FDA recall record · openFDA

Ambu Inc.

5 FDA recalls on record (2023–2025) — 5 device. 5 still ongoing.

Class I (most serious)

Class II

Class III

ongoing

How to read this. A recall count is not a quality verdict — large manufacturers recall more simply by volume, and a voluntary recall is the safety system working as intended. The signal to weight is the Class I count (the FDA's most-serious tier — reasonable probability of serious harm or death) and whether recalls are still ongoing. Most recalls are Class II/III. "Ongoing" reflects openFDA's last-published status — device recalls often stay marked ongoing long after they're resolved in practice; confirm current status at the FDA.

Most common reasons

Potential for the manometer port being blocked rendering the manometer non-functional. 1

Multiple impacts, for example from being dropped, can cause to the Ambu aView 2 Advance to short-circuit and under speci 1

Ambu has received complaints on Ambu¿ VivaSight 2 DLTs regarding hyper angulation of the distal end. The hyper angulatio 1

Instructions for Use have been updated to add the following warning: Use only M4 screws with the length of 14 16 mm wh 1

Incorrect labeling in which the front red pouch label did not match the actual size of the medical device. The label on 1

Recalls

Ambu SPUR II Labeled as the following: 1 SPUR II Adult Resuscitator, Adult, Catalog Number: 523211000 2 SPUR II Adult Re Class I 2025-07-09 Ambu aScope" 5 Broncho HD 5.6/2.8 Sampler Set. Model Number: 622002000US Class II 2025-04-07 Ambu¿ VivaSight 2 DLT Endobronchial tube, 35 FR (Catalog Number 412351000), 37 Fr (Catalog Number 412371000), 39 Fr (Cat Class II 2024-09-16 Ambu aView 2 A Monitor-The Ambu aView 2 Advance is intended to display live imaging data from compatible Ambu visualizat Class II 2023-07-21 Ambu aView 2 A Monitor, Catalog numbers 405011000 and 405011000US2 Class II 2023-12-05

RECORDED — these are the FDA's published recall enforcement records (openFDA). Recalls are listed under the exact firm name as filed; a large manufacturer may also file under name variants, so this may not be the company's complete cross-variant record — confirm at the FDA recall database. This page informs and routes; it is not medical advice or a verdict on the company.

Machine-readable: JSON-LD · Markdown