Hollister Incorporated recalls AnchorFast Guard Select
Reason for recall
Hollister received reports of decreased skin barrier wear time which could can lead to tube migration
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
Affected products & lots
- AnchorFast Guard Select, Oral Endotracheal Tube Fastener, REF97005 affected lots4J1624J1724J1824L1724L182
What the firm is doing
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 ComplaintCommunication@Hollister.com. 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.
DistributionShow detailsHide
Worldwide distribution - US Nationwide and the country of Canada.
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-1178-2025
- FDA device classification · CBHOfficial FDA classification for this device type
- CFR regulation · 21 CFR 868.5770The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find Hollister IncorporatedSearch for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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