FDA Medical Device Recalls (openFDA)
Teleflex Medical: 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
- Recall number
- Z-2108-2017
- Recalling firm
- Teleflex Medical
- 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
- Status
- Completed
- Initiated
- 2017-03-24
- Posted
- not on file
- Terminated
- not on file
- Reason
- Some boxes are labeled as containing Visistat Wide devices, when they in fact they contained Visistat Regular device.
- Root cause
- Error in labeling
- Action
- Teleflex sent an Urgent Medical Device Correction Notice dated March 24, 2017, to consignees. The letter requested that they check inventory on hand and quarantine product for return. They letter also requested that distributors conduct a sub-recall. The letter included a reply form to be returned. Customers with questions were instructed to contact their local sales representative or Customer Service at 1-866-246-6990.
- Quantity
- 3594 eaches
- Distribution
- Worldwide Distribution - US including CA, FL, GA, IL, IN, KS, KY, ME, MD, MA, MI, NJ, NY, NC, OH, OR, RI, TX, UT, VA, and Internationally to Australia, Belgium and France
- Lot, serial or model codes
- 73H1600207
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- GDT
- Firm FEI
- 3005747797
- Firm city
- Research Triangle Park
- Firm state
- NC
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28