Hollister Inc.
2 recall(s) on record — most severe on record: Class II.
Recalls by year
- Recalls (2)
Registered facilities (7)
- Hollister Medical India Private Limited FEI 3008191244 · IN
- HOLLISTER INCORPORATED FEI 1480288 · IL
- Hollister Services BV FEI 3014404707 · NL
- HOLLISTER INCORPORATED FEI 1119193 · VA
- HOLLISTER, INC. FEI 3003172243 · TN
- Hollister Lietuva UAB FEI 3016675012 · LT
- HOLLISTER ULC FEI 3005028195 · IE
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.
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.
Cite this record
RegWarden. “Hollister Inc. — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-1480288-hollister-inc/
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