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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 82519

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

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Event summary

Timeline bucket
April 01, 2019
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Olympus Corporation of the Americas

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

Olympus MAJ-209 Single Use Suction Valves, Model Number MAJ-209 Product Usage: This product has been designed to be attached to the suction cylinder of compatible endoscopes for aspirating fluid from the distal end of the endoscopes through the instrument channel. Compatible endoscopes include Olympus bronchoscopes, cystoscopes, rhino-laryngoscopes and pleurascopes models.

Z-2148-2019
Recall number
Z-2148-2019
Initiated
April 01, 2019
Classification
Class II
Status
Terminated
Quantity
310000

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for the single use suction valve to come apart and/or remain stuck inside the endoscope.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for the single use suction valve to come apart and/or remain stuck inside the endoscope.

Code information

Lot numbers: 88H, 89H, 8XH, 8YH, 8ZH, 91H

Distribution pattern

The products were distributed US Nationwide.