The Recall Desk
HighFDA (Devices)·Z-2311-2019·Announced 2019-09-18

Teleflex Recalls Sheridan LTS Tracheal Tubes Due to Disconnection Risk

Teleflex Medical is recalling specific lots of Sheridan LTS tracheal tubes because the 15 mm 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 risk-of-harm product (airway management) where disconnection may result in insufficient oxygenation requiring medical intervention, but no specific injuries or illnesses are reported in the source text.

Plain-English summary

Teleflex Medical is recalling 7,963 units of Hudson RCI Sheridan LTS tracheal tubes (sizes 4.0 mm, 5.0 mm, and 6.0 mm) distributed nationwide in the United States. The recall involves specific batch numbers for reference numbers 5-11108, 5-11110, and 5-11112.

The recall was initiated because reported complaints indicate an increased incidence of the 15 mm Sheridan connector becoming disconnected from the endotracheal tube. This disconnection from the breathing circuit may result in insufficient oxygenation, which could require medical intervention.

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

The recalled product

Product
Hudson RCI Sheridan LTS: a) 4.0 mm, REF 5-11108 b) 5.0 mm, REF 5-11110 c) 6.0 mm, REF 5-11112 Product Usage: Tracheal tube/airway management
Manufacturer
Teleflex Medical
Affected units
7,963

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 →