Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Ambu Recalled by Ambu Inc. Due to Ambu, Aura Gain laryngeal Mask, was found to...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Ambu Inc. directly.
Affected Products
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.
Quantity: Total Numbers of unit distributed: 45990 pes (USA)
Why Was This Recalled?
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.
Where Was This Sold?
Please see attached consignee list
About Ambu Inc.
Ambu Inc. has 7 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report