INSORB SUBCUTICULAR SKIN STAPLER — Class II medical device recall Z-0078-2019
Terminated recall by Incisive Surgical Inc, reported 2018-10-17. Possible compromise of the sterile barrier integrity
| Recall number | Z-0078-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Incisive Surgical Inc, Plymouth, MN, United States |
| Recall initiated | 2018-08-29 |
| Classified | 2018-10-05 |
| Reported by FDA | 2018-10-17 |
| Terminated | 2019-03-18 |
| Countries outside the US | IL |
| Quantity | 1,200 units |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 10867516000101 |
| Lot numbers | 182801 |
| Model numbers | 2030 |
Product
INSORB SUBCUTICULAR SKIN STAPLER, REF 2030
Reason for recall
Possible compromise of the sterile barrier integrity
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-0078-2019. 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.