Agency classClass IIOur severity:High FDA (Devices)·Z-1326-2014·Announced 2014-04-09

Teleflex Medical Recalls Weck Vista Universal Cannulas Due to Gas Leakage

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

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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 involves a medical device with a functional defect (gas leakage) that poses a risk of harm to patients, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

Teleflex Medical is recalling 55,521 units of the 5/10 mm and 5/10/12 mm Weck Vista Universal Cannulas (Catalog Nos. 405910RC and 405912RC). The recall is due to complaints that the devices may leak insufflation gas.

The affected devices were distributed worldwide, including nationwide in the United States and Puerto Rico, as well as in Australia, Brazil, Canada, China, Israel, Korea, Malaysia, Singapore, and Vietnam. Specific lot numbers are listed in the official recall documentation.

Healthcare providers should stop using the affected cannulas and contact Teleflex Medical for instructions on how to return or dispose of the devices.

The recalled product

Product: 5/10 mm Weck Vista Universal Cannula, Catalog No. 405910RC; 5/10/12 mm Weck Vista Universal Cannula, Catalog No. 405912RC. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and…
Manufacturer: Teleflex Medical
Category: Medical Device — Endoscopy Accessories
Hazard: gas-leakage
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 (11)

Lots - Catalog No. 405910RC - 01J1200010
01J1200242
01K1200070
01A1300141
01B1300052
01D1300319
Catalog No. 405912RC - 01G1200244
01M1200020
01M1200068
01A1300546
01A1300559

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 →

Same manufacturer · Teleflex Medical

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Same hazard · gas leakage