CLASS II ONGOING Device recall · Reported 14 May 2025 · FDA Enforcement Report

Washer Disinfector Aquadis recalled by Getinge Disinfection Ab

Getinge Disinfection Ab is recalling Washer Disinfector Aquadis 56, distributed nationwide in the US. The recall was initiated on 2 Apr 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel: 56M; UDI-DI: 07340153710351; Serial Numbers: WAA105199, WAA105251, WAA105268, WAA105357, WAA105535, WAA105700, WAA105915, WAA105972, WAA105973, WAA106079, WAA106114, WAA106135, WAA106451, WAA106471, WAA106487, WAA106505, WAA107436, WAA107492, WAA107565, WAA107581, WAA107588, WAA107920, WAA108225, WAA108807, WAA108920, WAA108921, WAA108922, WAA109036, WAA109047, WAA109231, WAA109377, WAA109392, WAA109635, WAA109687, WAA109731, WAA109790, WAA109835, WAA109840, WAA109853, WAA109907, WAA109972, WAA110109, WAA110366, WAA110487, WAA110546, WAA110557, WAA110711, WAA110726, WAA110802, WAA110847, WAA110862, WAA110984, WAA110999, WAA111007, WAA111011, WAA111068, WAA111086, WAA111087, WAA111200, WAA600033, WAA600054, WAA600100, WAA600102, WAA600103, WAA600145, WAA600190, WAA600282, WAA600369, WAA600431, WAA600434, WAA600444, WAA600445, WAA600553, WAA600554, WAA600587, WAA600588, WAA600609, WAA600610, WAA600704, WAA106987, WAA110250, WAA110257, WAA108634, WAA110823, WAA108206, WAA109799, WAA109066, WAA109076, WAA109091, WAA109373, WAA110528, WAA111028, WAA600134, WAA600189, WAA110820, WAA110123, WAA108871, WAA108872, WAA106724, WAA109403, WAA109405, WAA109495, WAA109933, WAA110513, WAA110527, WAA110617, WAA109658, WAA109672, WAA110029, WAA110779, WAA110893, WAA107614, WAA108608, WAA108610, WAA109222, WAA109764, WAA109782, WAA109946, WAA110055, WAA110083, WAA110204, WAA110801, WAA600066, WAA600068, WAA600072, WAA600507, WAA600508, WAA106520, WAA106618, WAA106639, WAA110594, WAA110595, WAA110842, WAA111150, WAA600105, WAA108702, WAA108040, WAA106692, WAA107486, WAA107491, WAA108832, WAA108998, WAA109241, WAA109244, WAA109885, WAA110167, WAA110279, WAA110290, WAA110303, WAA110349, WAA110394, WAA110406, WAA111093, WAA111098, WAA111112, WAA600216, WAA600441, WAA600509, WAA600560, WAA600611, WAA600612, WAA600613, WAA600648, WAA107279, WAA107940, WAA109140, WAA109973, WAA110534, WAA110545, WAA111142, WAA111174, WAA111177, WAA111185, WAA106240, WAA106760, WAA110566, WAA110876, WAA108501, WAA108502, WAA108514, WAA109093, WAA109409, WAA109805, WAA109808, WAA109966, WAA110032, WAA110037, WAA110618, WAA600141, WAA600220, WAA600221, WAA600222, WAA600223, WAA600253, WAA600254, WAA600255, WAA600450, WAA600451, WAA600585, WAA600586, WAA110881, WAA105641, WAA105682, WAA106980, WAA107125, WAA108151, WAA108367, WAA108394, WAA108519, WAA108531, WAA108953, WAA109653, WAA109874, WAA110018, WAA110027, WAA110056, WAA110327, WAA111114, WAA600106, WAA600186, WAA600187, WAA107148, WAA107232, WAA107267, WAA107307, WAA107360, WAA107418, WAA108067, WAA108136, WAA108137, WAA108161, WAA108170, WAA108217, WAA108409, WAA108479, WAA108499, WAA108500, WAA108653, WAA108743, WAA108745, WAA108746, WAA108863, WAA108864, WAA109187, WAA109199, WAA109200, WAA109207, WAA109269, WAA109278, WAA109285, WAA109305, WAA109309, WAA109314, WAA109327, WAA109497, WAA109501, WAA109507, WAA109565, WAA110208, WAA110226, WAA110361, WAA110643, WAA110836, WAA110845, WAA110937, WAA110938, WAA111012, WAA111032, WAA111055, WAA600047, WAA600053, WAA600135, WAA600256, WAA600286, WAA600287, WAA600288, WAA600370, WAA600371, WAA600436, WAA600438, WAA600442, WAA600446, WAA600448, WAA600555, WAA110297, WAA110315, WAA107182, WAA109948, WAA110950, WAA110268, WAA110648, WAA110663, WAA107190, WAA107199, WAA109370, WAA109513, WAA110486, WAA106247, WAA106399, WAA106412, WAA108983, WAA110013, WAA110420, WAA600217, WAA600649, WAA600858, WAA109765, WAA109696, WAA109713, WAA109737, WAA109182, WAA109673, WAA109686, WAA109862, WAA109864, WAA110256, WAA110274, WAA110460, WAA109949, WAA106546, WAA106548, WAA107084, WAA107905, WAA108894, WAA109343, WAA109352, WAA109393, WAA109908, WAA109931, WAA110686, WAA110833, WAA111083, WAA600218, WAA600219, WAA600278, WAA600556, WAA107522, WAA107594, WAA108973, WAA108975, WAA110638, WAA111052, WAA111053, WAA111186, WAA111189, WAA110395, WAA107136, WAA110323, WAA110338, WAA110360, WAA110370, WAA107215, WAA106992, WAA108059, WAA108623, WAA110703, WAA105696, WAA107624, WAA107641, WAA107691, WAA107699, WAA107731, WAA107736, WAA107746, WAA107756, WAA107763, WAA107788, WAA107790, WAA107801, WAA107804, WAA107806, WAA107825, WAA107829, WAA107858, WAA107860, WAA107883, WAA107897, WAA108226, WAA108264, WAA108267, WAA108300, WAA108301, WAA108410, WAA108466, WAA108952, WAA109249, WAA109260, WAA109261, WAA109266, WAA109340, WAA109688, WAA109757, WAA109937, WAA110374, WAA110428, WAA110432, WAA110452, WAA110453, WAA600011, WAA600082, WAA600101, WAA600104, WAA600107, WAA600129, WAA600130, WAA600285, WAA600551, WAA600552, WAA600559, WAA109920, WAA109929, WAA600280, WAA600281, WAA110756, WAA110757, WAA109631, WAA109916, WAA110235, WAA110248, WAA600289, WAA600327, WAA110154, WAA600650, WAA107607.

Quantity recalled424 units (79 US, 345 OUS)

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1721-2025
FDA event ID: 96644
Recalling firm: Getinge Disinfection Ab, Vaxjo, N/A
Classification: Class II
Status: Ongoing
Recall initiated: 2 Apr 2025
FDA classified: 5 May 2025
Reported: 14 May 2025
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Other Medical Devices

Timeline

2 Apr 2025	Recall initiated by company
5 May 2025	Classified by FDA	+33 days
14 May 2025	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

Washer Disinfector Aquadis 56; Model Number: 56M

Where it was distributed

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, Denmark, Ecuador, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Italy, Japan, Kenya, Korea, Kuwait, Latvia, Lithuania, Malaysia, Mauritania, Mexico, Netherlands, New Caledonia, Nigeria, Norway, Oman, Pakistan, Philippines, Poland, Romania, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, Spain, Sweden, Switzerland, Syria, Thailand, Turkey, Turkmenistan, United Arab Emirates, United Kingdom, Vietnam, Zambia.

Nationwide

Questions about this recall

Is Washer Disinfector Aquadis 56 recalled?

Yes. Getinge Disinfection Ab recalled Washer Disinfector Aquadis 56 on 2 Apr 2025. The recall is Class II and its status is Ongoing. Recall number Z-1721-2025.

Why was it recalled?

Which lots are affected?

Model: 56M; UDI-DI: 07340153710351; Serial Numbers: WAA105199, WAA105251, WAA105268, WAA105357, WAA105535, WAA105700, WAA105915, WAA105972, WAA105973, WAA106079, WAA106114, WAA106135, WAA106451, WAA106471, WAA106487, WAA106505, WAA107436, WAA107492, WAA107565, WAA107581, WAA107588, WAA107920, WAA108225, WAA108807, WAA108920, WAA108921, WAA108922, WAA109036, WAA109047, WAA109231, WAA109377, WAA109392, WAA109635, WAA109687, WAA109731, WAA109790, WAA109835, WAA109840, WAA109853, WAA109907, WAA109972, WAA110109, WAA110366, WAA110487, WAA110546, WAA110557, WAA110711, WAA110726, WAA110802, WAA110847, WAA110862, WAA110984, WAA110999, WAA111007, WAA111011, WAA111068, WAA111086, WAA111087, WAA111200, WAA600033, WAA600054, WAA600100, WAA600102, WAA600103, WAA600145, WAA600190, WAA600282, WAA600369, WAA600431, WAA600434, WAA600444, WAA600445, WAA600553, WAA600554, WAA600587, WAA600588, WAA600609, WAA600610, WAA600704, WAA106987, WAA110250, WAA110257, WAA108634, WAA110823, WAA108206, WAA109799, WAA109066, WAA109076, WAA109091, WAA109373, WAA110528, WAA111028, WAA600134, WAA600189, WAA110820, WAA110123, WAA108871, WAA108872, WAA106724, WAA109403, WAA109405, WAA109495, WAA109933, WAA110513, WAA110527, WAA110617, WAA109658, WAA109672, WAA110029, WAA110779, WAA110893, WAA107614, WAA108608, WAA108610, WAA109222, WAA109764, WAA109782, WAA109946, WAA110055, WAA110083, WAA110204, WAA110801, WAA600066, WAA600068, WAA600072, WAA600507, WAA600508, WAA106520, WAA106618, WAA106639, WAA110594, WAA110595, WAA110842, WAA111150, WAA600105, WAA108702, WAA108040, WAA106692, WAA107486, WAA107491, WAA108832, WAA108998, WAA109241, WAA109244, WAA109885, WAA110167, WAA110279, WAA110290, WAA110303, WAA110349, WAA110394, WAA110406, WAA111093, WAA111098, WAA111112, WAA600216, WAA600441, WAA600509, WAA600560, WAA600611, WAA600612, WAA600613, WAA600648, WAA107279, WAA107940, WAA109140, WAA109973, WAA110534, WAA110545, WAA111142, WAA111174, WAA111177, WAA111185, WAA106240, WAA106760, WAA110566, WAA110876, WAA108501, WAA108502, WAA108514, WAA109093, WAA109409, WAA109805, WAA109808, WAA109966, WAA110032, WAA110037, WAA110618, WAA600141, WAA600220, WAA600221, WAA600222, WAA600223, WAA600253, WAA600254, WAA600255, WAA600450, WAA600451, WAA600585, WAA600586, WAA110881, WAA105641, WAA105682, WAA106980, WAA107125, WAA108151, WAA108367, WAA108394, WAA108519, WAA108531, WAA108953, WAA109653, WAA109874, WAA110018, WAA110027, WAA110056, WAA110327, WAA111114, WAA600106, WAA600186, WAA600187, WAA107148, WAA107232, WAA107267, WAA107307, WAA107360, WAA107418, WAA108067, WAA108136, WAA108137, WAA108161, WAA108170, WAA108217, WAA108409, WAA108479, WAA108499, WAA108500, WAA108653, WAA108743, WAA108745, WAA108746, WAA108863, WAA108864, WAA109187, WAA109199, WAA109200, WAA109207, WAA109269, WAA109278, WAA109285, WAA109305, WAA109309, WAA109314, WAA109327, WAA109497, WAA109501, WAA109507, WAA109565, WAA110208, WAA110226, WAA110361, WAA110643, WAA110836, WAA110845, WAA110937, WAA110938, WAA111012, WAA111032, WAA111055, WAA600047, WAA600053, WAA600135, WAA600256, WAA600286, WAA600287, WAA600288, WAA600370, WAA600371, WAA600436, WAA600438, WAA600442, WAA600446, WAA600448, WAA600555, WAA110297, WAA110315, WAA107182, WAA109948, WAA110950, WAA110268, WAA110648, WAA110663, WAA107190, WAA107199, WAA109370, WAA109513, WAA110486, WAA106247, WAA106399, WAA106412, WAA108983, WAA110013, WAA110420, WAA600217, WAA600649, WAA600858, WAA109765, WAA109696, WAA109713, WAA109737, WAA109182, WAA109673, WAA109686, WAA109862, WAA109864, WAA110256, WAA110274, WAA110460, WAA109949, WAA106546, WAA106548, WAA107084, WAA107905, WAA108894, WAA109343, WAA109352, WAA109393, WAA109908, WAA109931, WAA110686, WAA110833, WAA111083, WAA600218, WAA600219, WAA600278, WAA600556, WAA107522, WAA107594, WAA108973, WAA108975, WAA110638, WAA111052, WAA111053, WAA111186, WAA111189, WAA110395, WAA107136, WAA110323, WAA110338, WAA110360, WAA110370, WAA107215, WAA106992, WAA108059, WAA108623, WAA110703, WAA105696, WAA107624, WAA107641, WAA107691, WAA107699, WAA107731, WAA107736, WAA107746, WAA107756, WAA107763, WAA107788, WAA107790, WAA107801, WAA107804, WAA107806, WAA107825, WAA107829, WAA107858, WAA107860, WAA107883, WAA107897, WAA108226, WAA108264, WAA108267, WAA108300, WAA108301, WAA108410, WAA108466, WAA108952, WAA109249, WAA109260, WAA109261, WAA109266, WAA109340, WAA109688, WAA109757, WAA109937, WAA110374, WAA110428, WAA110432, WAA110452, WAA110453, WAA600011, WAA600082, WAA600101, WAA600104, WAA600107, WAA600129, WAA600130, WAA600285, WAA600551, WAA600552, WAA600559, WAA109920, WAA109929, WAA600280, WAA600281, WAA110756, WAA110757, WAA109631, WAA109916, WAA110235, WAA110248, WAA600289, WAA600327, WAA110154, WAA600650, WAA107607.

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Getinge Disinfection Ab

All 7

Reported	Class	Recall	Company	Reason	Where
8 Oct 2025Device	CLASS II	Getinge 88-Series Washer- Disinfector recalled	Getinge Disinfection Ab	Device Malfunction	Nationwide
14 May 2025Device	CLASS II	Washer Disinfector Aquadis recalled by Getinge Disinfection Ab	Getinge Disinfection Ab	Packaging Defects	Nationwide
25 Apr 2018Device	CLASS II	Getinge Ags, Fslc, Fsuc, RC accessory to Washer recalled	Getinge Disinfection Ab	Other	Nationwide
25 Apr 2018Device	CLASS II	Getinge Ags, Fslc, Fsuc, RC accessory to Washer recalled	Getinge Disinfection Ab	Other	Nationwide
26 Aug 2015Device	CLASS III	Getinge 86 Series Washer/Disinfector with G1 control system recalled	Getinge Disinfection Ab	Foreign Material	12 states

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