Hollister Incorporated
FDA Regulatory Profile
Hollister Incorporated appears in FDA public data with 5 recalls, 15 510(k) clearances, 6 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1179-2025, Class II) was initiated on December 23, 2024. Its most recent 510(k) clearance was granted on May 18, 2026.
Summary
- Total Recalls
- 5
- 510(k) Clearances
- 15
- Inspections
- 6
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1179-2025 | Class II | AnchorFast SlimFit, Oral Endotracheal Tube Fastener, REF 9787, | December 23, 2024 |
| Z-1178-2025 | Class II | AnchorFast Guard Select, Oral Endotracheal Tube Fastener, REF 9700, | December 23, 2024 |
| Z-1181-2025 | Class II | AnchorFast Guard, Oral Endotracheal Tube Fastener, REF 9800, | December 23, 2024 |
| Z-1180-2025 | Class II | AnchorFast, Oral Endotracheal Tube Fastener, REF 9799, | December 23, 2024 |
| Z-1311-2021 | Class II | Vertical Drain Tube Attachment Device (VTAD) (Gastrointestinal tube and accessories) - Product Usage | February 11, 2021 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K253295 | Coude Sleeved IC; Coude Plus Sleeved IC | May 18, 2026 |
| K251468 | Sleeved IC 3 Family Sleeved IC 3 SWT (name not finalized) Sleeved IC 3 Pocket (name not finalized) S | October 3, 2025 |
| K233524 | Sleeved IC 2 Family; Sleeved IC 2 SWT (Name not Finalized); Sleeved IC 2 Plus (Name not Finalized); | May 3, 2024 |
| K220667 | Sleeved IC | December 8, 2022 |
| K213575 | Female IC (Not Finalized) | September 13, 2022 |
| K211436 | Intermittent Catheter (Not Finalized) | January 27, 2022 |
| K193148 | VaPro Plus Pocket, VaPro Plus | December 13, 2019 |
| K191633 | Infyna Chic | July 19, 2019 |
| K183253 | ValPro 2 Plus, VaPro 2 Plus Pocket | December 18, 2018 |
| K180824 | VaPro 2 Intermittent Catheter | June 22, 2018 |
| K163179 | Onli Intermittent Catheter | January 26, 2017 |
| K152268 | VAPRO PLUS POCKET Intermittent Catheter | September 9, 2015 |
| K143594 | VaPro Pocket | January 9, 2015 |
| K141642 | VAPRO INTERMITTENT CATHETER | August 22, 2014 |
| K110862 | VAPRO PLUS INTERMITTENT CATHETER | April 26, 2011 |