Facility
AMBU INNOVATION GMBH
7 recall(s) on record — most severe on record: Class I.
| FDA Establishment Identifier (FEI) | 3016497307 |
|---|---|
| Establishment type | Develop Specifications But Do Not Manufacture At This Facility |
| Location | Karl-Drais-Str. 4B Augsburg Bavaria, DE 86159 |
| Registration status | Active · expires 2026 |
| Parent company | Ambu A/S (owner-operator 10076603) |
| Brand names | Ambu aScope Duodeno; Ambu aBox Duodeno |
Devices registered here (2)
- Endoscopic Video Imaging System/Component, Gastroenterology-UrologyProduct code FET · Class II · Gastroenterology, Urology · 21 CFR 876.1500
- Duodenoscope And Accessories, Flexible/RigidProduct code FDT · Class II · Gastroenterology, Urology · 21 CFR 876.1500
Recalls & enforcement
- Class IOngoing2025-07-09Potential for the manometer port being blocked rendering the manometer non-functional.
- Class IIOngoing2025-04-07Incorrect labeling in which the front red pouch label did not match the actual size of the medical device. The label on the front of the scope incorrectly states 5.0/2.2 while the back label, shipping box and product inside correctly states 5.6/2.8.
- Class IIOngoing2024-09-16Ambu has received complaints on Ambu¿ VivaSight 2 DLTs regarding hyper angulation of the distal end. The hyper angulation can lead to an increased risk of complications during intubation and potential airway injury.
- Class IIOngoing2023-12-05Instructions for Use have been updated to add the following warning: Use only M4 screws with the length of 14 16 mm when mounting Ambu aView 2 Advance on a VESA interface. Using longer screw lengths will penetrate the lithium-ion battery and result in a fire hazard and battery
- Class IIOngoing2023-07-21Multiple impacts, for example from being dropped, can cause to the Ambu aView 2 Advance to short-circuit and under special circumstances make the lithium-ion battery in the device combust leading to smoke and flames
- Class IIOngoing2022-06-03Firm has received complaints on the device concerning leak/rupture of either the bronchial or tracheal cuff. Leakage during procedure could lead to loss of secure airway and will require re-intubation of patient.
- Class IITerminated2016-02-10Ambu, 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
Related
Source: U.S. FDA via openFDA (device registration & enforcement). Data as of 2026-08-15. Verify this facility record at FDA →
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