Automated External Defibrillators Model DDU-2200 Missing Required Italian Language Instructions
Defibtech Automated External Defibrillators (Model DDU-2200) distributed in Switzerland lack Italian language instructions, violating Swiss Medical Devices Ordinance requirements for three-language labeling.
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 medical device recall driven by a labeling compliance violation—missing Italian-language instructions required by Swiss Medical Devices Ordinance Article 16. No illnesses or injuries have been reported. This is a voluntary precautionary recall for a regulatory non-compliance issue rather than a documented patient safety incident, meeting the criterion for Moderate severity as a labeling error.
Plain-English summary
Defibtech, LLC initiated a recall of Automated External Defibrillators (Model DDU-2200) distributed internationally to Switzerland. These devices lack instructions in Italian, required under Article 16 of the Swiss Medical Devices Ordinance. Swiss law mandates that product labeling and instructions for use be available in all three official languages of Switzerland (German, French, and Italian). The affected devices are available in German/English and French/English versions only.
The recall affects 13 units distributed solely to Switzerland. Affected lot numbers include 400184748, 400170814, 400180780, 400142381, 400142390, 400142995, 400145936, 400145955, 400149039, 400149042, 400149094, 400145977, and 400149090. No illnesses or injuries have been reported.
Consumers or institutions in Switzerland who have received these devices should contact Defibtech, LLC to obtain proper Italian-language instructions or arrange for replacement units that include complete labeling in all required languages.
The recalled product
- Product
- Automated External Defibrillators, Model DDU-2200, IItem numbers: DCF-E2210-D3/1¿(German/English dual language), DCF-E2210-F3/1¿(French/English dual language)
- Manufacturer
- Defibtech, LLC
- Hazard
- mis-labeling
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 (18)
- UDI-DIs
- 00815098020195 (DDU-2200
- export version)
- 10815098020192 (DDU-2200
- export version (configuration level))
- Lot numbers: 400184748
- 400170814
- 400180780
- 400142381
- 400142390
- 400142995
- 400145936
- 400145955
- 400149039
- 400149042
- 400149094
- 400145977
- 400149090
Distribution
Distribution scope not specified by the agency.
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