FDA Device recall Z-0794-2013
SeriScaffold Surgical Scaffold Product Number: SCF10X25AGEN. Surgical mesh for use in open or laparoscopic procedures
- FDA Device
- Class II
- terminated
- Published 2013-02-13
On 2013-02-13 the FDA classified a Class II recall of SeriScaffold Surgical Scaffold Product Number: SCF10X25AGEN. Surgical mesh for use in open or laparoscopic procedures by Allergen Medical, citing product is dual packaged in an inner and outer pouch, the outer pouch seal may be compromised and sterility may not be assured.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0794-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-01-08 |
| Published | 2013-02-13 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Allergen Medical |
| Distribution | CA, FL, GA, MI, MN, NJ, NY, OH, OR, RI, TX, VA, WA |
Product
SeriScaffold Surgical Scaffold Product Number: SCF10X25AGEN. Surgical mesh for use in open or laparoscopic procedures.
Reason
Product is dual packaged in an inner and outer pouch, the outer pouch seal may be compromised and sterility may not be assured
Identifiers
| code_info | Lot Numbers: P2012040901 (US) P2011080101B and P2011090901A (Outside the US) |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0794-2013%22
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