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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 74901

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

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Event summary

Timeline bucket
August 01, 2016
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

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

ETHICON MERSILENE" Tape (also referred to as MERSILENETM Polyester Fiber Strip or MERSILENETM Fiber Ligature)

Z-2889-2016
Recall number
Z-2889-2016
Initiated
August 01, 2016
Classification
Class II
Status
Terminated
Recalling firm
Ethicon, Inc.
Quantity
396,024 eaches

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
ETHICON MERSILENE" Tape (also referred to as MERSILENETM Polyester Fiber Strip or MERSILENETM Fiber Ligature) products are being recalled since a group of MERSILENE" Tape product codes are being supplied with an incorrect Instructions for Use (IFU) insert.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

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Inspect official wording and provenance

Reason for recall

ETHICON MERSILENE" Tape (also referred to as MERSILENETM Polyester Fiber Strip or MERSILENETM Fiber Ligature) products are being recalled since a group of MERSILENE" Tape product codes are being supplied with an incorrect Instructions for Use (IFU) insert.

Code information

All unexpired lots MERSILENE" RS20 MERSILENE" RS21 MERSILENE" RS22 MERSILENE" RS23 MERSILENE" D10076 MERSILENE" D10117 MERSILENE" D5789 MERSILENE" D7164 MERSILENE" D8014 MERSILENE" D8062 MERSILENE" D8113 MERSILENE" D9212

Distribution pattern

Worldwide Distribution - USA (nationwide) Distribution including Puerto Rico.