FDA Device recall Z-1234-2015
Zip 8i Surgical Skin Closure Device
- FDA Device
- Class II
- terminated
- Published 2015-03-11
On 2015-03-11 the FDA classified a Class II recall of Zip 8i Surgical Skin Closure Device by Zipline Medical, citing the manufacturers seal may not be present on the Nylon pouch resulting in lack of assurance for sterility.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1234-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-02-05 |
| Published | 2015-03-11 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Zipline Medical |
| Distribution | US |
Product
Zip 8i Surgical Skin Closure Device; for incisions up to 8 cm. Product number PS2080 Indicated for use during and after skin incision procedures to approximate skin and hold together skin edges until healing can take place.
Reason
The manufacturers seal may not be present on the Nylon pouch resulting in lack of assurance for sterility.
Identifiers
| code_info | Lot 1002690, Exp 2015-08 |
|---|
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-1234-2015%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.