Semi-Automated External Defibrillators — Class II medical device recall Z-1690-2025

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-1690-2025`
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	43 units
UPC / GTIN / UDI-DI	`00815098020034`, `10815098020031`
Lot numbers	`104016266`, `104016297`, `114006014`, `114006766`, `114006943`, `114007067`, `114007068`, `114007071`, `114007078`, `114007091`, `114007114`, `114007123`, `114007128`, `114007137`, `114007145`, `114007323`, `114007350`, `114007478`, `114007486`, `114007517`, `114007623`, `114007696`, `114007705`, `114007770`, `114007906`, `114007907`, `114007911`, `114007914`, `114007925`, `114007933`, `114007934`, `114007964`, `114008190`, `114008193`, `116011703`, `116011708`, `116011831`, `116011883`, `116012370`, `116012476` and 3 more
Model numbers	`DCF-E110SG-DE/1`, `DDU-100`, `DDU-100E`

Product

Semi-Automated External Defibrillators; Models: DDU-100 and DDU-100E. Item numbers: DCF-E110SG-DE/1 (German language), DCF-E110SG-FR/1 (French language), DCF-E110SG-IT/1 (Italian 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-1690-2025. 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.