AnchorFast Guard Select endotracheal tube fasteners recalled due to decreased skin barrier wear
Hollister is recalling AnchorFast Guard Select endotracheal tube fasteners due to decreased skin barrier wear time that could lead to tube migration.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: AnchorFast Guard Select fasteners are critical airway-management devices; failure could lead to tube migration and compromised breathing. The source reports no injuries or deaths but describes a theoretical risk. This meets the rubric criterion for Score 3: risk-of-harm product with no reported injury.
Plain-English summary
Hollister Incorporated is recalling AnchorFast Guard Select, Oral Endotracheal Tube Fasteners (REF 9700) due to reports of decreased skin barrier wear time. These fasteners are used to secure endotracheal breathing tubes in intubated patients. The decreased wear of the skin barrier could lead to tube migration, where the breathing tube moves from its proper position.
The recall affects approximately 8,412 individual units distributed worldwide, including the United States and Canada. Affected lot numbers are 4J162, 4J172, 4J182, 4L172, and 4L182.
Healthcare providers and patients using affected devices should contact Hollister Incorporated or the FDA MedWatch program with any concerns or to report any adverse events.
The recalled product
- Product
- AnchorFast Guard Select, Oral Endotracheal Tube Fastener, REF 9700,
- Manufacturer
- Hollister Incorporated
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 (6)
- UDI/DI 00610075095810
- Lot Numbers: 4J162
- 4J172
- 4J182
- 4L172
- 4L182
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 →- HighAnchorFast Guard Endotracheal Tube Fasteners Recalled Due to Tube Migration Risk
FDA (Devices) · 2025-02-26
- HighEndotracheal Tube Fastener Recalled for Potential Tube Migration Risk
FDA (Devices) · 2025-02-26
- HighEndotracheal Tube Fastener Recalled for Decreased Skin Barrier Wear
FDA (Devices) · 2025-02-26
- HighHollister Recalls Vertical Drain Tube Attachment Devices Due to Separation Risk
FDA (Devices) · 2021-04-07
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