The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-1859-2023·Announced 2023-07-05

Flexi-Set Uncuffed Endotracheal Tube Sets recalled for connector disconnection

Teleflex is recalling approximately 10,600 Flexi-Set Uncuffed Endotracheal Tube and Stylet Sets due to reports that the 15mm connector may disconnect from the tube during use.

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. Per classification rules, FDA Class I recalls score no lower than 4. The hazard—connector disconnection from a critical airway device—poses significant risk during patient ventilation.

Plain-English summary

Teleflex LLC is recalling approximately 10,600 Flexi-Set Uncuffed Endotracheal Tube and Stylet Sets (REF 506550) distributed nationwide in the United States and Puerto Rico. These medical devices are used for airway management during intubation procedures in healthcare settings.

Reports indicate that the 15mm connector may disconnect from the endotracheal tube. This disconnection could compromise the secure connection between the tube and ventilation equipment during patient care.

Healthcare facilities that received these products should identify and discontinue use of affected units. Contact Teleflex LLC for information regarding device replacement, return, or proper disposal.

The recalled product

Product
Flexi-Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 506550
Manufacturer
TELEFLEX LLC
Category
Medical Device — Airway Management
Hazard
Affected units
10,600

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 4026704547715
  • Batch Numbers: 18FG01
  • 18FG05
  • 18FG13
  • 18GG17
  • 18GG31
  • 18HG12
  • 18HG19
  • 18JG21
  • 18JG32
  • 18KG41
  • 18LG18
  • 18LG28
  • 19AG21
  • 19DT25
  • 19DT33
  • 19ET54
  • 19ET77
  • 19FT24
  • 19GT59

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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