Class III — CellEra LLC
| Recalling firm | CellEra, LLC |
|---|---|
| Registered facility | CellEra, LLC (the firm's only registered facility) |
| Classification | Class III |
| Status | Terminated |
| Reason | Firm discovered that an incorrect version of the Instructions for Use (IFU) containing language beyond the cleared 510(k) were inserted in the affected products. Firm is replacing these with the correct version of the IFU. |
| Product | 20522 Vitale Silver calcium Alginate Dressings 2x2, 10/box |
| Quantity | 9200 ea |
| Distribution | US Nationwide distribution. |
| Initiated | 2021-12-15 |
| Classified | 2022-03-16 |
| Terminated | 2023-10-16 |
| Recall number | Z-0802-2022 |
| 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 III recall — CellEra LLC (Z-0802-2022).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/89453/
Alerts for CellEra, LLC
Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.
Want a one-page facility brief?
A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.