WECK Visistat 35R Disposable Skin Stapler — Class II medical device recall Z-2108-2017
Completed recall by Teleflex Medical, reported 2017-05-24, distributed in CA, FL, GA, IL, IN, KS, KY, MA…. Some boxes are labeled as containing Visistat Wide devices, when they in fact they contained Visistat Regular
| Recall number | Z-2108-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Completed |
| Voluntary or mandated | Voluntary |
| Recalling firm | Teleflex Medical, Research Triangle Park, NC, United States |
| Recall initiated | 2017-03-24 |
| Classified | 2017-05-17 |
| Reported by FDA | 2017-05-24 |
| Distributed | CA, FL, GA, IL, IN, KS, KY, MA, MD, ME, MI, NC, NJ, NY, OH, OR, RI, TX, UT, VA |
| Countries outside the US | AU, BE, FR |
| Quantity | 3,594 eaches |
| Reason classes | labeling |
| Model numbers | 528135 |
Product
WECK Visistat 35R Disposable Skin Stapler, Ref 528135, Rx Only, Sterile EO, Visistat is indicated for the external skin closure of 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
Some boxes are labeled as containing Visistat Wide devices, when they in fact they contained Visistat Regular device.
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-2108-2017. 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.