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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 94484

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

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Event summary

Timeline bucket
April 15, 2024
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Covidien, LP

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

Tri-Staple 2.0 Black Reinforced Intelligent Reload- Applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection of tissue and creation of anastomosis Model: SIGTRSB60AXT

Z-1891-2024
Recall number
Z-1891-2024
Initiated
April 15, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Covidien, LP
Quantity
1681 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential damage to the cartridge can result in poor staple formation and/or incomplete staple line, may cause a delay in surgery

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential damage to the cartridge can result in poor staple formation and/or incomplete staple line, may cause a delay in surgery

Code information

GTIN: 10884521717633 20884521717630 Lot #: N3G1372Y

Distribution pattern

Worldwide - US Nationwide distribution in the state of NJ and the countries of Australia, Japan, New Zealand, Saudi Arabia, Singapore, South Africa, Taiwan, Thailand.