FDAClass IIFebruary 26, 2025

AnchorFast Guard recall

AnchorFast Guard, Oral Endotracheal Tube Fastener, REF 9800,

Why was AnchorFast Guard recalled?

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

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
AnchorFast Guard, Oral Endotracheal Tube Fastener, REF 9800,
Recalling firm
Hollister Incorporated
Quantity
4,955 box / 59,460 eaches
Distribution
Worldwide distribution - US Nationwide and the country of Canada.
Recall date
February 26, 2025
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls