Ambu Inc.: Medical Device Recall in 2024 - (Recall #: Z-0714-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

Ambu aView 2 A Monitor, Catalog numbers 405011000 and 405011000US2

Product Classification:

Class II

Date Initiated: December 5, 2023

Date Posted: January 17, 2024

Recall Number: Z-0714-2024

Event ID: 93599

Reason for Recall:

Instructions for Use have been updated to add the following warning: Use only M4 screws with the length of 14 16 mm when mounting Ambu aView 2 Advance on a VESA interface. Using longer screw lengths will penetrate the lithium-ion battery and result in a fire hazard and battery leakage which can cause severe burns, smoke inhalation and skin irritation. Using shorter screw lengths could result in unsecure device fastening.

Status: Ongoing

Product Quantity: 11845 distributed US

Code Information:

Catalog No. 405011000 - UDI-DI 5707480145089 Catalog No. 405011000US2 - UDI-DI 5707480156757 All products distributed since launch (May 2020)

Distribution Pattern:

Domestic distribution nationwide.

Voluntary or Mandated:

Voluntary: Firm initiated