Defibtech, LLC: Medical Device Recall in 2025 - (Recall #: Z-1691-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

Automated External Defibrillators, Model DDU-2200, IItem numbers: DCF-E2210-D3/1¿(German/English dual language), DCF-E2210-F3/1¿(French/English dual language)

Product Classification:

Class II

Date Initiated: March 18, 2025

Date Posted: May 7, 2025

Recall Number: Z-1691-2025

Event ID: 96618

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).

Status: Ongoing

Product Quantity: 13 units (OUS only)

Code Information:

UDI-DIs; 00815098020195 (DDU-2200, export version), 10815098020192 (DDU-2200, export version (configuration level)); Lot numbers: 400184748, 400170814, 400180780, 400142381, 400142390, 400142995, 400145936, 400145955, 400149039, 400149042, 400149094, 400145977, 400149090,

Distribution Pattern:

International Only: Switzerland.

Voluntary or Mandated:

Voluntary: Firm initiated