CLASS II Device recall · Reported 30 Mar 2016 · FDA Enforcement Report

Aura Gain - Single Use Laryngeal Mask- Sterile recalled by Ambu

Ambu is recalling Aura Gain - Single Use Laryngeal Mask- Sterile for use as an alternative to a face mask. The recall was initiated on 10 Feb 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesCatalog 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.

Quantity recalledTotal Numbers of unit distributed: 45990 pes (USA)

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1236-2016
FDA event ID: 73366
Recalling firm: Ambu, Columbia, MD
Classification: Class II
Status: Terminated
Recall initiated: 10 Feb 2016
FDA classified: 24 Mar 2016
Reported: 30 Mar 2016
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Sterility
Device type: Masks, Gloves & PPE

Timeline

10 Feb 2016	Recall initiated by company
24 Mar 2016	Classified by FDA	+43 days
30 Mar 2016	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

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.

Where it was distributed

Please see attached consignee list

Questions about this recall

Why was it recalled?

Which lots are affected?

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.

Where was it sold?

Please see attached consignee list

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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