RegWardenFDA facility compliance records
Recall

Class II — Hollister Incorporated

Recalling firmHollister Inc.
Registered facilityView this company's 7 registered facilities → (openFDA recall records do not name a specific facility)
ClassificationClass II
StatusOngoing
ReasonHollister received reports of decreased skin barrier wear time which could can lead to tube migration
ProductAnchorFast Guard, Oral Endotracheal Tube Fastener, REF 9800,
Quantity4,955 box / 59,460 eaches
DistributionWorldwide distribution - US Nationwide and the country of Canada.
Initiated2024-12-23
Classified2025-02-19
Recall numberZ-1181-2025
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class II recall — Hollister Incorporated (Z-1181-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/96181/

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