Ambu Inc.: Medical Device Recall in 2016 - (Recall #: Z-1236-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: February 10, 2016

Date Posted: March 30, 2016

Recall Number: Z-1236-2016

Event ID: 73366

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.

Status: Terminated

Product Quantity: Total Numbers of unit distributed: 45990 pes (USA)

Code Information:

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.

Distribution Pattern:

Please see attached consignee list

Voluntary or Mandated:

Voluntary: Firm initiated