FDA Device recall Z-2108-2017
WECK Visistat 35R Disposable Skin Stapler, Ref 528135, Rx Only, Sterile EO, Visistat is indicated for the external skin closure of lacerati…
- FDA Device
- Class II
- completed
- Published 2017-05-24
On 2017-05-24 the FDA classified a Class II recall of WECK Visistat 35R Disposable Skin Stapler, Ref 528135, Rx Only, Sterile EO, Visistat is indicated for the external skin closure of lacerati… by Teleflex Medical, citing some boxes are labeled as containing Visistat Wide devices, when they in fact they contained Visistat Regular device.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2108-2017 |
| Classification | Class II |
| Status | completed |
| Initiated | 2017-03-24 |
| Published | 2017-05-24 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Teleflex Medical |
| Distribution | CA, FL, GA, IL, IN, KS, KY, MA, MD, ME, MI, NC, NJ, NY, OH, OR, RI, TX, UT, VA |
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
Some boxes are labeled as containing Visistat Wide devices, when they in fact they contained Visistat Regular device.
Identifiers
| code_info | 73H1600207 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: completed.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2108-2017%22
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