RegWardenFDA facility compliance records
Facility

HOLLISTER INCORPORATED

2 recall(s) on record — most severe on record: Class II.

Activity by year

FDA actions on record by year2017: 1 inspections; 2021: 1 recalls; 2024: 1 recalls1201720182019202012021202220231202420252026
  • Recalls (2)
  • Inspections (1)

Devices registered here (1)

Recalls & enforcement

  • Class IIOngoing2024-12-23
    Hollister received reports of decreased skin barrier wear time which could can lead to tube migration
  • Class IITerminated2021-02-11
    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.

FDA inspections (1)

  • NAI2017-12-19
    No 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

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/

Not open yet

Alerts for HOLLISTER INCORPORATED

Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.

Planned

Want a one-page facility brief?

A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.