FDA Device recall Z-0078-2019
INSORB SUBCUTICULAR SKIN STAPLER, REF 2030
- FDA Device
- Class II
- terminated
- Published 2018-10-17
On 2018-10-17 the FDA classified a Class II recall of INSORB SUBCUTICULAR SKIN STAPLER, REF 2030 by Incisive Surgical, citing possible compromise of the sterile barrier integrity.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0078-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-08-29 |
| Published | 2018-10-17 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Incisive Surgical |
| Distribution | n/a |
Product
INSORB SUBCUTICULAR SKIN STAPLER, REF 2030
Reason
Possible compromise of the sterile barrier integrity
Identifiers
| code_info | UDI 10867516000101 Lot Number 182801 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0078-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.