Medical DeviceAug 20, 2025
Ambu SPUR II Labeled as the following: 1 SPUR II Adult Resuscitator, Adult recall — FDA Z-2181-2025
Potential for the manometer port being blocked rendering the manometer non-functional.
Class IFDA: OngoingAmbu Inc.
Recall history in this database
Classification mix: Class II: 5, Class I: 1.
Medical DeviceMay 14, 2025
Ambu aScope" 5 Broncho HD 5.6/2.8 Sampler Set recall — FDA Z-1723-2025
Incorrect labeling in which the front red pouch label did not match the actual size of the medical device. The label on the front of the scope incorrectly states 5.0/2.2 while the back…
Class IIFDA: OngoingAmbu Inc.
Medical DeviceNov 6, 2024
Ambu VivaSight 2 DLT Endobronchial tube, 35 FR (Catalog Number 412351000), 37 Fr recall — FDA Z-0261-2025
Ambu has received complaints on Ambu VivaSight 2 DLTs regarding hyper angulation of the distal end. The hyper angulation can lead to an increased risk of complications during intubation and…
Class IIFDA: OngoingAmbu Inc.
Medical DeviceJan 17, 2024
Ambu aView 2 A Monitor, Catalog numbers 405011000 and 405011000US2 recall — FDA Z-0714-2024
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…
Class IIFDA: OngoingAmbu Inc.
Medical DeviceOct 4, 2023
Ambu aView 2 A Monitor-The Ambu aView 2 Advance is intended to display live imaging data recall — FDA Z-2628-2023
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…
Class IIFDA: OngoingAmbu Inc.
Medical DeviceJul 27, 2022
Ambu VivaSight 2 DLT recall — FDA Z-1420-2022
Firm has received complaints on the device concerning leak/rupture of either the bronchial or tracheal cuff. Leakage during procedure could lead to loss of secure airway and will require…
Class IIFDA: OngoingAmbu Inc.
Understanding this recall history
This page summarizes recall records in which the official source identifies Ambu Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.