SeriScaffold Surgical Scaffold Product Number: SCF10X25AGEN — Class II medical device recall Z-0794-2013
Terminated recall by Allergen Medical, reported 2013-02-13, distributed in CA, FL, GA, MI, MN, NJ, NY, OH…. Product is dual packaged in an inner and outer pouch, the outer pouch seal may be compromised and sterility ma
| Recall number | Z-0794-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Allergen Medical, Medford, MA, United States |
| Recall initiated | 2013-01-08 |
| Classified | 2013-02-07 |
| Reported by FDA | 2013-02-13 |
| Terminated | 2013-07-29 |
| Distributed | CA, FL, GA, MI, MN, NJ, NY, OH, OR, RI, TX, VA, WA |
| Countries outside the US | DE, ES, GB |
| Reason classes | sterility, packaging |
| Lot numbers | P2012040901 |
Product
SeriScaffold Surgical Scaffold Product Number: SCF10X25AGEN. Surgical mesh for use in open or laparoscopic procedures.
Reason for recall
Product is dual packaged in an inner and outer pouch, the outer pouch seal may be compromised and sterility may not be assured
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-0794-2013. 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.