Ambu Inc.
FDA Regulatory Profile
Ambu Inc. appears in FDA public data with 7 recalls — including 1 Class I (most serious) —, 72 510(k) clearances, 4 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2181-2025, Class I) was initiated on July 9, 2025. Its most recent 510(k) clearance was granted on July 14, 2026.
Summary
- Total Recalls
- 7 (1 Class I)
- 510(k) Clearances
- 72
- 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 |
|---|
| K260578 | Ambu® NeurolineTM Cup MRI/CT (Models 72704/21US, 72704/23US, 72704/25US, 72704/27US) Ambu® Neurolin | July 14, 2026 |
| K251583 | Ambu® Virobac II® Exhalation Filter | April 30, 2026 |
| 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 |