The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-1887-2023·Announced 2023-07-05

Endotracheal Tube Connectors May Disconnect - Teleflex Recall

Teleflex endotracheal tubes with specific batch numbers may experience disconnection of the 15mm connector during clinical use. The FDA has classified this as a Class I recall affecting 247,645 units distributed nationwide.

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: This is an FDA Class I recall of a critical airway management device. Although no deaths or serious injuries are reported in the source text, FDA Class I classification requires a minimum severity score of 4. The potential for connector disconnection during use poses significant risk to patient airway and ventilation.

Plain-English summary

This recall affects Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff (REF 112082065), manufactured by Teleflex LLC. The product is used for airway management in patients requiring endotracheal intubation.

The FDA has received reports of the 15mm connector disconnecting from the endotracheal tube during use. A disconnected connector could result in loss of airway access and compromise patient ventilation during intubation or mechanical ventilation.

This recall affects 247,645 units distributed nationwide, including Puerto Rico. The affected units are identified by UDI/DI 14026704341419 and specific batch numbers ranging from 18FG23 through KME22H2054.

Healthcare facilities and providers using these tubes should immediately identify and quarantine affected units by batch number and contact Teleflex LLC or the FDA for instructions on product replacement or return.

The recalled product

Product
Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082065
Manufacturer
TELEFLEX LLC
Category
Medical Device — Airway Management
Hazard
Affected units
247,645

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 14026704341419
  • Batch Numbers: 18FG23
  • 18FG27
  • 18FG30
  • 18FG31
  • 18FT06
  • 18FT08
  • 18GG19
  • 18GT32
  • 18GT34
  • 18HG02
  • 18HG15
  • 18IG02
  • 18IG07
  • 18IG13
  • 18IT25
  • 18JG01
  • 18JG02
  • 18JG04
  • 18JG07

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

See all →

Same hazard · connector disconnection

See all →

Similar recalls