Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 88349

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, 2021
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Ethicon Endo-Surgery 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

ECHELON FLEX Powered Plus Stapler-intended for transection, resection, and/or creation of anastomoses. The instruments have application in multiple open or minimally invasive general, gynecologic, urologic, thoracic, and pediatric surgical procedures. Product Code: PSEE60A

Z-2326-2021
Recall number
Z-2326-2021
Initiated
June 03, 2021
Classification
Class II
Status
Terminated
Recalling firm
Ethicon Endo-Surgery Inc
Quantity
763 eaches

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
Mislabeled

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Mislabeled: Labeled on the package as 60mm contains 45mm devices

Code information

Lot U94V47 Exp Date: July 31, 2023 GTIN: 10705036014607

Distribution pattern

Worldwide distribution - US Nationwide distribution in the states of MD, WA and the countries of Belgium, China, Denmark, Estonia, France, Germany, Italy, Japan, Korea, Latvia, Lithuania, Netherlands, Poland, Portugal, Russia, Spain, Sweden, Switzerland, United Kingdom.