CLASS II Device recall · Reported 24 May 2017 · FDA Enforcement Report

WECK Visistat 35R Disposable Skin Stapler recalled by Teleflex Medical

Teleflex Medical is recalling WECK Visistat 35R Disposable Skin Stapler, distributed nationwide in the US. The recall was initiated on 24 Mar 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes73H1600207

Quantity recalled3594 eaches

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2108-2017
FDA event ID: 77102
Recalling firm: Teleflex Medical, Research Triangle Park, NC
Classification: Class II
Status: Completed
Recall initiated: 24 Mar 2017
FDA classified: 17 May 2017
Reported: 24 May 2017
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Foreign Material
Device type: Heart & Vascular Devices

Timeline

24 Mar 2017	Recall initiated by company
17 May 2017	Classified by FDA	+54 days
24 May 2017	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Some boxes are labeled as containing Visistat Wide devices, when they in fact they contained Visistat Regular device.

Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.

Product as listed by the FDA

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

Where it was distributed

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

Nationwide California Florida Georgia Illinois Indiana Kansas Kentucky Massachusetts Maryland Maine Michigan North Carolina New Jersey New York Ohio Oregon Rhode Island Texas Utah Virginia

Questions about this recall

Is WECK Visistat 35R Disposable Skin Stapler recalled?

Yes. Teleflex Medical recalled WECK Visistat 35R Disposable Skin Stapler on 24 Mar 2017. The recall is Class II and its status is Completed. Recall number Z-2108-2017.

Why was it recalled?

Some boxes are labeled as containing Visistat Wide devices, when they in fact they contained Visistat Regular device.

Which lots are affected?

73H1600207

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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