HOLLISTER INCORPORATED
2 recall(s) on record — most severe on record: Class II.
Activity by year
- Recalls (2)
- Inspections (1)
Devices registered here (1)
- Catheter, StraightProduct code EZD (opens in a new tab) · Class II · Gastroenterology, Urology · 21 CFR 876.5130
Recalls & enforcement
- Class IIOngoing2024-12-23Hollister received reports of decreased skin barrier wear time which could can lead to tube migration
- Class IITerminated2021-02-11The 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.
FDA inspections (1)
- NAI2017-12-19No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices
Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.
Related
- All facilities operated by Hollister Inc.
- Hollister Medical India Private Limited (IN)
- Hollister Services BV (NL)
- HOLLISTER INCORPORATED (VA)
- HOLLISTER, INC. (TN)
- Hollister Lietuva UAB (LT)
- HOLLISTER ULC (IE)
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)
Cite this record
RegWarden. “HOLLISTER INCORPORATED (FEI 1480288) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/1480288-hollister-incorporated/
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