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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 75127

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

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Event summary

Timeline bucket
August 25, 2016
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Merit Medical Systems, 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

Merit Inflation Syringe Kit. Catalog Number KOS-02857

Z-0002-2017
Recall number
Z-0002-2017
Initiated
August 25, 2016
Classification
Class II
Status
Terminated
Quantity
1,297 total units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Merit Medical Systems, Inc. announces a voluntary field action for Merit Inflation Syring Kit due to unit labels missing required device labeling information.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Merit Medical Systems, Inc. announces a voluntary field action for Merit Inflation Syring Kit due to unit labels missing required device labeling information.

Code information

Lot Numbers: H959038, H970334, H984351.

Distribution pattern

One consignee located in CA. No Canadian, other foreign or VA/govt/military consignees.