Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 82909

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
April 19, 2019
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Ethicon, 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

2 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 2

ETHIBOND EXCEL¿ Polyester Suture-ETHIBOND Green 75cm USP1 Single Armed CT-1 Product Code: X425H Product Usage: ETHIBOND EXCEL Suture is intended for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures

Z-1841-2019
Recall number
Z-1841-2019
Initiated
April 19, 2019
Classification
Class II
Status
Terminated
Recalling firm
Ethicon, Inc.
Quantity
1296 eaches

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Possibility that a suture raw material containing high endotoxin levels was used in the manufacturing of this lot

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Material/Component Contamination

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Possibility that a suture raw material containing high endotoxin levels was used in the manufacturing of this lot

Code information

Lot Code: PBQ426

Distribution pattern

Worldwide - US Nationwide Distribution - IA, NJ, RI, TX, WV Foreign: Canada

device · product 2 of 2

ETHIBOND EXCEL ETHIBOND Polvester Suture-Green 75cm USP1 Single Armed CTX Product Code: X865W Product Usage: ETHIBOND EXCEL Suture is intended for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures

Z-1842-2019
Recall number
Z-1842-2019
Initiated
April 19, 2019
Classification
Class II
Status
Terminated
Recalling firm
Ethicon, Inc.
Quantity
36 eaches

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Possibility that a suture raw material containing high endotoxin levels was used in the manufacturing of this lot

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Material/Component Contamination

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Possibility that a suture raw material containing high endotoxin levels was used in the manufacturing of this lot

Code information

Lot Code:PBQ797

Distribution pattern

Worldwide - US Nationwide Distribution - IA, NJ, RI, TX, WV Foreign: Canada