Defibtech Automated External Defibrillators Model DDU-2300 Recalled
Defibtech is recalling Automated External Defibrillators Model DDU-2300 distributed in Switzerland because Italian-language labeling and instructions were not included, violating Swiss Medical Devices Ordinance requirements.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall involving a labeling deficiency. The source does not report any illnesses, injuries, or device failures; the hazard is non-compliance with regulatory labeling requirements rather than a safety or performance defect in the device itself.
Plain-English summary
Defibtech, LLC is recalling Automated External Defibrillators Model DDU-2300 (item numbers DCF-E2310D3/1, DCF-E2310E3/1, DCF-E2310F3/1, DCF-E2310G3/1, and DCF-E2310IT) distributed in Switzerland. The recall affects 212 units.
The device was recalled because product information, including labeling and instructions for use, was not provided in Italian, one of Switzerland's three official languages. Article 16 of the Swiss Medical Devices Ordinance (MedDO) requires that product information be provided in all three official languages: German, French, and Italian.
Healthcare facilities and users who have received affected units should contact Defibtech, LLC for further instructions. The specific lot numbers affected are listed in the FDA recall notice Z-1692-2025.
The recalled product
- 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)
- Manufacturer
- Defibtech, LLC
- Hazard
- labeling-deficiency
- missing-translation
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)
- 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
Distribution
Distribution scope not specified by the agency.
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