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Open, Classified

AnchorFast, Oral Endotracheal Tube Fastener, REF 9799,

FDA Recall Z-1180-2025 · Posted 2025-02-19

Recalling FirmHollister Incorporated
Recall StatusOpen, Classified
Product CodeCBH
Date Initiated2024-12-23
Product Quantity30,527 box / 366,324 eaches

Reason for Recall

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

Firm Action

Hollister issued an URGENT - MEDICAL DEVICE RECALL notice to its consignees on 12/23/2024 via FedEx and email. The notice explained the reason for the recall and potential risk and instructed customers to quarantine affected inventory, discard the product per their local procedures for product destruction, and Please complete and return the response form attached as soon as possible, even if you do not have affected product in your possession and send to [email protected]. For product credit requests: If you are a direct customer of Hollister, contact Hollister Incorporated Customer Service for product credit at: 1-800-323-4060 (prompt #1). If you purchase product from a distributor, please contact your distributor for product credit. Hollister has posted this recall on their website with the link to the page.

Root Cause

Process change control

Distribution Pattern

Worldwide distribution - US Nationwide and the country of Canada.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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