The Recall Desk
HighFDA (Devices)·Z-1690-2025·Announced 2025-05-07

[pending] Semi-Automated External Defibrillators; Models: DDU-100 and DDU-100E. Item numbers: DCF-E110SG-DE/1

Pending LLM rewrite. Source: FDA_DEVICE Z-1690-2025.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Pending LLM scoring against the rubric.

Plain-English summary

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 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 — Devices

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.

Related recalls

Same category