Automated External Defibrillator Model DDU-2450 Missing Italian Translation
Defibtech, LLC is recalling one Automated External Defibrillator Model DDU-2450 (German language version) distributed in Switzerland because it lacks required Italian language labeling and instructions for use.
The agency’s classification
FDA (Devices): Class II
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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 a FDA Class II recall involving missing regulatory labeling (Italian translation) required by Swiss law. There are no reported illnesses or injuries, and the hazard is a labeling/documentation deficiency rather than a product safety defect, making it a moderate-severity recall.
Plain-English summary
Defibtech, LLC is recalling an Automated External Defibrillator Model DDU-2450 with item number DCF-E2460DE (German language) distributed in Switzerland. The product information, including labeling and instructions for use, does not include Italian translation.
The Swiss Medical Devices Ordinance (Article 16) requires that product information for medical devices be provided in all three official languages of Switzerland: German, French, and Italian. The recalled unit was distributed internationally to Switzerland only.
Consumers who have this device should contact Defibtech, LLC regarding the missing Italian language materials to ensure full compliance with Swiss regulatory requirements.
The recalled product
- Product
- Automated External Defibrillators, Model DDU-2450. Item number: DCF-E2460DE (German language)
- Manufacturer
- Defibtech, LLC
- Category
- Medical Device — Defibrillator
- Affected units
- 1
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 (4)
- UDI-DIs: 00815098020317 (DDU-2450
- export version)
- 10815098020314 (DDU-2450
- export version (configuration level)). Lot number: 400188859.
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 4 recalled by Defibtech, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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