Libertyville, IL, United States
Hollister Incorporated recalls
2 recalls recorded since 2018, most recently on 23 December 2024. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)1
Terminated or completed1
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 23 December 2024
- Reason
- Hollister received reports of decreased skin barrier wear time which could can lead to tube migration
- Distribution
- Worldwide distribution - US Nationwide and the country of Canada.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1179-2025, Z-1180-2025, Z-1178-2025, Z-1181-2025
- AnchorFast SlimFit, Oral Endotracheal Tube Fastener, REF 9787,
- AnchorFast, Oral Endotracheal Tube Fastener, REF 9799,
- AnchorFast Guard Select, Oral Endotracheal Tube Fastener, REF 9700,
- AnchorFast Guard, Oral Endotracheal Tube Fastener, REF 9800,
Terminated Class II Medical devices
- Recall started
- 11 February 2021
- Terminated
- 14 September 2022
- Reason
- The tube holder can separate from the barrier that secures the device to the patients' body. The tube holder has the potential failure to separate from the barrier. This separation might contribute to the potential risk of the tube/drain/catheter migration or loss.
- Distribution
- Worldwide distribution - US Nationwide distribution including in the states of IL, CO, NJ, CA, AZ, TX, KS, NY, IN, SC, RI, ID, WV, OH, MT, MO, SD, MI, MA, PA, VA, FL, NE, OR, KY, GA, WA, OK, TN, NC, MD, MN, MS, LA , NM, ND and the country of Canada.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1311-2021
- Vertical Drain Tube Attachment Device (VTAD) (Gastrointestinal tube and accessories) - Product Usage: designed to stabilize and secure a variety of catheters, surgical drains, and tubes from sizes 5-40 French.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.