FDA Medical devices recall ·
AnchorFast Guard, Oral Endotracheal Tube Fastener recall
- Recall number
- Z-1181-2025
- Date
- (initiated December 23, 2024)
- Company / brand
- Hollister Incorporated
2000 Hollister Dr, Libertyville, IL, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 4,955 box / 59,460 eaches
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
AnchorFast Guard, Oral Endotracheal Tube Fastener, REF 9800,
Why was it recalled?
Hollister received reports of decreased skin barrier wear time which could can lead to tube migration
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI/DI 00610075186518, Lot Numbers: 4K162, 4K172, 4K182, 4K192, 4K202, 4K212, 4K222, 4K232, 4K252, 4K262, 4L012, 4L022, 4L032, 4L042, 4L052, 4L132.
Distribution
Worldwide distribution - US Nationwide and the country of Canada.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1181-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.