The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-1938-2023·Announced 2023-07-05

TELEFLEX Endotracheal Tubes Recalled for 15mm Connector Disconnection

TELEFLEX is recalling 5,600 endotracheal tubes nationwide due to reports of 15mm connector disconnection that could compromise airway management during patient care.

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 requires minimum severity of 4. Endotracheal tube connector disconnection during clinical use could compromise critical airway management. No injuries or deaths are explicitly reported in the source.

Plain-English summary

TELEFLEX LLC is recalling 5,600 endotracheal tubes (oral/nasal, uncuffed, plain - Murphy design, REF 100382060) due to reports of 15mm connector disconnection.

The recalled tubes have been distributed nationwide in the United States, including Puerto Rico. Affected batch numbers include 18FG02, 18FG28, 18FT08, 18FT33, 18JG15, 18KG23, 18KG39, 20BT17, 20CT07, KME20H1758, KME20H2730, KME21D0828, KME21J0120, KME21J1583, KME22A2339, KME22B0949, KME22B1778, KME22C2310, KME22D1804, KME22F0417, KME22F0556, and KME22F1739.

Connector disconnection during clinical use could affect airway management. Healthcare providers should immediately check their inventory for affected batch numbers and discontinue use of these tubes. Contact TELEFLEX LLC for replacement information.

The recalled product

Product
Endotracheal Tube oral/nasal uncuffed/plain - Murphy, REF 100382060
Manufacturer
TELEFLEX LLC
Category
Medical Device — Respiratory Equipment
Hazard
Affected units
5,600

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 14026704340856
  • Batch Numbers: 18FG02
  • 18FG28
  • 18FT08
  • 18FT33
  • 18JG15
  • 18KG23
  • 18KG39
  • 20BT17
  • 20CT07
  • KME20H1758
  • KME20H2730
  • KME21D0828
  • KME21J0120
  • KME21J1583
  • KME22A2339
  • KME22B0949
  • KME22B1778
  • KME22C2310
  • KME22D1804

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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