The Recall Desk
SevereFDA (Devices)·Z-1854-2023·Announced 2023-07-05

Flexi-Set Endotracheal Tubes Recalled for 15mm Connector Disconnection

Teleflex is recalling 17,551 units of Flexi-Set Uncuffed Endotracheal Tubes nationwide after reports of the 15mm connector disconnecting from the tube.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The FDA classified this as a Class I recall, which requires a minimum severity score of 4. Although no deaths, serious injuries, or illnesses are reported in the source, connector disconnection on a critical airway management device poses significant patient safety risk.

Plain-English summary

Teleflex LLC is recalling the Flexi-Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal (REF 506525), with UDI/DI 4026704547661. The recall affects approximately 17,551 units distributed nationwide, including Puerto Rico, across multiple batch numbers manufactured from 2018 through 2022.

The FDA initiated this Class I recall following reports of disconnection of the 15mm connector from the endotracheal tube. Endotracheal tubes are medical devices used for airway management in surgical and intensive care settings.

Affected batch numbers include units from lots 18FG05 through 20FT44 and KME20L0615 through KME22L0760. Healthcare facilities that have received affected units should identify them by batch number and cease use of affected batches.

Healthcare providers should contact Teleflex LLC for guidance on handling, return, or disposal of the affected devices.

The recalled product

Product
Flexi-Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 506525
Manufacturer
TELEFLEX LLC
Category
Medical Device — Airway Management
Hazard
Affected units
17,551

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 (20)

  • UDI/DI 4026704547661
  • Batch Numbers: 18FG05
  • 18FG13
  • 18GG17
  • 18GG28
  • 18HG16
  • 18HG25
  • 18HG29
  • 18HG35
  • 18HG38
  • 18IG06
  • 18IG12
  • 18IG24
  • 18IG27
  • 18JG11
  • 18JG14
  • 18JG26
  • 18JG34
  • 18KG23
  • 18LG05

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 123 recalled by TELEFLEX LLC 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 123 products in this recall →

Related recalls

Same manufacturer · TELEFLEX LLC

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Same hazard · connector disconnection

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