Reported Oct 24, 2018 · Terminated

Ambu Aura40 Standard, Reusable Laryngeal Mask Catalog Number: 340300000

Besmed Health Business Corporation

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Besmed Health Business Corporation · No.5, Lane 116, Wu-Kong 2nd Road · New Taipei City, N/A · N/A

Is this the product you have?

  • Ambu Aura40 Standard
  • Reusable Laryngeal Mask Catalog Number340300000
Lot codes and dates
  • Lot NumbersMO0612G40021 and MO0605G40014
Amount recalled
267 units

Where it was sold

  • Nationwide

Why it was recalled

Ambu Aura40 Standard, Reusable Laryngeal Mask packaged in a pouch marked AuraStraight Silicone, Single Use Laryngeal Mask Sterile

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated May 10, 2019 · Data as of Sep 19, 6:15 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.