The Recall Desk
SevereFDA (Devices)·Z-1853-2023·Announced 2023-07-05

Flexi-Set Cuffed Endotracheal Tube and Stylet Connector Disconnection Recall

TELEFLEX LLC is recalling 13,710 units of Flexi-Set Cuffed Endotracheal Tubes due to reports of connector disconnection. The 15mm connector may separate from the tube 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: FDA Class I medical device recall per agency classification. The rubric mandates Class I recalls be scored no lower than Severe (4), regardless of reported injury status.

Plain-English summary

TELEFLEX LLC is recalling Flexi-Set Cuffed Endotracheal Tube and Stylet Set (REF 504590) due to reports of disconnection of the 15mm connector from the endotracheal tube. The recall affects 13,710 units distributed nationwide, including Puerto Rico.

The reported issue involves separation of the 15mm connector from the tube. This defect has been classified as a Class I recall by the FDA, indicating the defect presents a serious hazard.

Affected devices carry the UDI/DI 4026704547654 and specific batch numbers. Healthcare providers should immediately stop using affected units and contact TELEFLEX LLC for instructions regarding return, replacement, or alternative options.

The recalled product

Product
Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 504590
Manufacturer
TELEFLEX LLC
Category
Medical Device — Airway Management
Hazard
Affected units
13,710

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 4026704547654
  • Batch Numbers: 18FG18
  • 18FG20
  • 18GG17
  • 18GT32
  • 18HG12
  • 18HG27
  • 18HG38
  • 18IG15
  • 18IG30
  • 18KG03
  • 18KG07
  • 18KG35
  • 18LG18
  • 19AG24
  • 19AG27
  • 19BG04
  • 19DT38
  • 19DT45
  • 19ET32

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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