FDA Medical devices recall ·
Washer Disinfector Aquadis 56 recall
- Recall number
- Z-1720-2025
- Date
- (initiated April 2, 2025)
- Company / brand
- Getinge Disinfection Ab
Ljungadalsgatan 11, Vaxjo, N/A, Sweden - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 102 units (8 US, 94 OUS)
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Washer Disinfector Aquadis 56; Model Number: 56A
Why was it recalled?
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 should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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, WAA106820, WAA106835, WAA106841, WAA107693, WAA107428, WAA107429, WAA600055, WAA600060, WAA600061, WAA106607, WAA106668, WAA106753, WAA107358, WAA109804, WAA106793, WAA108419, WAA110679, WAA109022, WAA109030, WAA109564, WAA109566, WAA109595, WAA109598, WAA105283, WAA107346, WAA600188, WAA107314, WAA107330, WAA110062, WAA110075, WAA110084, WAA110104, WAA110163, WAA110302, WAA110201, WAA600558, WAA110953, WAA110963, WAA110138, WAA109975, WAA107281, WAA107303, WAA108972, WAA110228, WAA110162, WAA110727, WAA110738, WAA110742, WAA110803, WAA108669, WAA108670, WAA108673, WAA108722, WAA110762, WAA110631, WAA110636, WAA600167, WAA600168, WAA110482, WAA111159, WAA111170, WAA111183, WAA105284, WAA108615, WAA109514, WAA110174, WAA110178, WAA110898, WAA110907, WAA600077, WAA600177, WAA600338, WAA600339, WAA600340, WAA600341, WAA600342, WAA600343, WAA600344, WAA600394, WAA600705, WAA600706, WAA600711, WAA600712, WAA600713.
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, 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.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1720-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.