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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 94831

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

Open FDA event record

Event summary

Timeline bucket
June 11, 2024
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Ethicon Sarl, a Johnson & Johnson Company

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

SURGICEL FIBRILLAR 1INX2IN(2.5CMX5.1CM), Product Number: 1961

Z-2406-2024
Recall number
Z-2406-2024
Initiated
June 11, 2024
Classification
Class II
Status
Ongoing
Quantity
450,793 units (65,950 US, 384,843 OUS)

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
pouches were found torn open, impacting the sterile

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

Some foil pouches were found torn open, impacting the sterile barrier which was traced to a specific machine used during product packaging.

Code information

Product Number: 1961; UDI/DI: 10705031003118 (primary), 20705031003115 (box of 10); Lot numbers: TFB9151, TEB6531, TFB8781, TEB6861, TEB6511, SKE2201, SKE2101, TDB5981, SLE4411, TEB7821, TGB9291, SBB2291, TEB6411, TEB7071, TBB2481, TBB2491, TCB4081, TCB3751, TCB3781, TEB7211, TEB6871, TEB7601, TEB6521, TCB3351, SJE0361, TCB4071, TCB4481, TCB2931, TFB8381, TGB9801, TBB1511, SJE0241, SDB5001, RPE3591, RPE3181, RME2541, TBB1661, TCB4061, TCB4471, TCB4051, SKE2111, SKE1811, SKE1791, SJB9871, SJE0231, SHB9841, TJE1191, TDB5991, TGB9301, TDB5611, TDB5621, TFB8361, SKE1781, SKE1801, TFB8001, TFB8371, TJE1201, TCB3341, TDB5631, TDB5151, TDB6001;

Distribution pattern

Worldwide distribution - US Nationwide and the countries of India and Japan.

device · product 2 of 2

SURGICEL FIBRILLAR 1INX2IN(2.5CMX5.1CM), Product Number: 1963

Z-2407-2024
Recall number
Z-2407-2024
Initiated
June 11, 2024
Classification
Class II
Status
Ongoing
Quantity
39,010 units (All US)

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
pouches were found torn open, impacting the sterile

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

Some foil pouches were found torn open, impacting the sterile barrier which was traced to a specific machine used during product packaging.

Code information

Product Number: 1963; UDI/DI: 10705031003132 (primary), 20705031003139 (box of 10); Lot numbers:

Distribution pattern

Worldwide distribution - US Nationwide and the countries of India and Japan.