CLASS II Device recall · Reported 21 Dec 2016 · FDA Enforcement Report

WECK Visistat 35W, Disposable Skin Stapler recalled by Teleflex Medical

Teleflex Medical is recalling WECK Visistat 35W, Disposable Skin Stapler, distributed nationwide in the US. The recall was initiated on 18 Nov 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesProduct Code: 528235, Lot numbers: 73C1600693, 73G1500681, 73H1500255, 73H1500256, 73K1500618, 73L1400006 and 73M1500130.

Quantity recalled96,402 units (9,120 ea US, 87,282 ea OUS)

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-0764-2017
FDA event ID: 75735
Recalling firm: Teleflex Medical, Research Triangle Park, NC
Classification: Class II
Status: Terminated
Recall initiated: 18 Nov 2016
FDA classified: 14 Dec 2016
Reported: 21 Dec 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Foreign Material
Device type: Heart & Vascular Devices

Timeline

18 Nov 2016	Recall initiated by company
14 Dec 2016	Classified by FDA	+26 days
21 Dec 2016	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

Sterility Deficiency: The packages are not sealed properly and thus the sterility is not assured.

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 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.

Where it was distributed

Worldwide Distribution- U.S. (Nationwide) and countries of: Australia, Belgium, Canada, China, Germany, Hong Kong, India, Japan, Korea, Malaysia, New Zealand, Singapore and Thailand.

Nationwide

Questions about this recall

Is WECK Visistat 35W, Disposable Skin Stapler recalled?

Yes. Teleflex Medical recalled WECK Visistat 35W, Disposable Skin Stapler on 18 Nov 2016. The recall is Class II and its status is Terminated. Recall number Z-0764-2017.

Why was it recalled?

Sterility Deficiency: The packages are not sealed properly and thus the sterility is not assured.

Which lots are affected?

Product Code: 528235, Lot numbers: 73C1600693, 73G1500681, 73H1500255, 73H1500256, 73K1500618, 73L1400006 and 73M1500130.

Where was it sold?

Worldwide Distribution- U.S. (Nationwide) and countries of: Australia, Belgium, Canada, China, Germany, Hong Kong, India, Japan, Korea, Malaysia, New Zealand, Singapore and Thailand.

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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