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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 96292

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

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Event summary

Timeline bucket
January 27, 2025
Product types
Device
Classifications
Class II
Statuses
Ongoing
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

Prelude IDEAL 4 F Hydrophilic Sheath Introducer, REF: PID4F16021PW/D

Z-1434-2025
Recall number
Z-1434-2025
Initiated
January 27, 2025
Classification
Class II
Status
Ongoing
Quantity
40

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Hydrophilic Sheath Introducer labeled for 4F dilators may instead incorrectly contain 5F dilators. Incorrect dilator use may result in procedure delay.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Hydrophilic Sheath Introducer labeled for 4F dilators may instead incorrectly contain 5F dilators. Incorrect dilator use may result in procedure delay.

Code information

UDI-DI: 00884450693919. Lot: H3082668. Expiration: 14-Nov-24

Distribution pattern

International distribution to the country of Japan.