The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-1857-2023·Announced 2023-07-05

Flexi-Set Uncuffed Endotracheal Tubes recalled for connector disconnection risk

TELEFLEX LLC recalls Flexi-Set Uncuffed Endotracheal Tube and Stylet Sets due to reports of the 15mm connector disconnecting from the tube. Approximately 16,400 units distributed nationwide are affected.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: FDA Class I medical device recall. The connector disconnection can compromise airway management functionality, creating serious risk of patient harm during use. No deaths or serious injuries have been reported in the source material.

Plain-English summary

TELEFLEX LLC is recalling the Flexi-Set Uncuffed Endotracheal Tube and Stylet Set (oral/nasal, REF 506540), a medical device used for airway management. Reports indicate that the 15mm connector is disconnecting from the endotracheal tube in affected units. This connector disconnection could compromise the functionality of the airway management system, creating a serious risk of harm during use.

The recall affects approximately 16,400 units distributed nationwide, including Puerto Rico. These units are identified by UDI/DI 4026704547692 and are associated with specific batch numbers documented in the official FDA recall notice.

Healthcare facilities and medical professionals that have received these units should review the recall information and consult the FDA documentation for guidance on affected batch numbers and recommended actions.

The recalled product

Product
Flexi-Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 506540
Manufacturer
TELEFLEX LLC
Category
Medical Device
Hazard
Affected units
16,400

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 4026704547692
  • Batch Numbers: 18FG05
  • 18FG13
  • 18FG22
  • 18GG17
  • 18GG28
  • 18GT32
  • 18HG16
  • 18JG02
  • 18JG17
  • 18JG32
  • 18JG34
  • 18KG29
  • 18KG35
  • 18LG02
  • 18LG12
  • 18LG18
  • 18LG28
  • 19AG21
  • 19BG21

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 →

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