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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 98871

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, 2026
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

Covidien EndoStitch" Polysorb Single Use Loading Unit; Product numbers: 170053 and 170071;

Z-2281-2026
Recall number
Z-2281-2026
Initiated
April 15, 2026
Classification
Class II
Status
Ongoing
Recalling firm
Covidien, LP
Quantity
2448 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The presence of holes in the pouch may compromise the package s ability to maintain the sterile barrier and protect the product from environmental exposure.

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 presence of holes in the pouch may compromise the package s ability to maintain the sterile barrier and protect the product from environmental exposure.

Code information

1. Product Number: 170053; UDI-DI: 10884521126732; UPN: 20884521126739; Lot number: J5L2332Y; 2. Product Number: 170071; UDI-DI: 10884521126787; UPN: 20884521126784; Lot number: J5H2924Y;

Distribution pattern

Domestic: Nationwide distribution; International: Austria, Canada, Denmark, France, Italy;