The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-1928-2023·Announced 2023-07-05

Endotracheal Tubes with Risk of Connector Disconnection Recalled

Teleflex is recalling 3,370 endotracheal tubes nationwide after reports of disconnection of the 15mm connector. Disconnection during use could interrupt airway access.

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 classification establishes a minimum severity score of 4. No illnesses or deaths are reported; however, connector disconnection from an airway management device poses direct risk of serious patient harm.

Plain-English summary

Teleflex LLC is recalling 3,370 endotracheal tubes (oral/nasal uncuffed/plain - Magill, REF 100380040) due to reports of disconnection of the 15mm connector. The affected product was distributed nationwide, including Puerto Rico, and is designated FDA Class I.

Endotracheal tubes manage airways in anesthesia, emergency, and intensive care settings. Disconnection of the 15mm connector—the interface to ventilation equipment—could compromise airway access.

Affected units are identified by batch numbers 19FT28, 19GT04, 19GT51, 19KT13, 19LT28, 20BG15, 20ET03, and batch numbers starting with KME. All affected units carry the UDI/DI designation 14026704340641.

The recalled product

Product
Endotracheal Tube oral/nasal uncuffed/plain - Magill, REF 100380040
Manufacturer
TELEFLEX LLC
Category
Medical Device — Airway Management
Hazard
Affected units
3,370

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 (19)

  • UDI/DI 14026704340641
  • Batch Numbers: 19FT28
  • 19GT04
  • 19GT51
  • 19KT13
  • 19LT28
  • 20BG15
  • 20ET03
  • KME20H2609
  • KME20J3088
  • KME20K2749
  • KME20L0640
  • KME20M1726
  • KME20M2538
  • KME21A0858
  • KME21M2918
  • KME22B2857
  • KME22C3373
  • KME22D0876

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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