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Hollister Incorporated

FDA Regulatory Profile

Summary

Total Recalls
5
510(k) Clearances
14
Inspections
6
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1180-2025Class IIAnchorFast, Oral Endotracheal Tube Fastener, REF 9799,December 23, 2024
Z-1178-2025Class IIAnchorFast Guard Select, Oral Endotracheal Tube Fastener, REF 9700,December 23, 2024
Z-1181-2025Class IIAnchorFast Guard, Oral Endotracheal Tube Fastener, REF 9800,December 23, 2024
Z-1179-2025Class IIAnchorFast SlimFit, Oral Endotracheal Tube Fastener, REF 9787,December 23, 2024
Z-1311-2021Class IIVertical Drain Tube Attachment Device (VTAD) (Gastrointestinal tube and accessories) - Product UsageFebruary 11, 2021

Recent 510(k) Clearances

K-NumberDeviceDate
K251468Sleeved IC 3 Family Sleeved IC 3 SWT (name not finalized) Sleeved IC 3 Pocket (name not finalized) SOctober 3, 2025
K233524Sleeved IC 2 Family; Sleeved IC 2 SWT (Name not Finalized); Sleeved IC 2 Plus (Name not Finalized); May 3, 2024
K220667Sleeved ICDecember 8, 2022
K213575Female IC (Not Finalized)September 13, 2022
K211436Intermittent Catheter (Not Finalized)January 27, 2022
K193148VaPro Plus Pocket, VaPro PlusDecember 13, 2019
K191633Infyna ChicJuly 19, 2019
K183253ValPro 2 Plus, VaPro 2 Plus PocketDecember 18, 2018
K180824VaPro 2 Intermittent CatheterJune 22, 2018
K163179Onli Intermittent CatheterJanuary 26, 2017
K152268VAPRO PLUS POCKET Intermittent CatheterSeptember 9, 2015
K143594VaPro PocketJanuary 9, 2015
K141642VAPRO INTERMITTENT CATHETERAugust 22, 2014
K110862VAPRO PLUS INTERMITTENT CATHETERApril 26, 2011