The Recall Desk
SevereFDA (Devices)·Z-1845-2023·Announced 2023-07-05

Flexi-Set Cuffed Endotracheal Tube Recall: Connector Disconnection Risk

Teleflex is recalling Flexi-Set Cuffed Endotracheal Tubes due to reports of 15mm connector disconnection. The recall affects 66,310 units distributed nationwide.

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 indicates a serious hazard with an airway management device. Although no illnesses or injuries have been reported, connector disconnection presents significant risk of patient harm. FDA Class I recalls are scored at minimum Severe (4) per rubric guidance.

Plain-English summary

Teleflex is recalling the Flexi-Set Cuffed Endotracheal Tube and Stylet Set (REF 504550) for oral and nasal intubation due to reports of 15mm connector disconnection from the endotracheal tube.

The recall affects 66,310 units distributed nationwide in the United States and Puerto Rico. Affected devices are identified by UDI/DI 4026704547579 and include 62 batch numbers produced between 2018 and 2022.

Healthcare facilities and providers should immediately stop using affected units and contact Teleflex for replacement, credit, or other instructions. Verify batch numbers against the recall list to determine if your units are affected.

The recalled product

Product
Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 504550
Manufacturer
TELEFLEX LLC
Category
Medical Device — Airway Management
Hazard
Affected units
66,310

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 4026704547579
  • Batch Numbers: 18FG03
  • 18FG13
  • 18GG12
  • 18GG17
  • 18GG31
  • 18HG12
  • 18IG02
  • 18IG12
  • 18IG21
  • 18IG27
  • 18JG02
  • 18KG15
  • 18LG25
  • 18LG37
  • 19AG37
  • 19BG07
  • 19BG21
  • 19CT71
  • 19ET54

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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