Ambu Inc. — FDA Profile

Summary

Total Recalls: 7 (1 Class I)
510(k) Clearances: 70
Inspections: 4
Compliance Actions: 0

Recent Recalls

Number	Class	Product	Date
Z-2181-2025	Class I	Ambu SPUR II Labeled as the following: 1 SPUR II Adult Resuscitator, Adult, Catalog Number: 52321100	July 9, 2025
Z-1723-2025	Class II	Ambu aScope" 5 Broncho HD 5.6/2.8 Sampler Set. Model Number: 622002000US	April 7, 2025
Z-0261-2025	Class II	Ambu¿ VivaSight 2 DLT Endobronchial tube, 35 FR (Catalog Number 412351000), 37 Fr (Catalog Number 41	September 16, 2024
Z-0714-2024	Class II	Ambu aView 2 A Monitor, Catalog numbers 405011000 and 405011000US2	December 5, 2023
Z-2628-2023	Class II	Ambu aView 2 A Monitor-The Ambu aView 2 Advance is intended to display live imaging data from compat	July 21, 2023
Z-1420-2022	Class II	Ambu VivaSight 2 DLT; endobronchial tube system used for verifying tube placement and repositioning.	June 3, 2022
Z-1236-2016	Class II	Ambu, Aura Gain - Single Use Laryngeal Mask- Sterile for use as an alternative to a face mask for	February 10, 2016

Recent 510(k) Clearances

K-Number	Device	Date
K250269	Ambu® aScope 5 Cysto HD (Standard Deflection); Ambu® aScope 5 Cysto HD (Reverse Deflection)	June 11, 2025
K240849	Ambu® aScope 5 Cysto HD (Standard Deflection); Ambu® aScope 5 Cysto HD (Reverse Deflection); Ambu®	October 16, 2024
K240848	Ambu® aScope 5 Cysto HD (Standard Deflection); Ambu® aScope 5 Cysto HD (Reverse Deflection); Ambu®	October 10, 2024
K242108	Ambu® aScope 5 Uretero (Standard Deflection); Ambu® aScope 5 Uretero (Reverse Deflection); Ambu® a	August 16, 2024
K233630	Ambu® aScope 5 Uretero (Standard Deflection); Ambu® aScope 5 Uretero (Reverse Deflection); Ambu® a	June 24, 2024
K233886	Ambu® aScope Duodeno 2, Ambu® aBox 2	April 16, 2024
K232919	Ambu® aScope Gastro Large; Ambu® aBox 2	April 5, 2024
K233671	Ambu® aScope 5 Broncho 4.2/2.2; Ambu® aScope 5 Broncho 2.7/1.2; Ambu® aView 2 Advance	January 4, 2024
K232582	Ambu® aScope 5 Broncho 4.2/2.2 Sampler Set	September 20, 2023
K230332	Ambu® aScope Colon; Ambu® aBox 2	September 15, 2023
K230428	Ambu® aScope 5 Broncho 2.7/1.2, Ambu® aScope 5 Broncho 4.2/2.2, Ambu® aBox 2	August 10, 2023
K223299	Ambu® aScope 5 Broncho HD 5.0/2.2, Ambu® aScope 5 Broncho HD 5.6/2.8, Ambu® aView 2 Advance	June 1, 2023
K223782	Ambu aScope 5 Broncho HD 5.6/2.8 Sampler Set, Ambu aScope 5 Broncho HD 5.0/2.2 Sampler Set	January 12, 2023
K220606	Ambu aScope 5 Broncho HD 5.6/2.8, Ambu aScope 5 Broncho HD 5.0/2.2, Ambu aBox 2	July 25, 2022
K212382	Ambu® aScope Gastro, Ambu® aBox2	February 3, 2022
K210883	aScope 4 Broncho Regular Sampler Set 5.0/2.2, aScope 4 Broncho Large Sampler Set 5.8/2.8	June 17, 2021
K203749	Ambu VivaSight 2 DLT, Ambu VivaSight 2 Adapter Cable	May 3, 2021
K193095	Ambu aScope 4 Cysto	April 2, 2020
K190972	Ambu aScope 4 RhinoLaryngo Intervention	July 12, 2019
K191080	Ambu aScope 4 RhinoLaryngo Slim	May 22, 2019