The Recall Desk

FDA (Devices) recall action 96618

Defibtech, LLC recalled 4 products on 2025-05-07

The FDA (Devices) publishes a recall like this one as 4 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 4 pages.

Products
4
Announced
2025-05-07
Critical
0
Units
269

Why these products were recalled

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).

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–4 of 4

  • LowFDA (Devices)··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.

    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)
    Category
    Distribution
    0 states
  • LowFDA (Devices)··2025-05-07

    Automated External Defibrillators DDU-2200 Missing Italian Language Translation

    Defibtech is recalling Automated External Defibrillators Model DDU-2200 distributed in Switzerland because they lack required Italian language labeling and instructions for use.

    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)
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2025-05-07

    Defibtech Automated External Defibrillators Model DDU-2300 Recalled

    Defibtech is recalling Automated External Defibrillators Model DDU-2300 distributed in Switzerland because Italian-language labeling and instructions were not included, violating Swiss Medical Devices Ordinance requirements.

    Product
    Automated External Defibrillators, Model DDU-2300. Item numbers: DCF-E2310D3/1¿(German/English dual language), DCF-E2310E3/1¿(German/French dual language), DCF-E2310F3/1¿ (French/English dual language), DCF-E2310G3/1¿(French/German dual language), DCF-E2310IT (Italian language)
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2025-05-07

    Automated External Defibrillator Model DDU-2450 Missing Italian Translation

    Defibtech, LLC is recalling one Automated External Defibrillator Model DDU-2450 (German language version) distributed in Switzerland because it lacks required Italian language labeling and instructions for use.

    Product
    Automated External Defibrillators, Model DDU-2450. Item number: DCF-E2460DE (German language)
    Category
    Distribution
    0 states