FDA Device recall Z-2085-2019
VITALE Silicon Foam Dressings 4"x4" Cat
- FDA Device
- Class II
- terminated
- Published 2019-07-31
On 2019-07-31 the FDA classified a Class II recall of VITALE Silicon Foam Dressings 4"x4" Cat by Cellera, citing adhesive border was not sticky enough.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2085-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-09-01 |
| Published | 2019-07-31 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Cellera |
| Distribution | OH, PA, VA |
Product
VITALE Silicon Foam Dressings 4"x4" Cat. No. 20144
Reason
Adhesive border was not sticky enough.
Identifiers
| code_info | Lot # 161616 Cat. No. 20144 HIBCC bar code was M6692014409 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2085-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.