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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 96272

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

Open FDA event record

Event summary

Timeline bucket
February 07, 2025
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Cordis US Corp

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

Vista Brite Tip, Judkins Right 4, REF SM7504, JR3 VBT (Special) 110 cm 6F. Guiding catheter is intended for use for intravascular introduction of interventional/diagnostic devices into the coronary or peripheral vascular systems.

Z-1330-2025
Recall number
Z-1330-2025
Initiated
February 07, 2025
Classification
Class II
Status
Ongoing
Recalling firm
Cordis US Corp
Quantity
12 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Catheter manufactured at the incorrect length.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Catheter manufactured at the incorrect length.

Code information

UDI: 20705032042991/ Lot Number: 18368326

Distribution pattern

US: WA OUS: Japan