The Recall Desk
HighFDA (Devices)·Z-1766-2019·Announced 2019-06-26

Teleflex Recalls Sheridan Novaplus Endotracheal Tubes Due to Connector Disconnection

Teleflex Medical is voluntarily recalling specific lots of Sheridan Novaplus endotracheal tubes because the 15 mm Sheridan connector may disconnect from the tube.

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 involves a medical device used for airway management where a defect (connector disconnection) poses a risk of harm, but the source does not report specific injuries or fatalities, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

Teleflex Medical is voluntarily recalling specific lots of Sheridan Novaplus endotracheal tubes in sizes 7.0 mm, 7.5 mm, 8.0 mm, and 8.5 mm. The recall is due to reported complaints indicating an increased incidence of the 15 mm Sheridan connector becoming disconnected from the endotracheal tube.

The affected product is used for tracheal tube and airway management. The source text notes that the complaints represent less than 0.0025% of all in-scope distributed product. The recall covers 1,390,944 units distributed worldwide and nationwide in the US.

Healthcare facilities and consumers should check their inventory for the specific product codes and lot numbers listed in the official recall notice. If the product is found, it should be removed from use and returned to Teleflex Medical or the distributor according to the recall instructions.

The recalled product

Product
Sheridan/HVT: 1) Novaplus 7.0 mm, Product Code V5-10314 2) Novaplus 7.5 mm, Product Code V5-10315 3) Novaplus 8.0 mm, Product Code V5-10316 4) Novaplus 8.5 mm, Product Code V5-10317 Product Usage: Tracheal tube/airway management
Manufacturer
Teleflex Medical
Category
Medical Device — Airway Management
Hazard
Affected units
1,390,944

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 (1)

  • 1) Novaplus 7.0 mm

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 8 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 8 products in this recall →

Related recalls

Same manufacturer · Teleflex Medical

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Same hazard · disconnection

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