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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 76921

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

Open FDA event record

Event summary

Timeline bucket
March 31, 2017
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

Endopath ETS-FLEX Endoscopic Articulating Linear Cutter, VASCULAR/THIN 35MM

Z-2174-2017
Recall number
Z-2174-2017
Initiated
March 31, 2017
Classification
Class II
Status
Terminated
Recalling firm
Ethicon Endo-Surgery Inc
Quantity
792 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a risk that the pinion gear in the device could fail under extreme use cases.

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

There is a risk that the pinion gear in the device could fail under extreme use cases.

Code information

N91U0W, N91U0X, N91L2P, N91N1J, and N91N2G

Distribution pattern

Worldwide distribution. The previously recalled products were distributed to the following countries: China, Japan, Singapore, and South Korea.