Hollister Incorporated
366 Draft Ave, STUARTS DRAFT, VA, US
Registered product codes
12 product codes
Recent MDR events
744 on file
- OnliJul 28, 2026Injury9616668-2026-00005
- VaPro PocketJul 27, 2026Injury9616668-2026-00006
- NEW IMAGEJul 10, 2026Injury1119193-2026-00049
- ANCHORFASTJul 2, 2026Injury1119193-2026-00047
- ANCHORFASTJul 2, 2026Injury1119193-2026-00048
- ANCHORFASTJun 30, 2026InjuryMW5190071
- ANCHORFAST ORAL ENDOTRACHEAL TUBE FASTENERJun 23, 2026Injury1119193-2026-00044
- ANCHORFAST ORAL ENDOTRACHEAL TUBE FASTENERJun 23, 2026Injury1119193-2026-00045
- MODERMAFLEX OSTOMY APPLIANCEJun 15, 2026Injury3016675012-2026-00004
- APOGEE ICJun 10, 2026Injury3008191244-2026-00006
Recalls
5 on file
- Open, ClassifiedFeb 19, 2025
Hollister received reports of decreased skin barrier wear time which could can lead to tube migration
View FDA record ↗ - Open, ClassifiedFeb 19, 2025
Hollister received reports of decreased skin barrier wear time which could can lead to tube migration
View FDA record ↗ - Open, ClassifiedFeb 19, 2025
Hollister received reports of decreased skin barrier wear time which could can lead to tube migration
View FDA record ↗ - Open, ClassifiedFeb 19, 2025
Hollister received reports of decreased skin barrier wear time which could can lead to tube migration
View FDA record ↗ - TerminatedUnknown
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.
View FDA record ↗
Compliance history
Matched by FEI 1119193.
FDA inspections
0 on file
No inspections on file for this FEI number.
Inspection citations
0 on file
No citations on file for this FEI number.
Compliance actions
0 on file
No warning letters or injunctions on file for this FEI number.
Import refusals
0 on file
No import refusals on file for this FEI number.