Getinge Aquadis 56 56MRecalls & reported problems
Getinge Disinfection AB · Washer disinfector · Class 2
All models of Getinge Aquadis 56 (2)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 11
- Deaths reported
- 0
- Injuries reported
- 10
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 07340153710351), received between Jul 26, 2024 and Apr 8, 2026 — classified as 10 injuries, 1 malfunction.
The most frequently reported specific device problem is “Device Emits Odor” (10 reports).
1 FDA recall record name this device's identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Recalls naming this device
- Apr 2, 2025Open, Classified
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.
Z-1721-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported problems
Device problems
- Device Emits Odor10
- Device Damaged Prior to Receipt by User1
- Tear, Rip or Hole in Device Packaging1
Patient problems
- Cough10
- Eye Pain10
- Sore Throat10
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.
InjuryApr 8, 2026Device Emits Odor
GETINGE HAS BEEN AWARE ABOUT A CHEMICAL ODOR FROM WASHER DISINFECTOR AQUADIS 56-SERIES, MODEL NAME 56M. THE ODOR LED TO HEALTH SYMPTOMS REPORTED BY STAFF INCLUDING COUGHING, SORE THROAT, AND BREATHING ISSUES. SEVERAL INDIVIDUALS REQUIRED MEDICAL TESTING AND TREATMENT. IN RESPONSE, THE UNIT WAS TAKEN OUT OF SERVICE.
Patient problems: Cough; Eye Pain; Sore Throat
MAUDE report 24819633 ↗InjuryApr 8, 2026Device Emits Odor
GETINGE HAS BEEN AWARE ABOUT A CHEMICAL ODOR FROM WASHER DISINFECTOR AQUADIS 56-SERIES, MODEL NAME 56M. THE ODOR LED TO HEALTH SYMPTOMS REPORTED BY STAFF INCLUDING COUGHING, SORE THROAT, AND BREATHING ISSUES. SEVERAL INDIVIDUALS REQUIRED MEDICAL TESTING AND TREATMENT. IN RESPONSE, THE UNIT WAS TAKEN OUT OF SERVICE.
Patient problems: Cough; Eye Pain; Sore Throat
MAUDE report 24819367 ↗InjuryApr 8, 2026Device Emits Odor
GETINGE HAS BEEN AWARE ABOUT A CHEMICAL ODOR FROM WASHER DISINFECTOR AQUADIS 56-SERIES, MODEL NAME 56M. THE ODOR LED TO HEALTH SYMPTOMS REPORTED BY STAFF INCLUDING COUGHING, SORE THROAT, AND BREATHING ISSUES. SEVERAL INDIVIDUALS REQUIRED MEDICAL TESTING AND TREATMENT. IN RESPONSE, THE UNIT WAS TAKEN OUT OF SERVICE.
Patient problems: Cough; Eye Pain; Sore Throat
MAUDE report 24817474 ↗InjuryApr 8, 2026Device Emits Odor
GETINGE HAS BEEN AWARE ABOUT A CHEMICAL ODOR FROM WASHER DISINFECTOR AQUADIS 56-SERIES, MODEL NAME 56M. THE ODOR LED TO HEALTH SYMPTOMS REPORTED BY STAFF INCLUDING COUGHING, SORE THROAT, AND BREATHING ISSUES. SEVERAL INDIVIDUALS REQUIRED MEDICAL TESTING AND TREATMENT. IN RESPONSE, THE UNIT WAS TAKEN OUT OF SERVICE.
Patient problems: Cough; Eye Pain; Sore Throat
MAUDE report 24817120 ↗InjuryApr 3, 2026Device Emits Odor
GETINGE HAS BEEN AWARE ABOUT A CHEMICAL ODOR FROM WASHER DISINFECTOR AQUADIS 56-SERIES, MODEL NAME 56M. THE ODOR LED TO HEALTH SYMPTOMS REPORTED BY STAFF INCLUDING COUGHING, SORE THROAT, AND BREATHING ISSUES. SEVERAL INDIVIDUALS REQUIRED MEDICAL TESTING AND TREATMENT. IN RESPONSE, THE UNIT WAS TAKEN OUT OF SERVICE.
Patient problems: Cough; Eye Pain; Sore Throat
MAUDE report 24781211 ↗InjuryApr 3, 2026Device Emits Odor
GETINGE HAS BEEN AWARE ABOUT A CHEMICAL ODOR FROM WASHER DISINFECTOR AQUADIS 56-SERIES, MODEL NAME 56M. THE ODOR LED TO HEALTH SYMPTOMS REPORTED BY STAFF INCLUDING COUGHING, SORE THROAT, AND BREATHING ISSUES. SEVERAL INDIVIDUALS REQUIRED MEDICAL TESTING AND TREATMENT. IN RESPONSE, THE UNIT WAS TAKEN OUT OF SERVICE.
Patient problems: Cough; Eye Pain; Sore Throat
MAUDE report 24774175 ↗InjuryApr 3, 2026Device Emits Odor
GETINGE HAS BEEN AWARE ABOUT A CHEMICAL ODOR FROM WASHER DISINFECTOR AQUADIS 56-SERIES, MODEL NAME 56M. THE ODOR LED TO HEALTH SYMPTOMS REPORTED BY STAFF INCLUDING COUGHING, SORE THROAT, AND BREATHING ISSUES. SEVERAL INDIVIDUALS REQUIRED MEDICAL TESTING AND TREATMENT. IN RESPONSE, THE UNIT WAS TAKEN OUT OF SERVICE.
Patient problems: Cough; Eye Pain; Sore Throat
MAUDE report 24774152 ↗InjuryApr 3, 2026Device Emits Odor
GETINGE HAS BEEN AWARE ABOUT A CHEMICAL ODOR FROM WASHER DISINFECTOR AQUADIS 56-SERIES, MODEL NAME 56M. THE ODOR LED TO HEALTH SYMPTOMS REPORTED BY STAFF INCLUDING COUGHING, SORE THROAT, AND BREATHING ISSUES. SEVERAL INDIVIDUALS REQUIRED MEDICAL TESTING AND TREATMENT. IN RESPONSE, THE UNIT WAS TAKEN OUT OF SERVICE.
Patient problems: Cough; Eye Pain; Sore Throat
MAUDE report 24774150 ↗InjuryJul 31, 2025Device Emits Odor; Device Emits Odor
GETINGE HAS BEEN AWARE ABOUT A CHEMICAL ODOR FROM WASHER DISINFECTOR AQUADIS 56-SERIES, MODEL NAME 56M. THE ODOR LED TO HEALTH SYMPTOMS REPORTED BY STAFF INCLUDING COUGHING, SORE THROAT, AND BREATHING ISSUES. SEVERAL INDIVIDUALS REQUIRED MEDICAL TESTING AND TREATMENT. IN RESPONSE, THE UNIT WAS TAKEN OUT OF SERVICE. REF # (B)(4).
Patient problems: Cough; Eye Pain; Sore Throat
MAUDE report 22677260 ↗InjuryJul 31, 2025Device Emits Odor; Device Emits Odor
MANUFACTURER'S REFERENCE NUMBER: (B)(4).
Patient problems: Cough; Eye Pain; Sore Throat
MAUDE report 22673837 ↗MalfunctionJul 26, 2024Device Damaged Prior to Receipt by User; Tear, Rip or Hole in Device Packaging; Device Damaged Prior to Receipt by User; Tear, Rip or Hole in Device Packaging
ON JULY 18TH, 2024 GETINGE BECAME AWARE OF OF AN ISSUE WITH GETINGE DISINFECTION AB WASHER DISINFECTOR AQUADIS 56M. THE ISSUE IS LINKED WITH PACKAGING OF THE AQUADIS 56M. AS IT WAS STATED, MACHINE OUTER PACKAGING WAS TORN AND THE PALLET WAS BROKEN. AQUADIS 56M HAS SLIPPED OUT FROM THE ORIGINAL PLACE IN PALLET DUE TO LEGS BEING NOT TIED OR SCREWED TO THE PALLET. THE CUSTOMER CLAIMS THAT THE GLASS DOOR WAS NOT COVERED. THE UNIT IS DAMAGED WITH BROKEN GLASS, DENTED HANDLE, DENTED PLATE, MISSING LEG PLATE, BENT PROGRAMMABLE LOGIC CONTROLLER PLATE AND MACHINE LOWER PANEL DISLOCATED. THERE WAS NO INJURY. NEVERTHELESS, WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION, AS WE CANNOT CONFIRM THAT SIMILAR EVENT WOULD NOT CONTRIBUTED TO THE SERIOUS INJURY IF REOCCURS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19836295 ↗
Other Disinfector, Medical Devices devices
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- GETINGE CM320-SERIESGetinge Disinfection AB · Disinfector, Medical Devices2 recalls1 report
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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