Food, drugs, devices › Getinge Disinfection Ab
Device recall: Washer Disinfector Aquadis 56; Model Number: 56A
Getinge Disinfection Ab (Vaxjo, N/A) initiated this device recall on 2 Apr 2025; FDA lists 2 product records under event 96644, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 85% of the 945 device enforcement events initiated in 2025 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. Getinge Disinfection Ab has 5 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Getinge Disinfection Ab, Vaxjo, N/A, Sweden.
Reason for recall
"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."
Distribution
"Worldwide distribution - US Nationwide and the countries of Australia, Austria, Bahrain, Bangladesh, Brazil, Canada, China, Colombia, Costa Rica, Cote d'Ivoire, Croatia, Cyprus, Czech Republic,…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1720-2025 | Washer Disinfector Aquadis 56; Model Number: 56A | 102 units (8 US, 94 OUS) | Class II | Ongoing | 14 May 2025 |
| Z-1721-2025 | Washer Disinfector Aquadis 56; Model Number: 56M | 424 units (79 US, 345 OUS) | Class II | Ongoing | 14 May 2025 |
Context
Other enforcement events for Getinge Disinfection Ab
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 29 Aug 2025 | Getinge 88-Series Washer- Disinfector. Model Number: 88-5. | Device | Class II | 1 |
| 2 Mar 2018 | Getinge AGS, FSLC, FSUC, RC accessory to Washer- Disinfector 86 Series UDI Info: 86 Series Washer Disinfector 0734015370 | Device | Class II | 2 |
| 26 Jun 2015 | Getinge 86 Series Washer/Disinfector with G1 control system software, Model 8666 and Model 8668. For use in healthcare f | Device | Class III | 1 |
| 26 Nov 2014 | GETINGE 46-SERIES Medical Washer-Disinfector, Models 46-4 and 46-5, with PACS 300/350 Control Series with dryer --- Clas | Device | Class II | 1 |
All 5 events for Getinge Disinfection Ab
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "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."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide distribution - US Nationwide and the countries of Australia, Austria, Bahrain, Bangladesh, Brazil, Canada, China, Colombia, Costa Rica, Cote d'Ivoire, Croatia, Cyprus, Czech Republic,…"
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.