Ambu recalls

Ambu has 7 recalls on record with the FDA and USDA, the earliest in 2016 and the latest reported on 20 Aug 2025. 6 are still ongoing. The most frequent reason is lead & heavy metals.

Total recalls7since 2016

Last 12 months0reported

Class I114% of total

Ongoing6latest 20 Aug 2025

Recalls per month, last 24 months

click a bar for that month

0Oct '24 1 0 0Jan '25 0 0 0Apr 1 0 0Jul 1 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 1 14%Class II 6 86%Class III 0 0%

Why ambu is recalled

Product types

By year

2025229%
2024229%
2023114%
2022114%
2016114%

Ongoing ambu recalls

6 active

Reported	Class	Recall	Company	Reason	Where
20 Aug 2025Device	CLASS I	Spur II Labeled as the following recalled by Ambu	Ambu	Lead & Heavy Metals	Nationwide
14 May 2025Device	CLASS II	aScope" 5 Broncho HD 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	Lead & Heavy Metals	Nationwide
17 Jan 2024Device	CLASS II	aView 2 A Monitor recalled by Ambu	Ambu	Packaging Defects	Nationwide
4 Oct 2023Device	CLASS II	aView 2 A Monitor-The Ambu aView 2 Advance is intended to recalled	Ambu	Device Malfunction	Nationwide
27 Jul 2022Device	CLASS II	VivaSight 2 DLT recalled by Ambu	Ambu	Lead & Heavy Metals	Nationwide

All ambu recalls, newest first

7 total

Reported	Class	Recall	Company	Reason	Where
20 Aug 2025Device	CLASS I	Spur II Labeled as the following recalled by Ambu	Ambu	Lead & Heavy Metals	Nationwide
14 May 2025Device	CLASS II	aScope" 5 Broncho HD 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	Lead & Heavy Metals	Nationwide
17 Jan 2024Device	CLASS II	aView 2 A Monitor recalled by Ambu	Ambu	Packaging Defects	Nationwide
4 Oct 2023Device	CLASS II	aView 2 A Monitor-The Ambu aView 2 Advance is intended to recalled	Ambu	Device Malfunction	Nationwide
27 Jul 2022Device	CLASS II	VivaSight 2 DLT recalled by Ambu	Ambu	Lead & Heavy Metals	Nationwide
30 Mar 2016Device	CLASS II	Aura Gain - Single Use Laryngeal Mask- Sterile recalled by Ambu	Ambu	Sterility	MD

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.