Ambu Inc. Ambu aView 2 A Monitor, Catalog numbers 405011000 and 405011000US2 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Ambu aView 2 A Monitor, Catalog numbers 405011000 and 405011000US2
Brand
Ambu Inc.
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
Catalog No. 405011000 - UDI-DI 5707480145089 Catalog No. 405011000US2 - UDI-DI 5707480156757 All products distributed since launch (May 2020)
Ambu Inc. is recalling Ambu aView 2 A Monitor, Catalog numbers 405011000 and 405011000US2 due to 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 Advan. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
On December 5, 2023, the firm began notifying their customers via Urgent Field Safety Notice (Correction) letters. Customers were provided with an insert of Instructions for Use to include with their Instructions for Use booklet that highlights the new warning. Should you have additional questions, please contact Sanjay Parikh (sap@ambu.com) or Tammy Feyerherm (tfey@ambu.com).
Verify this information on the official source
This page aggregates publicly available data. Always confirm recall details directly with the U.S. Food and Drug Administration (FDA) before taking action.
View official FDA recall noticePage updated: Jan 10, 2026
Important Notice
This page displays information sourced from the U.S. Food and Drug Administration (FDA). IsMyProductRecalled.com aggregates public data for convenience and does not issue recalls. We are not affiliated with any government agency. Always verify recall information with the official source before taking action. This is not medical or legal advice.