# FDA recall Z-1691-2025

> **Defibtech, LLC** · Class II · device recall initiated 2025-03-18.

## 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)

## 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).

## Distribution

International Only: Switzerland.

## Key facts

- **Recall number:** Z-1691-2025
- **Recalling firm:** Defibtech, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-03-18
- **Report date:** 2025-05-07

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Guilford, CT, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1691-2025

## Citation

> AI Analytics. FDA recall Z-1691-2025. Retrieved 2026-06-30 from https://api.ai-analytics.org/recall/Z-1691-2025. Source: US FDA. Licensed CC0.

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