Ambu Inc.: Medical Device Recall in 2023 - (Recall #: Z-2628-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

Ambu aView 2 A Monitor-The Ambu aView 2 Advance is intended to display live imaging data from compatible Ambu visualization devices, portable endoscopy system. Catalog No: 405011000

Product Classification:

Class II

Date Initiated: July 21, 2023

Date Posted: October 4, 2023

Recall Number: Z-2628-2023

Event ID: 92886

Reason for Recall:

Multiple impacts, for example from being dropped, can cause to the Ambu aView 2 Advance to short-circuit and under special circumstances make the lithium-ion battery in the device combust leading to smoke and flames

Status: Ongoing

Product Quantity: 2689 units

Code Information:

UDI: 5707480145089 Version no.: 054 thru 056; 058 thru 059 Product manufactured prior to Oct 29, 2020

Distribution Pattern:

Nationwide

Voluntary or Mandated:

Voluntary: Firm initiated