VITALE Silicon Foam Dressings 4"x4" Cat — Class II medical device recall Z-2085-2019
Terminated recall by CellEra LLC, reported 2019-07-31, distributed in OH, PA, VA. Adhesive border was not sticky enough.
| Recall number | Z-2085-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | CellEra LLC, Monroe, OH, United States |
| Recall initiated | 2016-09-01 |
| Classified | 2019-07-25 |
| Reported by FDA | 2019-07-31 |
| Terminated | 2021-02-09 |
| Distributed | OH, PA, VA |
| Quantity | 2,110 units |
| Lot numbers | 161616, 20144 |
| Model numbers | 20144 |
Product
VITALE Silicon Foam Dressings 4"x4" Cat. No. 20144
Reason for recall
Adhesive border was not sticky enough.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2085-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.