CLASS II ONGOING Device recall · Reported 4 Oct 2023 · FDA Enforcement Report

aView 2 A Monitor-The Ambu aView 2 Advance is intended recalled

Ambu is recalling aView 2 A Monitor-The Ambu aView 2 Advance is intended to display live imaging data from, distributed nationwide in the US. The recall was initiated on 21 Jul 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI: 5707480145089 Version no.: 054 thru 056; 058 thru 059 Product manufactured prior to Oct 29, 2020

Quantity recalled2689 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2628-2023
FDA event ID: 92886
Recalling firm: Ambu, Columbia, MD
Classification: Class II
Status: Ongoing
Recall initiated: 21 Jul 2023
FDA classified: 22 Sep 2023
Reported: 4 Oct 2023
Type: Voluntary: Firm initiated
Customers notified by: Visit
Reason category: Device Malfunction
Device type: Surgical Instruments

Timeline

21 Jul 2023	Recall initiated by company
22 Sep 2023	Classified by FDA	+63 days
4 Oct 2023	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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

Where it was distributed

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

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

Where was it sold?

Nationwide

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Ambu

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20 Aug 2025Device	CLASS I	Spur II Labeled as the following recalled by Ambu	Ambu	Other	Nationwide
14 May 2025Device	CLASS II	aScope" 5 Broncho HD 5.6/2.8 Sampler Set recalled by Ambu	Ambu	Labeling Errors	Nationwide
6 Nov 2024Device	CLASS II	Ambu¿ VivaSight 2 DLT Endobronchial tube recalled	Ambu	Other	Nationwide
17 Jan 2024Device	CLASS II	aView 2 A Monitor recalled by Ambu	Ambu	Packaging Defects	Nationwide
27 Jul 2022Device	CLASS II	VivaSight 2 DLT recalled by Ambu	Ambu	Packaging Defects	Nationwide

Other Surgical Instruments recalls

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Reported	Class	Recall	Company	Reason	Where
14 Oct 2026Device	CLASS II	Adaptable Beach Chair Beach Chair surgical patient positioner recalled	Quantum OPS	Device Malfunction	Nationwide
14 Oct 2026Device	CLASS II	Laparoscopic Prostatectomy kits recalled by Avid Medical	Avid Medical	Other	Nationwide
14 Oct 2026Device	CLASS II	Halyard Laparoscopy Comprehensive Pack II recalled	GRI Medical & Electronic Technology	Other	Nationwide
14 Oct 2026Device	CLASS II	Gyn Laparoscopy/Laparotomy kits recalled by Avid Medical	Avid Medical	Other	Nationwide
14 Oct 2026Device	CLASS II	Gyn Laparoscopy Pack kits recalled by Avid Medical	Avid Medical	Other	Nationwide