The Recall Desk
HighFDA (Devices)·Z-1323-2014·Announced 2014-04-09

Teleflex Recalls Weck Vista Universal Laparoscopic Ports Due to Gas Leakage

Teleflex Medical is recalling 55,521 Weck Vista Universal Laparoscopic Ports worldwide because they may leak insufflation gas during use.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a functional defect (gas leakage) in a medical device used in surgical procedures, which poses a risk of harm even though specific injuries are not detailed in the source text.

Plain-English summary

Teleflex Medical is recalling 55,521 units of Weck Vista Universal Laparoscopic Ports, including sizes 5/10mm x 100mm, 5/10/12mm x 100mm, and 5/10/12mm x 125mm. The affected catalog numbers are 405910, 405912, and 40591213. These devices are used to provide access, illumination, and observation of body cavities during laparoscopic procedures.

The recall was initiated due to complaints of leakage of insufflation gas through the device. The affected units were distributed worldwide, including the United States (nationwide, including Puerto Rico) and several international markets such as Australia, Brazil, Canada, China, Israel, Korea, Malaysia, Singapore, and Vietnam.

Healthcare providers and facilities should stop using the affected devices and contact Teleflex Medical for further instructions on returns or replacements. Patients who have had procedures using these devices should consult their healthcare provider if they have concerns.

The recalled product

Product
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 accessori
Manufacturer
Teleflex Medical
Category
Medical Device — Surgical Instruments
Hazard
Affected units
55,521

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • Lots  Catalog No. 405910 - 01G1200242
  • 01G1200242
  • 01G1200341
  • 01J1200100
  • 01J1200378
  • 01J1200461
  • 01K1200266
  • 01K1200171
  • 01L1200182
  • 01A1300139
  • 01B1300050
  • 01D1300318
  • 01E1300139
  • 01E1300217
  • 01E1300432
  • Catalog No. 405912  01J1200462
  • 01K1200129
  • 01K1200377
  • 01K1200596
  • 01K1200611

Distribution

Distributed nationwide across the United States.

The notice also names 34 states specifically:

Part of a larger recall action

This product is one of 6 recalled by Teleflex Medical under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 6 products in this recall →

Related recalls

Same manufacturer · Teleflex Medical

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Same hazard · gas leakage

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