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Ambu Inc. FDA Recalls
6 recalls on file across devices, 1 of them Class I and 6 still open. This firm is not matched to a listed company.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| Ambu SPUR II Labeled as the following: 1 SPUR II Adult Resuscitator, Adult, Catalog Number: 523211000 2 SPUR II Adult ReClass IJul 9, 2025Potential for the manometer port being blocked rendering the |
| Ambu aScope" 5 Broncho HD 5.6/2.8 Sampler Set. Model Number: 622002000USClass IIApr 7, 2025Incorrect labeling in which the front red pouch label did no |
| Ambu¿ VivaSight 2 DLT Endobronchial tube, 35 FR (Catalog Number 412351000), 37 Fr (Catalog Number 412371000), 39 Fr (CatClass IISep 16, 2024Ambu has received complaints on Ambu¿ VivaSight 2 DLTs regar |
| Ambu aView 2 A Monitor, Catalog numbers 405011000 and 405011000US2Class IIDec 5, 2023Instructions for Use have been updated to add the following |
| Ambu aView 2 A Monitor-The Ambu aView 2 Advance is intended to display live imaging data from compatible Ambu visualizatClass IIJul 21, 2023Multiple impacts, for example from being dropped, can cause |
| Ambu VivaSight 2 DLT; endobronchial tube system used for verifying tube placement and repositioning. Catalog numbers 412Class IIJun 3, 2022Firm has received complaints on the device concerning leak/r |