HeliTape Absorbable Collagen Wound Dressing for Dental Surgery The… — Class II medical device recall Z-1294-2013
Terminated recall by Integra LifeSciences Corporation, reported 2013-05-22, distributed nationwide. Due to the process deviation, product lots in question may have been released with higher levels of pyrogens t
| Recall number | Z-1294-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Integra LifeSciences Corporation, Plainsboro, NJ, United States |
| Recall initiated | 2013-03-28 |
| Classified | 2013-05-10 |
| Reported by FDA | 2013-05-22 |
| Terminated | 2015-06-03 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, BE, CA, CL, CN, CR, DK, EG, ES, FR, GB, IT, JP, PE, SG, TH, ZA |
| Quantity | 19,030 boxes |
| Reason classes | sterility |
Product
HeliTape Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen Wound Dressings for Dental Surgery are intended for use on moist or bleeding oral wounds where a stabilized blood clot can help protect the surface of the wound from further injury. Topical administration of the Absorbable Collagen Wound Dressings directly over the wound effectively controls bleeding usually within two to five minutes.
Reason for recall
Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products.
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-1294-2013. 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.