The Recall Desk
Agency classClass IOur severity:CriticalFDA (Devices)·Z-1927-2023·Announced 2023-07-05

Endotracheal Tubes Recalled for Connector Disconnection Risk

Teleflex LLC is recalling 2,860 endotracheal tubes due to reports of 15mm connector disconnection. Affected tubes 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 5/5 (Critical).

Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.

Our severity reasoning: FDA Class I medical device recall. FDA Class I classifications are used for products with reasonable probability of causing serious adverse health consequences or death.

Plain-English summary

Teleflex LLC is recalling Endotracheal Tube oral/nasal uncuffed/plain - Magill, REF 100380035, due to reports of connector disconnection. A total of 2,860 units are affected, bearing UDI/DI 14026704340634 across multiple batch numbers including 18HG08, 18IG13, 18JG35, 18LG31, 19BG15, 19CT16, 19ET31, 19HT07, 19HT79, 19LT28, 20GT37, KME20H2590, KME20L0690, KME22D0945, KME22E1145, KME22G2935, KME22J0819, and KME22J2900.

The reported issue is disconnection of the 15mm connector from the endotracheal tube. This connector failure could affect the tube's function and compromise patient care.

The affected tubes were distributed nationwide throughout the United States, including Puerto Rico. Healthcare facilities and providers using these specific products should verify their inventory against the listed batch numbers.

The recalled product

Product
Endotracheal Tube oral/nasal uncuffed/plain - Magill, REF 100380035
Manufacturer
TELEFLEX LLC
Category
Medical Device
Hazard
Affected units
2,860

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 14026704340634
  • Batch Numbers: 18HG08
  • 18IG13
  • 18JG35
  • 18LG31
  • 19BG15
  • 19CT16
  • 19ET31
  • 19HT07
  • 19HT79
  • 19LT28
  • 20GT37
  • KME20H2590
  • KME20L0690
  • KME22D0945
  • KME22E1145
  • KME22G2935
  • KME22J0819
  • KME22J2900

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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