Z-0109-2019Class II

Ambu Aura40 Standard, Reusable Laryngeal Mask Catalog Number: 340300000

Name: Z-0109-2019 Ambu Aura40 Standard, Reusable Laryngeal Mask Catalog Number: 340300000
Creator: Besmed Health Business Corporation
Published: 2018-08-09
License: https://open.fda.gov/license/

Besmed Health Business Corporation / initiated 2018-08-09 / Terminated / root cause: labeling and UDI

FDA source

Besmed Health Business Corporation began a recall of Ambu Aura40 Standard, Reusable Laryngeal Mask Catalog Number: 340300000 on 2018-08-09. FDA classified it as Class II and gives the reason as "Ambu Aura40 Standard, Reusable Laryngeal Mask packaged in a pouch marked AuraStraight Silicone, Single Use Laryngeal Mask Sterile". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0109-2019
Classification: Class II
Status: Terminated
Initiated: 2018-08-09
Posted: 2018-10-15
Terminated: 2019-05-10
Recalling firm: Besmed Health Business Corporation
Product: Ambu Aura40 Standard, Reusable Laryngeal Mask Catalog Number: 340300000
Product code: CAE Airway, Oropharyngeal, Anesthesiology
Reason for recall: Ambu Aura40 Standard, Reusable Laryngeal Mask packaged in a pouch marked AuraStraight Silicone, Single Use Laryngeal Mask Sterile
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: Ambu issued via USPS Certified Mail/Email to customers on Aug 09, 2018 advising users of the problem. If you have affected lot in stock and you are using it as Reusable Laryngeal Mask (following accompanying instruction for use), you can continue to use it and no need to return it. Accounts requested to see if you have affected lots in stock. If you do have it, check Aura40 Standard devices for incorrect labelled pouch, and place wrongly labelled products in quarantine. For collection and replacement by Ambu..Furthermore, please instruct all customers of the received LOT(s), to check their devices for the wrong labelling as well Contact 800 262 8462 x 1121 or email [email protected] to arrange Return Authorization and replacement.
Quantity in commerce: 267 units
Distribution: US Nationwide, and country of Canada.
Product codes and lots: Lot Numbers: MO0612G40021 and MO0605G40014

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0109-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0109-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-24	2018-10-15

Product code CAE

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)