2020Terminated |
| Z-0876-2021 Class II | Reliance Vision Single-Chamber Washer/Disinfector - Product Usage: intended for use in…The electrical contactor component present in the drying chamber of the Reliance Vision Single-Chamber… | Steris Corporation | 12/11/2020Terminated |
| Z-1475-2020 Class II | Getinge 88-Series-washer disinfectors intended for cleaning, disinfection and drying…Potential leakage that may occur due to ruptured spot welds in the chamber, could generate a situation for… | Maquet Cardiovascular Us Sales, Llc | 02/10/2020Terminated |
| Z-1391-2020 Class III | Getinge 46-Series Washer Disinfector Model # 46-4, Part Number:46-4-503 Product Usage:…Due to a missing water intake for Deionized water on the Getinge 46-Series Washer Disinfector. There were no… | Maquet Cardiovascular Us Sales, Llc | 01/16/2020Terminated |
| Z-1390-2020 Class III | Getinge 46-Series Washer Disinfector Model # 46-4, Part Number:46-4-502 Product Usage:…Due to a missing water intake for Deionized water on the Getinge 46-Series Washer Disinfector. There were no… | Maquet Cardiovascular Us Sales, Llc | 01/16/2020Terminated |
| Z-1778-2019 Class II | Getinge 86-Series-Medical Washer-Disinfector Part Number: S-86682003 Product Usage: The…Possibility that inlet pump hose of the Washer Disinfector Getinge 86-Series (S-8666, S-8668) might collapse… | Maquet Cardiovascular Us Sales, Llc | 05/20/2019Terminated |
| Z-1777-2019 Class II | Getinge 86-Series-Medical Washer-Disinfector Part Number: S-86662003 Product Usage:…Possibility that inlet pump hose of the Washer Disinfector Getinge 86-Series (S-8666, S-8668) might collapse… | Maquet Cardiovascular Us Sales, Llc | 05/20/2019Terminated |
| Z-0996-2019 Class II | AMSCO 5000 Series Washer/Disinfector Model # 5052The software in the systems may not process the cycle originally intended. This could result in damage to… | Steris Corporation | 12/20/2018Terminated |
| Z-0995-2019 Class II | AMSCO 3000 Series Washer/Disinfector Model # 3052The software in the systems may not process the cycle originally intended. This could result in damage to… | Steris Corporation | 12/20/2018Terminated |
| Z-2392-2018 Class II | Reliance 1227 Cart and Utensil Washer/Disinfector, FW03101, FW03102, FW03S003 Product…The firm has become aware that the Reliance 1227 Cart and Utensil Washer/Disinfector s Chemical Low Level… | Steris Corporation | 05/23/2018Terminated |
| Z-1380-2018 Class II | Getinge AGS, FSLC, FSUC, RC accessory to Washer- Disinfector 88 Series UDI Info:…There is potential for a cart with disinfected goods to unload without the trolley being docked. Disinfected… | Getinge Disinfection Ab | 03/02/2018Terminated |
| Z-1379-2018 Class II | Getinge AGS, FSLC, FSUC, RC accessory to Washer- Disinfector 86 Series UDI Info: 86…There is potential for a cart with disinfected goods to unload without the trolley being docked. Disinfected… | Getinge Disinfection Ab | 03/02/2018Terminated |
| Z-2701-2017 Class II | The Olympic Pasteurmatic 3000 and Olympic Pasteurmatic 3500 are intended for cleaning…Olympic Pasteurmatic 3000/3500 Systems are recalled because they do not fully meet todays regulatory… | Natus Medical Incorporated | 05/22/2017Terminated |
| Z-2419-2015 Class III | Getinge 86 Series Washer/Disinfector with G1 control system software, Model 8666 and…Getinge Disinfection AB has initiated a Field Correction due to the potential for unauthenticated remote… | Getinge Disinfection Ab | 06/26/2015Terminated |
| Z-0852-2015 Class II | GETINGE 46-SERIES Medical Washer-Disinfector, Models 46-4 and 46-5, with PACS 300/350…Getinge Disinfection AB received complaints regarding sediment residuals in the manifold of the washer and… | Getinge Disinfection Ab | 11/26/2014Terminated |
| Z-2036-2014 Class III | Reliance 1227 Cart and Utensil Washer/Disinfector Product Usage: Usage: The Reliance…STERIS has identified that deformation of the washers door handle pin may occur when the door handle is… | Steris Corporation | 06/30/2014Terminated |
| Z-0018-2014 Class II | Getinge 46-Series Medical Washer-Disinfectors, Listing # E208196 Product Usage: The…Getinge Disinfection AB initiated a voluntary field safety correction for the Getinge 46-Series… | Getinge Disinfection | 07/30/2013Terminated |
| Z-2122-2012 Class II | The Reliance 130 and 130L Cart Washer/Disinfector is a high capacity mechanical washer…To ensure that users are properly operating the Reliance 130 and 130L Cart Washers, a door close… | Steris Corporation | 07/14/2012Terminated |
| Z-2079-2012 Class II | Getinge brand --- large capacity, floor loading jet spray, washers for mechanical…Getinge Disinfection AB is voluntarily correcting Washer Disinfectors, Getinge Electrically Heated… | Getinge USA Inc | 05/25/2012Terminated |
| Z-3118-2011 | Reliance Vision Single Chamber Washer/Disinfector, Model # 1802983, The Vision Single…STERIS learned that Vision SC Washer users were experiencing nuisance alarms and/or aborted cycles that are… | Steris Corporation | 05/09/2011Terminated |