WECK Visistat 35W — Class II medical device recall Z-0764-2017
Terminated recall by Teleflex Medical, reported 2016-12-21, distributed nationwide. Sterility Deficiency: The packages are not sealed properly and thus the sterility is not assured.
| Recall number | Z-0764-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Teleflex Medical, Research Triangle Park, NC, United States |
| Recall initiated | 2016-11-18 |
| Classified | 2016-12-14 |
| Reported by FDA | 2016-12-21 |
| Terminated | 2017-11-24 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BE, CA, CN, DE, HK, IN, JP, KR, MY, NZ, SG, TH |
| Reason classes | sterility |
| Lot numbers | 73C1600693, 73G1500681, 73H1500255, 73H1500256, 73K1500618, 73L1400006, 73M1500130 |
Product
WECK Visistat 35W, Disposable Skin Stapler, Rx Only, Sterile, Teleflex Medical, NC 27709. The intended use of the Visistat stapler is to close lacerations on the outer layer of the dermis for a wide range of general, thoracic, obstetric, gynecological, orthopedic, cardiovascular, urological, and plastic surgical procedures.
Reason for recall
Sterility Deficiency: The packages are not sealed properly and thus the sterility is not assured.
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-0764-2017. 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.