Food, drugs, devices › Ambu Inc.
Device recall: Ambu, Aura Gain - Single Use Laryngeal Mask- Sterile for use as an alternative to a face mask for achieving and maintain
Ambu Inc. (Columbia, MD) initiated this device recall on 10 Feb 2016; FDA lists 1 product record under event 73366, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 91% of the 1,232 device enforcement events initiated in 2016 carry the same class.
Status: Terminated, terminated 22 Jun 2016. Initiation: voluntary: firm initiated. Ambu Inc. has 7 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Ambu Inc., Columbia, MD.
Reason for recall
"Ambu, Aura Gain laryngeal Mask, was found to have lack of Sterility Assurance. The firm discovered the problem during final quality control at manufacturing site. Damage to the sterile barrier (the pouch) may compromise a medical device's sterility,leading to contamination of the product and,ultimately,patient complications."
Distribution
"Please see attached consignee list"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1236-2016 | Ambu, Aura Gain - Single Use Laryngeal Mask- Sterile for use as an alternative to a face mask for achieving and maintaining control of the airway during routine emergency anesthetic procedures. | Total Numbers of unit distributed: 45990 pes (USA) | Class II | Terminated | 30 Mar 2016 |
Context
Other enforcement events for Ambu Inc.
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 9 Jul 2025 | Ambu SPUR II Labeled as the following: 1 SPUR II Adult Resuscitator, Adult, Catalog Number: 523211000 2 SPUR II Adult Re | Device | Class I | 1 |
| 7 Apr 2025 | Ambu aScope" 5 Broncho HD 5.6/2.8 Sampler Set. Model Number: 622002000US | Device | Class II | 1 |
| 16 Sep 2024 | Ambu¿ VivaSight 2 DLT Endobronchial tube, 35 FR (Catalog Number 412351000), 37 Fr (Catalog Number 412371000), 39 Fr (Cat | Device | Class II | 1 |
| 5 Dec 2023 | Ambu aView 2 A Monitor, Catalog numbers 405011000 and 405011000US2 | Device | Class II | 1 |
| 21 Jul 2023 | Ambu aView 2 A Monitor-The Ambu aView 2 Advance is intended to display live imaging data from compatible Ambu visualizat | Device | Class II | 1 |
| 3 Jun 2022 | Ambu VivaSight 2 DLT; endobronchial tube system used for verifying tube placement and repositioning. Catalog numbers 412 | Device | Class II | 1 |
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Ambu, Aura Gain laryngeal Mask, was found to have lack of Sterility Assurance. The firm discovered the problem during final quality control at manufacturing site. Damage to the sterile barrier (the pouch) may compromise a medical device's sterility,leading to contamination of the product and,ultimately,patient complications."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Please see attached consignee list"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 22 Jun 2016. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.