Superstat Modified Collagen Hemostatic Sponge — Class II medical device recall Z-0342-2013
Terminated recall by Superstat Corp, reported 2012-11-28, distributed nationwide. The recall was initiated because Superstat Corporation has confirmed that no documentation are available to ve
| Recall number | Z-0342-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Superstat Corp, Rancho Dominguez, CA, United States |
| Recall initiated | 2012-10-24 |
| Classified | 2012-11-16 |
| Reported by FDA | 2012-11-28 |
| Terminated | 2013-02-06 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, GR, IL, MX, PK, RS, SA, SG, TH |
| Quantity | 26,422 units |
| Reason classes | sterility |
| Lot numbers | SSN02D |
| Model numbers | 9100-30 |
Product
Superstat Modified Collagen Hemostatic Sponge, 32mm Disc, 3.0%, Part# 9100-30. For use when hemostasis is desired along suture lines, in diffusely bleeding sites, in incisions, dissections, and around arterial or venous anastomoses. Indicated in oozing bleeding, either capillary or venous, in almost all types of incisions or wounds, and as an adjunct to conventional closure techniques
Reason for recall
The recall was initiated because Superstat Corporation has confirmed that no documentation are available to verify that quarterly dose sterility audits were performed for the Superstat Modified Collagen Hemostatic Sponge.
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-0342-2013. 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.