Zip 8i Surgical Skin Closure Device — Class II medical device recall Z-1234-2015
Terminated recall by Zipline Medical, reported 2015-03-11, distributed nationwide. The manufacturers seal may not be present on the Nylon pouch resulting in lack of assurance for sterility.
| Recall number | Z-1234-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zipline Medical, Campbell, CA, United States |
| Recall initiated | 2015-02-05 |
| Classified | 2015-03-02 |
| Reported by FDA | 2015-03-11 |
| Terminated | 2015-04-10 |
| Distributed | Nationwide (US) |
| Countries outside the US | FI, HK, IE, JP, MY, PA, PK, SE, TW |
| Quantity | 3,109 |
| Reason classes | sterility, packaging |
| Lot numbers | 1002690, 2015-08 |
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 for recall
The manufacturers seal may not be present on the Nylon pouch resulting in lack of assurance for sterility.
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-1234-2015. 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.