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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 95480

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

Open FDA event record

Event summary

Timeline bucket
April 29, 2022
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Nihon Kohden America Inc

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

Adult Cap-ONE Biteblock REF YG-227T The cap-ONE Biteblock is intended to sample CO2 and administer supplemental oxygen, for patients who can wear a 20mm bite block, during endoscopy type procedures. The device is intended for single patient use only.

Z-0314-2025
Recall number
Z-0314-2025
Initiated
April 29, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Nihon Kohden America Inc
Quantity
17 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Due to products being shipped/distributed to customers after the products expiration date had past.

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

Due to products being shipped/distributed to customers after the products expiration date had past.

Code information

Model:YG-227T DI: 14931921904043 Lot Numbers: 706121CB, 706301CB, 707211CB

Distribution pattern

U.S. Nationwide distribution in the states of CA, GA, ID, KY, MA, MO, NC, OR, and UT.