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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 96181

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

Open FDA event record

Event summary

Timeline bucket
December 23, 2024
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Hollister Incorporated

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

4 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 4

AnchorFast Guard Select, Oral Endotracheal Tube Fastener, REF 9700,

Z-1178-2025
Recall number
Z-1178-2025
Initiated
December 23, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Hollister Incorporated
Quantity
701 box / 8,412 eaches

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Hollister received reports of decreased skin barrier wear time which could can lead to tube migration

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Hollister received reports of decreased skin barrier wear time which could can lead to tube migration

Code information

UDI/DI 00610075095810, Lot Numbers: 4J162, 4J172, 4J182, 4L172, 4L182

Distribution pattern

Worldwide distribution - US Nationwide and the country of Canada.

device · product 2 of 4

AnchorFast SlimFit, Oral Endotracheal Tube Fastener, REF 9787,

Z-1179-2025
Recall number
Z-1179-2025
Initiated
December 23, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Hollister Incorporated
Quantity
45 box / 540 eaches

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Hollister received reports of decreased skin barrier wear time which could can lead to tube migration

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Hollister received reports of decreased skin barrier wear time which could can lead to tube migration

Code information

UDI/DI 00610075095834, Lot Numbers: 4L172, 4L182

Distribution pattern

Worldwide distribution - US Nationwide and the country of Canada.

device · product 3 of 4

AnchorFast, Oral Endotracheal Tube Fastener, REF 9799,

Z-1180-2025
Recall number
Z-1180-2025
Initiated
December 23, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Hollister Incorporated
Quantity
30,527 box / 366,324 eaches

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Hollister received reports of decreased skin barrier wear time which could can lead to tube migration

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Hollister received reports of decreased skin barrier wear time which could can lead to tube migration

Code information

UDI/DI 00610075129386, Lot Numbers: Lot, 4I192, 4I202, 4I212, 4I222, 4I232, 4I242, 4I252, 4I262, 4I272, 4I282, 4I292, 4I302, 4J012, 4J022, 4J032, 4J042, 4J052, 4J062, 4J072, 4J082, 4J092, 4J102, 4J112, 4J122, 4J132, 4J142, 4J152, 4J162, 4J212, 4J222, 4J232, 4J242, 4J252, 4J262, 4J272, 4J282, 4J292, 4J302, 4J312, 4K012, 4K022, 4K032, 4K042, 4K052, 4K062, 4K072, 4K082, 4K092, 4K102, 4K112, 4K122, 4K132, 4K142, 4K152, 4K162, 4K172, 4K182, 4K192, 4K202, 4K212, 4K222, 4K232, 4K242, 4K252, 4K262, 4K272, 4K282, 4K292, 4K302, 4L012, 4L022, 4L032, 4L042, 4L092, 4L112, 4L122, 4L132, 4L142, 4L152, 4L162, 4L172, 4L182.

Distribution pattern

Worldwide distribution - US Nationwide and the country of Canada.

device · product 4 of 4

AnchorFast Guard, Oral Endotracheal Tube Fastener, REF 9800,

Z-1181-2025
Recall number
Z-1181-2025
Initiated
December 23, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Hollister Incorporated
Quantity
4,955 box / 59,460 eaches

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Hollister received reports of decreased skin barrier wear time which could can lead to tube migration

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Hollister received reports of decreased skin barrier wear time which could can lead to tube migration

Code information

UDI/DI 00610075186518, Lot Numbers: 4K162, 4K172, 4K182, 4K192, 4K202, 4K212, 4K222, 4K232, 4K252, 4K262, 4L012, 4L022, 4L032, 4L042, 4L052, 4L132.

Distribution pattern

Worldwide distribution - US Nationwide and the country of Canada.