Automated External Defibrillators — Class II medical device recall Z-1693-2025
Ongoing recall by Defibtech, LLC, reported 2025-05-07. It was noticed there was no Italian translation included for the AED. Article 16 of the Swiss Medical Devices
| Recall number | Z-1693-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Defibtech, LLC, Guilford, CT, United States |
| Recall initiated | 2025-03-18 |
| Classified | 2025-04-29 |
| Reported by FDA | 2025-05-07 |
| Countries outside the US | CH |
| Quantity | 1 units |
| UPC / GTIN / UDI-DI | 00815098020317, 10815098020314 |
| Lot numbers | 400188859 |
| Model numbers | DCF-E2460DE, DDU-2450 |
Product
Automated External Defibrillators, Model DDU-2450. Item number: DCF-E2460DE (German language)
Reason for recall
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).
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1693-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.