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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 94778

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

Open FDA event record

Event summary

Timeline bucket
June 03, 2024
Product types
Device
Classifications
Class II
Statuses
Completed
Recalling firm wording
ASPEN SURGICAL

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

Endoscopic Kittner Blunt Dissecting Instrument, Intended to be used for blunt dissection of tissue, Model Number KT-9101

Z-2221-2024
Recall number
Z-2221-2024
Initiated
June 03, 2024
Classification
Class II
Status
Completed
Recalling firm
ASPEN SURGICAL
Quantity
1900 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterile barrier may be compromised

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The affected products may have been packaged with a defect in the sterile barrier seal. As a result, the integrity of the sterile barrier may be compromised.

Code information

UDI-DI: 00840113214006; Lot Numbers: 389571, 389576, 390981, 390982

Distribution pattern

US Nationwide