Ambu Aura Gain Laryngeal Masks Recalled for Sterility Assurance Failure
Ambu Inc. is recalling Aura Gain laryngeal masks because damage to the sterile barrier may compromise sterility, risking patient contamination.
The agency’s classification
FDA (Devices): Class II
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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (sterile medical device) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Ambu Inc. is recalling Ambu Aura Gain Single Use Laryngeal Masks (Sterile) due to a lack of Sterility Assurance. The firm identified the issue during final quality control at the manufacturing site. The recall affects 45,990 units distributed in the USA.
The recall is necessary because damage to the sterile barrier (the pouch) may compromise the medical device's sterility. This compromise could lead to contamination of the product and, ultimately, patient complications. The affected products are used as an alternative to a face mask for achieving and maintaining control of the airway during routine emergency anesthetic procedures.
The recall covers specific catalog numbers and lot ranges: Catalog Number 408300000 (Size #3) for lots 1632796 through 1808911 (excluding 1779966, 1782239, and 1795914); Catalog Number 408400000 (Size #4) for lots 1632799 through 1790075; and Catalog Number 408500000 (Size #5) for lots 1632802 through 1810863. Consumers and healthcare providers should check their inventory against these lot numbers and stop using the affected devices.
The recalled product
- Product
- 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.
- Manufacturer
- Ambu Inc.
- Affected units
- 45,990
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- 1782239
Distribution
Distribution scope not specified by the agency.
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