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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 93725

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

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Event summary

Timeline bucket
December 18, 2023
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Vortex Surgical 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

Vortex Surgical ACTU8 FORCEPS, 25 GA, ADAPTIVE, REF VS0740.25

Z-0970-2024
Recall number
Z-0970-2024
Initiated
December 18, 2023
Classification
Class II
Status
Terminated
Recalling firm
Vortex Surgical Inc.
Quantity
800 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Reason for the voluntary recall is residue was identified on the two forceps tips of a customer in Korea. The residue is associated with one lot of forceps tips which were utilized in two lots of ACTU8 Adaptive Forceps Tips occurring in 0.25% of those lots.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Reason for the voluntary recall is residue was identified on the two forceps tips of a customer in Korea. The residue is associated with one lot of forceps tips which were utilized in two lots of ACTU8 Adaptive Forceps Tips occurring in 0.25% of those lots.

Code information

UDI/DI 00810123481132, Lot Numbers 2212002 and 2212020

Distribution pattern

Worldwide - US Nationwide distribution in the states of OH, WA, MN, MI, IA and the country of Republic of Korea