The Recall Desk
HighFDA (Devices)·Z-1181-2025·Announced 2025-02-26

AnchorFast Guard Endotracheal Tube Fasteners Recalled Due to Tube Migration Risk

Hollister is recalling AnchorFast Guard endotracheal tube fasteners because decreased skin barrier wear time could cause tube migration. The recall affects multiple lot numbers distributed in the US and Canada.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall with theoretical risk of tube migration that could compromise airway management. No illnesses or injuries have been reported.

Plain-English summary

Hollister Incorporated has recalled AnchorFast Guard Oral Endotracheal Tube Fastener, model REF 9800, due to a potential safety issue. The recall involves 4,955 boxes (59,460 individual units) identified by UDI/DI 00610075186518.

The fastener is designed to secure endotracheal tubes. Hollister received reports of decreased skin barrier wear time, which could lead to tube migration from its intended position.

The affected products were distributed worldwide, including nationwide in the United States and in Canada. Healthcare facilities, hospitals, and medical professionals using these devices should stop use of affected lots immediately.

If you have received any of the recalled products, contact Hollister directly for guidance on returns or replacement. Report any adverse events associated with this device to the FDA MedWatch program.

The recalled product

Product
AnchorFast Guard, Oral Endotracheal Tube Fastener, REF 9800,
Manufacturer
Hollister Incorporated
Category
Medical Device — Airway Management
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (17)

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

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 4 recalled by Hollister Incorporated under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

Related recalls

Same manufacturer · Hollister Incorporated

See all →