CLASS II Device recall · Reported 9 Apr 2014 · FDA Enforcement Report

Weck Vista Universal Laparoscopic Port, Size recalled

Teleflex Medical is recalling Weck Vista Universal Laparoscopic Port, Size, distributed nationwide in the US. The recall was initiated on 11 Mar 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLots Catalog No. 405910 - 01G1200242, 01G1200242, 01G1200341, 01J1200100, 01J1200100, 01J1200378, 01J1200461, 01K1200266, 01K1200171, 01K1200266, 01L1200182, 01A1300139, 01A1300139, 01B1300050, 01D1300318, 01E1300139, 01E1300217, 01E1300432; Catalog No. 405912 01J1200462, 01K1200129, 01K1200377, 01K1200596, 01K1200611, 01K1200611, 01L1200369, 01L1200369, 01L1200369, 01A1300106, 01A1300106, 01A1300106, 01E1300218, 01E1300311, 01F1300135, 01F1300079; Catalog No. 40591213- 01J1200416, 01K1200612, 01L1200160, 01A1300418, 01A1300427, 01E1300056, 01E1300052, 01E1300055

Quantity recalled55,521 total

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-1323-2014
FDA event ID: 67819
Recalling firm: Teleflex Medical, Durham, NC
Classification: Class II
Status: Terminated
Recall initiated: 11 Mar 2014
FDA classified: 2 Apr 2014
Reported: 9 Apr 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Surgical Instruments

Timeline

11 Mar 2014	Recall initiated by company
2 Apr 2014	Classified by FDA	+22 days
9 Apr 2014	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

Complaints of leakage of insufflation gas through the device.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

Weck Vista Universal Laparoscopic Port, Size 5/10mm x 100mm, Catalog No. 405910, Weck Vista Universal Laparoscopic Port, Size 5/10/12mm x 100mm, Catalog No. 405912; Weck Vista Universal Laparoscopic Port, Size 5/10/12mm x 125mm, Catalog No. 40591213. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals.

Where it was distributed

Worldwide Distribution-USA (nationwide) including Puerto Rico and the states of AL, AZ, AR, CA, CO, CT, FL, GA, IL, IN, KS, KY, MD, MA, MI, MN, MS, MO, NH, NJ, NY, NC, ND, OH, OR, PA, SC, TN, UT, VA, WA, WV, WI and the countries of Australia, Brazil, Canada, China, Israel, Korea, Malaysia, Singapore, and Vietnam.

Nationwide Alabama Arkansas Arizona California Colorado Connecticut Florida Georgia Illinois Indiana Kansas Kentucky Massachusetts Maryland Michigan Minnesota Missouri Mississippi North Carolina North Dakota

Questions about this recall

Why was it recalled?

Complaints of leakage of insufflation gas through the device.

Which lots are affected?

Lots Catalog No. 405910 - 01G1200242, 01G1200242, 01G1200341, 01J1200100, 01J1200100, 01J1200378, 01J1200461, 01K1200266, 01K1200171, 01K1200266, 01L1200182, 01A1300139, 01A1300139, 01B1300050, 01D1300318, 01E1300139, 01E1300217, 01E1300432; Catalog No. 405912 01J1200462, 01K1200129, 01K1200377, 01K1200596, 01K1200611, 01K1200611, 01L1200369, 01L1200369, 01L1200369, 01A1300106, 01A1300106, 01A1300106, 01E1300218, 01E1300311, 01F1300135, 01F1300079; Catalog No. 40591213- 01J1200416, 01K1200612, 01L1200160, 01A1300418, 01A1300427, 01E1300056, 01E1300052, 01E1300055

Where was it sold?

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

Other products in this recall event

5 other products · FDA event 67819

This product is part of a recall event; the main page for the event is Weck Vista Optical Bladeless Laparoscopic Access Port recalled.

Reported	Class	Recall	Company	Reason	Where
9 Apr 2014	CLASS II	Weck Vista Optical Bladeless Laparoscopic Access Port recalled	Teleflex Medical	Packaging Defects	Nationwide
9 Apr 2014	CLASS II	Weck Vista Cannula-only recalled by Teleflex Medical	Teleflex Medical	Packaging Defects	Nationwide
9 Apr 2014	CLASS II	Weck Vista Universal Cone Open Access recalled by Teleflex Medical	Teleflex Medical	Packaging Defects	Nationwide
9 Apr 2014	CLASS II	Weck Vista Universal Cannula recalled by Teleflex Medical	Teleflex Medical	Packaging Defects	Nationwide
9 Apr 2014	CLASS II	5/10 Weck Vista Universal Balloon Open Access Port - Standard Length recalled	Teleflex Medical	Packaging Defects	Nationwide

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