Agency classClass IIOur severity:Low FDA (Devices)·Z-1690-2025·Announced 2025-05-07

Semi-Automated External Defibrillators Missing Italian Language Labeling

Defibtech is recalling semi-automated external defibrillators (Models DDU-100 and DDU-100E) distributed in Switzerland because they lack 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 1/5 (Low).

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: This is a labeling deficiency—specifically, missing translation into one of three required official languages—with no reported injuries or safety hazards. The issue is regulatory non-compliance regarding product documentation, not a device malfunction or health risk, consistent with FDA Class II cosmetic or documentation-level defects.

Plain-English summary

Defibtech, LLC is recalling semi-automated external defibrillators (AEDs), Models DDU-100 and DDU-100E, distributed internationally in Switzerland. The recalled units include item numbers DCF-E110SG-DE/1 (German), DCF-E110SG-FR/1 (French), and DCF-E110SG-IT/1 (Italian). A total of 43 units have been distributed.

The defibrillators were found to lack Italian language translation for product information, labeling, and instructions for use. Article 16 of the Swiss Medical Devices Ordinance (MedDO) requires that product information be provided in all three official languages of Switzerland: German, French, and Italian.

Defibtech has identified the affected lot numbers, which include 114008193, 114007350, 114007323, 114008190, 116012370, 116011831, and 36 additional lot numbers. If you have received one of these devices, contact Defibtech, LLC immediately.

The recalled product

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)
Manufacturer: Defibtech, LLC
Category: Medical Device — Defibrillator / AED
Hazard: mis-labeling
Affected units: 43

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 (20)

UDI-DIs: 00815098020034 (DDU-100
export version)
10815098020031 (DDU-100
export version (configuration level)). Lot numbers: 114008193
114007350
114007323
114008190
116012370
116011831
114006014
114006766
114006943
114007067
114007068
114007071
114007078
114007091
114007114
114007123
114007128

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.

See all 4 products in this recall →

Same manufacturer · Defibtech, LLC

See all →

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FDA (Devices) · 2025-05-07
Low
Automated External Defibrillators DDU-2200 Missing Italian Language Translation
FDA (Devices) · 2025-05-07
Moderate
Automated External Defibrillator Model DDU-2450 Missing Italian Translation
FDA (Devices) · 2025-05-07
Low
Defibtech Automated External Defibrillators Model DDU-2200 Missing Italian Translation
FDA (Devices) · 2025-05-07
High
Defibtech Adult Defibrillation Pads Recalled for Labeling Error Risk
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Same hazard · mis labeling