Z-1236-2016Class II

Ambu, Aura Gain - Single Use Laryngeal Mask- Sterile for use as an alternative to a face mask for achieving...

Name: Z-1236-2016 Ambu, Aura Gain - Single Use Laryngeal Mask- Sterile for use as an alternative to a face mask for achieving...
Creator: Ambu Inc.
Published: 2016-02-10
License: https://open.fda.gov/license/

Ambu Inc. / initiated 2016-02-10 / Terminated / root cause: manufacturing process

FDA source

Ambu Inc. began a recall of 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... on 2016-02-10. FDA classified it as Class II and gives the reason 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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1236-2016
Classification: Class II
Status: Terminated
Initiated: 2016-02-10
Posted: 2016-03-24
Terminated: 2016-06-22
Recalling firm: Ambu Inc.
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.
Product code: BTO Tube, Tracheostomy (W/Wo Connector)
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Filed Safety Notice was sent via USPS Certified Mail to all customers on Dec 10,2015.
Quantity in commerce: Total Numbers of unit distributed: 45990 pes (USA)
Distribution: Please see attached consignee list
Product codes and lots: Catalog Number:408300000 Size #3:All lots from 1632796 through lot number 1808911except lot number 1779966,1782239, 1795914 Catalog Number: 408400000 Size #4 All lots from 1632799 through lot number 1790075. Catalog Number:408500000 Size #5 All lots from 1632802 through lot number 1810863.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1236-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1236-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-30	2016-03-24

Product code BTO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)