ActCel advanced bleeding control Topical Hemostatic Dressing 2in X 2in — Class II medical device recall Z-1697-2015
Terminated recall by Coreva Health Science LLC, reported 2015-06-10, distributed in AZ, FL, NY, TX, VA, WA. Coreva Health Science, LLC. is recalling ActCel Hemostatic Dressing due to customer literature and web sites p
| Recall number | Z-1697-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Coreva Health Science LLC, Westlake Village, CA, United States |
| Recall initiated | 2015-05-18 |
| Classified | 2015-05-30 |
| Reported by FDA | 2015-06-10 |
| Terminated | 2015-08-26 |
| Distributed | AZ, FL, NY, TX, VA, WA |
| Quantity | 180,900 |
Product
ActCel advanced bleeding control Topical Hemostatic Dressing 2in X 2in (5cm X 5cm) 4in X 4in Sterile Contents Soluble Regenerated Cellulose For Bleeding Control For external topical and temporary use only Sterility of contents guaranteed unless individual envelope is damaged or opened. Store at room temperature (41F-104F). Do not autoclave.
Reason for recall
Coreva Health Science, LLC. is recalling ActCel Hemostatic Dressing due to customer literature and web sites promoting that it can help control bleeding from open wounds and in body cavities. ActCel is indicated as a prescription device for management of topical wounds and to temporarily control external surface bleeding.
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-1697-2015. 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.