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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 81009

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
August 09, 2018
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Besmed Health Business Corporation

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

Ambu Aura40 Standard, Reusable Laryngeal Mask Catalog Number: 340300000

Z-0109-2019
Recall number
Z-0109-2019
Initiated
August 09, 2018
Classification
Class II
Status
Terminated
Quantity
267 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Ambu Aura40 Standard, Reusable Laryngeal Mask packaged in a pouch marked AuraStraight Silicone, Single Use Laryngeal Mask Sterile

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Error in labeling

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Lot Numbers: MO0612G40021 and MO0605G40014

Distribution pattern

US Nationwide, and country of Canada.