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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 80242

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

Open FDA event record

Event summary

Timeline bucket
April 09, 2018
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Terumo Medical 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

Angio-Seal Evolution Vascular Closure Device, Cat. No. C610135

Z-2337-2018
Recall number
Z-2337-2018
Initiated
April 09, 2018
Classification
Class II
Status
Terminated
Recalling firm
Terumo Medical Corp
Quantity
240

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Two lots of product were released for distribution prior to the completion of all required validation and lot acceptance activities. Although sterile, products from these lots may not function as intended and therefore should not be used.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Release of Material/Component prior to receiving test results

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Two lots of product were released for distribution prior to the completion of all required validation and lot acceptance activities. Although sterile, products from these lots may not function as intended and therefore should not be used.

Code information

5980075, 5980077

Distribution pattern

Distributed to accounts in AL, CA, FL, IA, IN, MI, MO, NC, NY, SD, TN, and TX.