By device type

Disinfector, Medical Devices: device recalls

FDA device recalls whose record carries FDA's device name “Disinfector, Medical Devices”: 31 records; the 24 recalls led by one, newest first. The name is FDA's classification, as written in the record.

Recent recalls

1 of 24

Dec. 17, 2025Class IIFDA · Medical device

AMSCO 7052HP Washer/Disinfector Model/Catalog Number: 7052HP Product… and 1 more product

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).

Filed by: Steris Corporation · Also listed under Steris

More recalls

23 in all years

Oct. 8, 2025Getinge 88-Series Washer- Disinfector…Class IIPotential for device to overheat during operation if the circulation pressure calibration was not performed or had been performed incorrectly, and… Recall began Aug. 29, 2025
May 14, 2025Washer Disinfector Aquadis 56… and 1 more productClass IIThe frequency inverter is not programmed by supplier according to specification which causes the circulation pump to start earlier than expected… Recall began April 2, 2025
May 24, 2023Reliance Vision Multi-Chamber Washer/Disinfector…Class IIIn the remote occurrence in which the electrical contactor component present in the drying chambers of the Reliance Vision Multi-Chamber… Recall began April 10, 2023
June 15, 2022Reliance Synergy Washer/DisinfectorClass IIThe firm identified that when the electrical contactor component in the drying chamber of the Washer/Disinfector malfunctions, the heating elements… Recall began April 22, 2022
June 15, 2022Getinge CM320-2 CHAMBER WU Series Washer Disinfector- For Use as a… and 1 more productClass IIVerification of installation not documented or may be incomplete, could result in harm to the user such as skin burns, smoke inhalation, electric… Recall began April 13, 2022
May 25, 2022Getinge 9100-Series Washer Disinfector models: 9120E…Class IIInadequate documentation verifying whether device installation has been executed in accordance with the manufacturer's requirements. This can lead to… Recall began April 1, 2022
Feb. 24, 2021Getinge CM320 Series Washer Disinfector…Class IIThe potential that the plastic inlet hose connections may deform or break as a result of material fatigue and/or over tightening of the clamps. A… Recall began Dec. 21, 2020
Jan. 27, 2021Reliance Vision Single-Chamber Washer/Disinfector…Class IIThe electrical contactor component present in the drying chamber of the Reliance Vision Single-Chamber Washer/Disinfector may malfunction… Recall began Dec. 11, 2020
March 18, 2020Getinge 88-Series-washer disinfectors intended for cleaning…Class IIPotential leakage that may occur due to ruptured spot welds in the chamber, could generate a situation for the user such as risk for slipping or… Recall began Feb. 10, 2020
March 4, 2020Getinge 46-Series Washer Disinfector Model # 46-4… and 1 more productClass IIIDue to a missing water intake for Deionized water on the Getinge 46-Series Washer Disinfector. There were no valve, hose, or clamps for this option… Recall began Jan. 16, 2020
Advertisement
June 19, 2019Getinge 86-Series-Medical Washer-Disinfector Part Number: S-86662003… and 1 more productClass IIPossibility that inlet pump hose of the Washer Disinfector Getinge 86-Series (S-8666, S-8668) might collapse during use result in low water pressure… Recall began May 20, 2019
March 20, 2019AMSCO 3000 Series Washer/Disinfector Model # 3052 and 1 more productClass IIThe software in the systems may not process the cycle originally intended. This could result in damage to the various medical devices and instruments… Recall began Dec. 20, 2018
July 18, 2018Reliance 1227 Cart and Utensil Washer/Disinfector…Class IIThe firm has become aware that the Reliance 1227 Cart and Utensil Washer/Disinfector s Chemical Low Level alarm, intended to prevent the user from… Recall began May 23, 2018
April 25, 2018Getinge AGS… and 1 more productClass IIThere is potential for a cart with disinfected goods to unload without the trolley being docked. Disinfected goods could end up falling to the floor… Recall began March 2, 2018
July 19, 2017The Olympic Pasteurmatic 3000 and Olympic Pasteurmatic 3500 are intended for cleaning and high-level…Class IIOlympic Pasteurmatic 3000/3500 Systems are recalled because they do not fully meet todays regulatory requirements. Given the age of the products… Recall began May 22, 2017
Aug. 26, 2015Getinge 86 Series Washer/Disinfector with G1 control system software…Class IIIGetinge Disinfection AB has initiated a Field Correction due to the potential for unauthenticated remote access to the product over the network. Recall began June 26, 2015
Dec. 31, 2014GETINGE 46-SERIES Medical Washer-Disinfector…Class IIGetinge Disinfection AB received complaints regarding sediment residuals in the manifold of the washer and disinfector of Getinge 46-Series (CM302)… Recall began Nov. 26, 2014
July 16, 2014Reliance 1227 Cart and Utensil Washer/Disinfector Product Usage: Usage: The Reliance 1227 Cart and Utensil…Class IIISTERIS has identified that deformation of the washer’s door handle pin may occur when the door handle is rotated with sufficient force. Should…
Oct. 23, 2013Getinge 46-Series Medical Washer-Disinfectors…Class IIGetinge Disinfection AB initiated a voluntary field safety correction for the Getinge 46-Series electrically-heated Washer Disinfectors due to… Recall began July 30, 2013
Aug. 8, 2012The Reliance 130 and 130L Cart Washer/Disinfector is a high capacity mechanical washer intended for use in…Class IITo ensure that users are properly operating the Reliance 130 and 130L Cart Washers, a door close confirmation button and door open delay will be…
Aug. 1, 2012Getinge brand --- large capacity…Class IIGetinge Disinfection AB is voluntarily correcting Washer Disinfectors, Getinge Electrically Heated 9100-Series manufactured between 2009-05-04… Recall began May 25, 2012
Sept. 1, 2011Reliance Vision Single Chamber Washer/Disinfector…STERIS learned that Vision SC Washer users were experiencing nuisance alarms and/or aborted cycles that are adversely affecting the reliability and… Recall began May 9, 2011
June 5, 2003Model 8666 Washer/Disinfector with holding tank heater option…Hot water may splash from the washer chamber creating a burn hazard. Recall began March 25, 2003

Reports to FDA about this kind of device

From Nov. 13, 2021 to Nov. 4, 2026, FDA's adverse event database (MAUDE) received 405 reports for Disinfector, Medical Devices (FDA product code MEC): 39 an injury; 365 a malfunction.

Problems named most in the reports:

Leak/Splash 47Detachment of Device or Device Component 43Use of Device Problem 42Device Fell 31Insufficient Device Problem Information 29Smoking 26

Reports come from manufacturers, hospitals, doctors and patients. FDA does not confirm that a device caused an event, a malfunction report may involve no harm, and a count follows how many devices are in use. Counts as returned by openFDA's device adverse event service; in FDA's words, do not rely on openFDA to make decisions regarding medical care. Talk to your doctor about a device you use.

Report a mistake on this page