The Recall Desk
SevereFDA (Devices)·Z-1855-2023·Announced 2023-07-05

Teleflex Flexi-Set Endotracheal Tubes Recalled for Connector Disconnection

Teleflex is recalling 32,553 units of Flexi-Set Uncuffed Endotracheal Tubes nationwide due to reports of 15mm connector disconnections that could compromise airway management.

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: FDA Class I classification requires a minimum severity score of 4. The source documents actual connector disconnections but does not report any patient injuries, illnesses, or deaths, placing this at Severe rather than Critical.

Plain-English summary

Teleflex LLC is recalling the Flexi-Set Uncuffed Endotracheal Tube and Stylet Set (REF 506530) due to reports of disconnection of the 15mm connector from the endotracheal tube. This disconnection could impair airway management during patient care.

The recalled product was distributed nationwide, including Puerto Rico. Approximately 32,553 units are affected, identified by UDI/DI 4026704547678 and specific batch numbers listed by the FDA.

Healthcare facilities and providers using this product should stop use and contact Teleflex with questions or to arrange replacement products. Patients or healthcare providers who believe they have experienced a connection failure should report the incident to Teleflex or contact the FDA.

The recalled product

Product
Flexi-Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 506530
Manufacturer
TELEFLEX LLC
Category
Medical Device — Airway Management / Endotracheal Tube
Hazard
Affected units
32,553

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 4026704547678
  • Batch Numbers: 18FG05
  • 18GG12
  • 18GG17
  • 18GG31
  • 18GT32
  • 18HG12
  • 18HG16
  • 18IG02
  • 18IG06
  • 18IG15
  • 18IG21
  • 18IG27
  • 18JG02
  • 18JG23
  • 18JG32
  • 18JG34
  • 18KG15
  • 18KG23
  • 18LG02

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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