The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-1925-2023·Announced 2023-07-05

Endotracheal Tube Connector Disconnection Reported by Teleflex

Teleflex is recalling endotracheal tubes due to reports of disconnection between the tube and its 15mm connector. Affected devices were distributed nationwide including Puerto Rico.

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, which establishes a minimum severity floor of 4 per the rubric rules. While the source text does not report actual injuries or deaths, the device failure (connector disconnection) involves a critical airway management device where malfunction could result in serious patient harm.

Plain-English summary

Teleflex LLC is recalling 3,590 endotracheal tubes (ETT) (oral/nasal uncuffed/plain - Magill, model REF 100380025) due to reports of disconnection between the tube and its 15mm connector.

The affected tubes were distributed nationwide in the United States, including Puerto Rico. The recalled batch numbers include: 19ET51, 19FT29, 19GT05, 19GT35, 19HT79, 19JT51, 19KT06, 19LT28, 20AT05, 20AT37, 20AT54, 20BG15, 20DT24, 20ET03, KME21B0529, KME21C0887, KME21D0327, KME21F0137, KME21K0799, KME21K0800, KME22A2704, KME22C0981, KME22C1568, KME22D0029, KME22H0686, KME22H1360. The product UDI/DI is 14026704340610.

Healthcare facilities and providers should immediately discontinue use of affected devices and consult with Teleflex or their medical device distributor with questions about this recall.

The recalled product

Product
Endotracheal Tube oral/nasal uncuffed/plain - Magill, REF 100380025
Manufacturer
TELEFLEX LLC
Category
Medical Device — Respiratory / Airway
Hazard
Affected units
3,590

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 14026704340610
  • Batch Numbers: 19ET51
  • 19FT29
  • 19GT05
  • 19GT35
  • 19HT79
  • 19JT51
  • 19KT06
  • 19LT28
  • 20AT05
  • 20AT37
  • 20AT54
  • 20BG15
  • 20DT24
  • 20ET03
  • KME21B0529
  • KME21C0887
  • KME21D0327
  • KME21F0137
  • KME21K0799

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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