FDA Medical Device Recalls (openFDA)
Besmed Health Business Corporation: Ambu Aura40 Standard, Reusable Laryngeal Mask Catalog Number: 340300000
- Recall number
- Z-0109-2019
- Recalling firm
- Besmed Health Business Corporation
- Product
- Ambu Aura40 Standard, Reusable Laryngeal Mask Catalog Number: 340300000
- Status
- Terminated
- Initiated
- 2018-08-09
- Posted
- not on file
- Terminated
- 2019-05-10
- Reason
- Ambu Aura40 Standard, Reusable Laryngeal Mask packaged in a pouch marked AuraStraight Silicone, Single Use Laryngeal Mask Sterile
- 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 mlo@ambu.com to arrange Return Authorization and replacement.
- Quantity
- 267 units
- Distribution
- US Nationwide, and country of Canada.
- Lot, serial or model codes
- Lot Numbers: MO0612G40021 and MO0605G40014
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- CAE
- Firm FEI
- 3003256355
- Firm city
- New Taipei City
- Firm state
- not on file
- Firm country
- Taiwan
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28