The Recall Desk
HighFDA (Devices)·Z-1720-2025·Announced 2025-05-14

Washer Disinfector Aquadis 56 Recalled for Premature Pump Seal Wear

Getinge Disinfection is recalling the Aquadis 56 washer disinfector due to improper frequency inverter programming that causes the circulation pump to start prematurely, resulting in accelerated wear on the axial seal.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall of a medical device with no reported injuries or illnesses. The hazard is a risk-of-harm mechanism—premature mechanical wear that could lead to equipment malfunction—but no actual harm has been reported. Per the rubric, such recalls score at most 3 (High).

Plain-English summary

The Aquadis 56 washer disinfector (Model 56A) is being recalled by its manufacturer, Getinge Disinfection Ab. A total of 102 units have been distributed worldwide, including 8 units in the United States.

The device contains a frequency inverter that controls the circulation pump. Due to incorrect programming, the pump starts earlier than specified, causing accelerated wear and tear on the axial seal in the pump housing. This premature wear could lead to equipment malfunction or failure.

No injuries or illnesses have been reported to date. Healthcare facilities using affected units with the listed serial numbers should contact their service representatives for guidance on remediation or device replacement.

The recalled product

Product
Washer Disinfector Aquadis 56; Model Number: 56A
Manufacturer
Getinge Disinfection Ab
Hazard
  • equipment-malfunction
  • seal-failure

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • Model: 56A
  • UDI-DI: 07340153710344
  • Serial Numbers: WAA104857
  • WAA107934
  • WAA107937
  • WAA108359
  • WAA108540
  • WAA108963
  • WAA109338
  • WAA110115
  • WAA108201
  • WAA109175
  • WAA109884
  • WAA109989
  • WAA109998
  • WAA110804
  • WAA600035
  • WAA109641
  • WAA109651
  • WAA111118

Distribution

Distributed nationwide across the United States.