HOLLISTER ULC
2 recall(s) on record — most severe on record: Class II.
Activity by year
- Recalls (2)
Devices registered here (1)
- Catheter, UrethralProduct code GBM (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.
Related
- All facilities operated by Hollister Inc.
- Hollister Medical India Private Limited (IN)
- HOLLISTER INCORPORATED (IL)
- Hollister Services BV (NL)
- HOLLISTER INCORPORATED (VA)
- HOLLISTER, INC. (TN)
- Hollister Lietuva UAB (LT)
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 ULC (FEI 3005028195) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3005028195-hollister-ulc/
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