Disinfector, Medical Devices

Reports per year

Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.

Recent recalls

• 2025-12-11Open, ClassifiedProcess control

  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 hard-surfaced rigid surgical instruments (such as forceps and clamps), utensils (such as bedpans, urinals, trays, bowl, basin and kidney dishes), rubber and plastic goods, theatre shoes and other similar and related articles found in healthcare facilities.

  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).

• 2025-12-11Open, ClassifiedProcess control

  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 simple hard-surfaced rigid surgical instruments (such as forceps and clamps), utensils (such as bedpans, urinals, trays, bowl, basin and kidney dishes), rubber and plastic goods, theatre shoes and other similar and related articles found in healthcare facilities.

  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).

• 2025-10-01Open, ClassifiedUnder Investigation by firm

  Getinge 88-Series Washer- Disinfector. Model Number: 88-5.

  Potential for device to overheat during operation if the circulation pressure calibration was not performed or had been performed incorrectly, and the low-pressure alarm is not triggered.

• 2025-05-05Open, ClassifiedUnder Investigation by firm

  Washer Disinfector Aquadis 56; Model Number: 56A

  The frequency inverter is not programmed by supplier according to specification which causes the circulation pump to start earlier than expected, resulting in additional wear and tear, earlier than expected, on the axial seal in the pump housing.

• 2025-05-05Open, ClassifiedUnder Investigation by firm

  Washer Disinfector Aquadis 56; Model Number: 56M

  The frequency inverter is not programmed by supplier according to specification which causes the circulation pump to start earlier than expected, resulting in additional wear and tear, earlier than expected, on the axial seal in the pump housing.

• 2023-05-17Open, ClassifiedNonconforming Material/Component

  Reliance Vision Multi-Chamber Washer/Disinfector, Reference Number FH83062

  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.

• 2020-02-18TerminatedDevice Design

  Getinge 88-Series-washer disinfectors intended for cleaning, disinfection and drying Model Number: 88-5 Part Number: 88-103; 88-203

  Potential 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 infection from contaminated water

• 2017-06-02TerminatedDevice Design

  The Olympic Pasteurmatic 3000 and Olympic Pasteurmatic 3500 are intended for cleaning and high-level disinfection of respiratory therapy and anesthesia equipment by killing vegetative bacteria and viruses, in a hot water bath at ~160 - ~170 F for 30 minutes. Catalog Number/Description: 007168 PM3500 ASSY (15KW 208/120V) 007169 PM3000 ASSY (9KW 208/120V) 007169R PM3 (9KW 208/120) REFURB 007170 PM3 ASSY (8.3KW 200V DELTA) 007171 PM3 ASSY (9KW 220V SING PH) 52640 PASTEURMATIC 3000 W/O BASKETS 52640R PM 3000 w/o Baskets Refurb 52640-200 PM 3000 W/O BASKETS 200V 52640-220 PM 3000 W/O BASKETS 220V 52641 PASTEURMATIC 3000 W/BASKET S 52641R PM 3000 w/ Baskets Refurb 52641-200 PM 3000 W BASKETS 200V 52641-220 PM 3000 W/ BASKETS 220V 52650 PASTEURMATIC 3500 W/O BASKET 52651 PASTEURMATIC 3500 W/BASKETS S

  Olympic Pasteurmatic 3000/3500 Systems are recalled because they do not fully meet todays regulatory requirements. Given the age of the products design, component and technology obsolescence, and the time involved in fully complying with the latest design and development standards, the firm decided to recall of the Olympic Pasteurmatic 3000/3500 System devices by means of disabling the devices.

• 2015-08-25TerminatedSoftware Manufacturing/Software Deployment

  Getinge 86 Series Washer/Disinfector with G1 control system software, Model 8666 and Model 8668. For use in healthcare facilities and laboratories where reusable items such as instruments, utensils, anesthesia sets, and glassware are handled for decontamination purposes.

  Getinge Disinfection AB has initiated a Field Correction due to the potential for unauthenticated remote access to the product over the network.

• 2014-12-23TerminatedDevice Design

  GETINGE 46-SERIES Medical Washer-Disinfector, Models 46-4 and 46-5, with PACS 300/350 Control Series with dryer --- Class II, exempt from 510(k) requirements. For use in healthcare facilities and laboratories where reusable items such as instruments, utensils, anesthesia sets, and glassware are handled for decontamination purposes.

  Getinge Disinfection AB received complaints regarding sediment residuals in the manifold of the washer and disinfector of Getinge 46-Series (CM302) with PACS 300/350 control. After performing detailed root cause analysis, the firm has identified the problem as insufficient water flow throughout the manifold due to formation of air pockets where sedimentation may occur.