Z-1178-2025Class II

AnchorFast Guard Select, Oral Endotracheal Tube Fastener, REF 9700

Name: Z-1178-2025 AnchorFast Guard Select, Oral Endotracheal Tube Fastener, REF 9700
Creator: Hollister Incorporated
Published: 2024-12-23
License: https://open.fda.gov/license/

Hollister Incorporated / initiated 2024-12-23 / Open, Classified

FDA source

Hollister Incorporated began a recall of AnchorFast Guard Select, Oral Endotracheal Tube Fastener, REF 9700 on 2024-12-23. FDA classified it as Class II and gives the reason as "Hollister received reports of decreased skin barrier wear time which could can lead to tube migration". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1178-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-12-23
Posted: 2025-02-19
Recalling firm: Hollister Incorporated
Product: AnchorFast Guard Select, Oral Endotracheal Tube Fastener, REF 9700,
Product code: CBH Device, Fixation, Tracheal Tube
Reason for recall: Hollister received reports of decreased skin barrier wear time which could can lead to tube migration
FDA root cause: Process change control
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.
Quantity in commerce: 701 box / 8,412 eaches
Distribution: Worldwide distribution - US Nationwide and the country of Canada.
Product codes and lots: UDI/DI 00610075095810, Lot Numbers: 4J162, 4J172, 4J182, 4L172, 4L182

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1178-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1178-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-02-26	2025-02-19
Z-1179-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-02-26	2025-02-19
Z-1180-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-02-26	2025-02-19
Z-1181-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-02-26	2025-02-19

Product code CBH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)