Class II — CellEra LLC
| Recalling firm | CellEra, LLC |
|---|---|
| Registered facility | CellEra, LLC (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Adhesive border was not sticky enough. |
| Product | VITALE Silicon Foam Dressings 4"x4" Cat. No. 20144 |
| Quantity | 2110 units |
| Distribution | OH, PA, VA |
| Initiated | 2016-09-01 |
| Classified | 2019-07-25 |
| Terminated | 2021-02-09 |
| Recall number | Z-2085-2019 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — CellEra LLC (Z-2085-2019).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/83281/
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