CLASS II Device recall · Reported 24 Oct 2018 · FDA Enforcement Report
Ambu Aura40 Standard, Reusable Laryngeal Mask recalled
Besmed Health Business is recalling Ambu Aura40 Standard, Reusable Laryngeal Mask, distributed nationwide in the US. The recall was initiated on 9 Aug 2018 and the FDA has classified it as Class II.
Check your package
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-0109-2019
- FDA event ID
- 81009
- Recalling firm
- Besmed Health Business, New Taipei City, N/A
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 9 Aug 2018
- FDA classified
- 15 Oct 2018
- Reported
- 24 Oct 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Masks, Gloves & PPE
Timeline
| 9 Aug 2018 | Recall initiated by company | |
| 15 Oct 2018 | Classified by FDA | +67 days |
| 24 Oct 2018 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Ambu Aura40 Standard, Reusable Laryngeal Mask packaged in a pouch marked AuraStraight Silicone, Single Use Laryngeal Mask Sterile
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 Aura40 Standard, Reusable Laryngeal Mask Catalog Number: 340300000
Where it was distributed
US Nationwide, and country of Canada.
Questions about this recall
Why was it recalled?
Ambu Aura40 Standard, Reusable Laryngeal Mask packaged in a pouch marked AuraStraight Silicone, Single Use Laryngeal Mask Sterile
Which lots are affected?
Lot Numbers: MO0612G40021 and MO0605G40014
Where was it sold?
US Nationwide, and country of Canada.
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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