The Recall Desk
HighFDA (Devices)·Z-1761-2019·Announced 2019-06-26

Teleflex Recalls Hudson RCI Sheridan Endotracheal Tubes Due to Disconnection

Teleflex Medical is voluntarily recalling specific lots of Hudson RCI Sheridan EZ-ENDO 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 connector disconnection could lead to loss of airway, a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Teleflex Medical is voluntarily recalling 55,312 units of Hudson RCI Sheridan EZ-ENDO endotracheal tubes in six sizes (6.0 mm, 6.5 mm, 7.0 mm, 7.5 mm, 8.0 mm, and 8.5 mm). The recall covers specific product codes and lot numbers distributed worldwide and across the United States.

The recall is due to reported complaints indicating an increased incidence of the 15 mm Sheridan connector becoming disconnected from the endotracheal tube. The source text notes that these complaints represent less than 0.0025% of all in-scope distributed product.

Healthcare providers and facilities should check their inventory for the specific product codes and lot numbers listed in the recall notice. If the affected products are found, they should be removed from use and returned to Teleflex Medical or the authorized distributor.

The recalled product

Product
Hudson RCI Sheridan: 1) EZ-ENDO 6.0 mm, Product Code 5-22512 2) EZ-ENDO 6.5 mm, Product Code 5-22513 3) EZ-ENDO 7.0 mm, Product Code 5-22514 4) EZ-ENDO 7.5 mm, Product Code 5-22515 5) EZ-ENDO 8.0 mm, Product Code 5-22516 6) EZ-ENDO 8.5 mm, Product Code 5-22517 Product Us
Manufacturer
Teleflex Medical
Category
Medical Device — Airway Management
Hazard
Affected units
55,312

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 (2)

  • 1) EZ-ENDO 6.0 mm
  • Product Code 5-22517 Lot Numbers: 73J1600767 73C1800202

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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