The Recall Desk
HighFDA (Devices)·Z-2318-2019·Announced 2019-09-18

Teleflex Recalls Sheridan/HVT Novaplus Tracheal Tubes Due to Disconnection Risk

Teleflex Medical is recalling specific lots of Sheridan/HVT Novaplus tracheal tubes because the 15 mm Sheridan connector may disconnect from the tube, potentially causing insufficient oxygenation.

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 where disconnection may result in insufficient oxygenation requiring medical intervention, representing a risk of harm where specific injury counts are not reported in the source text.

Plain-English summary

Teleflex Medical is recalling 1,391,004 units of Sheridan/HVT Novaplus tracheal tubes (sizes 7.0 mm, 7.5 mm, 8.0 mm, and 8.5 mm) distributed nationwide in the United States. The recall involves specific batch numbers for each size, which are listed in the official FDA recall notice Z-2318-2019.

The recall was initiated because reported complaints indicate an increased incidence of the 15 mm Sheridan connector becoming disconnected from the endotracheal tube. If the connector disconnects from the breathing circuit, it may result in insufficient oxygenation for the patient, which would require medical intervention.

Healthcare facilities and consumers should check their inventory for the specific reference numbers and batch numbers listed in the FDA recall notice. If the product is found, it should be removed from use and returned to Teleflex Medical or the distributor in accordance with the recall instructions.

The recalled product

Product
Sheridan/HVT Novaplus: a) 7.0 mm, REF V5-10314 b) 7.5 mm, REF V5-10315 c) 8.0 mm, REF V5-10316 d) 8.5 mm, REF V5-10317 Product Usage: Tracheal tube/airway management
Manufacturer
Teleflex Medical
Category
Medical Device — Airway Management
Hazard
Affected units
1,391,004

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)

  • a) 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

See all →

Same hazard · disconnection

See all →