FDA Medical devices recall ·
Automated External Defibrillators, Model DDU-2300… recall
- Recall number
- Z-1692-2025
- Date
- (initiated March 18, 2025)
- Company / brand
- Defibtech, LLC
741 Boston Post Rd Ste 201, Guilford, CT, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 212 units (OUS only)
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Automated External Defibrillators, Model DDU-2300. Item numbers: DCF-E2310D3/1¿(German/English dual language), DCF-E2310E3/1¿(German/French dual language), DCF-E2310F3/1¿ (French/English dual language), DCF-E2310G3/1¿(French/German dual language), DCF-E2310IT (Italian language)
Why was it recalled?
It was noticed there was no Italian translation included for the AED. Article 16 of the Swiss Medical Devices Ordinance (MedDO) states that product information (labelling and instructions for use) should be provided in all three official languages of Switzerland (German, French, and Italian).
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
UDI-DIs: 00815098020232 (DDU-2300, export version), 10815098020239 (DDU-2300, export version (configuration level)). Lot numbers: 400174411, 400174755, 400175965, 400179100, 400179205, 400179279, 400179223, 400179206, 400179271, 400191481, 400191516, 400197352, 400191375, 400164982, 400155836, 400159075, 400139521, 400168419, 400160156, 400165319, 400190176, 400187549, 400187582, 400190198, 400186761, 400187569, 400150859, 400150811, 400187620, 400150948, 400182206, 400152805, 400200222, 400173689, 400173695, 400170424, 400182464, 400191479, 400179417, 400179733, 400168929, 400179607, 400179275, 400191478, 400151695, 400151696, 400151699, 400151718, 400151724, 400151727, 400151728, 400151730, 400151756, 400151799, 400151802, 400151812, 400151841, 400151843, 400151844, 400151858, 400151905, 400151907, 400151915, 400151920, 400156160, 400186774, 400187567, 400187593, 400187596, 400190090, 400190232, 400190280, 400190303, 400190304, 400190305, 400190318, 400190322, 400190324, 400190355, 400151697, 400151723, 400151851, 400151852, 400151916, 400154576, 400154581, 400154589, 400154595, 400154601, 400154645, 400154646, 400154698, 400154755, 400154839, 400157339, 400157485, 400157486, 400157489, 400157490, 400157510, 400157512, 400157514, 400157516, 400157521, 400150824, 400150860, 400150932, 400141200, 400141209, 400141210, 400141239, 400141257, 400141260, 400141266, 400141275, 400148165, 400148173, 400148186, 400148208, 400148213, 400148247, 400148275, 400150548, 400150839, 400150
Distribution
International Only: Switzerland.
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-1692-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.