The Recall Desk
SevereFDA (Devices)·Z-1856-2023·Announced 2023-07-05

Flexi-Set Endotracheal Tube Recalled for Connector Disconnection

Teleflex is recalling 18,353 Flexi-Set Uncuffed Endotracheal Tube sets nationwide due to reports of 15mm connector disconnection. The defect could affect ventilation during use.

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: This is an FDA Class I recall, which mandates a minimum severity score of 4. The defect involves potential disconnection of a critical airway connector. While no illnesses or deaths have been reported, the inherent risk to ventilated patients justifies the Severe classification.

Plain-English summary

Teleflex LLC is recalling the Flexi-Set Uncuffed Endotracheal Tube and Stylet Set (oral/nasal, model REF 506535) nationwide, including Puerto Rico. The recall affects approximately 18,353 units distributed in the United States.

The FDA has classified this as a Class I recall due to reports of disconnection of the 15mm connector from the endotracheal tube. This defect could compromise the connection between the airway tube and ventilation equipment during patient use.

Patients or healthcare providers who have received or are using one of the affected products should discontinue use and contact Teleflex for instructions on replacement or return. Facilities should check their inventory against the provided batch numbers to identify affected units.

To determine if your product is affected, refer to the UDI/DI number 4026704547685 and the batch numbers listed in the original FDA notice. If you have questions or need replacement units, contact Teleflex LLC directly.

The recalled product

Product
Flexi-Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 506535
Manufacturer
TELEFLEX LLC
Category
Medical Device — Airway Equipment
Hazard
Affected units
18,353

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 4026704547685
  • Batch Numbers: 18FG05
  • 18FG20
  • 18GG12
  • 18GG17
  • 18GG28
  • 18GT32
  • 18HG12
  • 18HG16
  • 18JG17
  • 18KG07
  • 18LG02
  • 18LG22
  • 18LG28
  • 19AG21
  • 19BG40
  • 19CT58
  • 19ET38
  • 19ET60
  • 19ET72

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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