Staple, Removable (Skin)
FDA adverse event reports and recall history for staple, removable (skin) (product code GDT), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 4,740
- Deaths
- 2
- Injuries
- 259
- Malfunctions
- 4,443
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2015-09-03TerminatedPackaging
SKIN STAPLE REMOVER KIT 80/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
- 2014-12-16TerminatedPackaging
Skin Staple Removal, Catalog number 900-782. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.
- TerminatedPackaging process control
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.
Sterility Deficiency: The packages are not sealed properly and thus the sterility is not assured.
- TerminatedPackaging process control
Teleflex MEDICAL WECK Visistat 35. Used for the external skin closure of lacerations.
Some boxes are labeled as Visistat Wide devices, when in fact the contain Visistat Regular devices. The 6 individually packaged units within the boxes are correctly labeled.
- CompletedError in labeling
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
Some boxes are labeled as containing Visistat Wide devices, when they in fact they contained Visistat Regular device.
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