The Recall Desk
SevereFDA (Devices)·Z-1958-2023·Announced 2023-07-05

Teleflex Endotracheal Tubes Recalled Due to Connector Disconnection Risk

Teleflex endotracheal tubes are recalled nationwide due to reported disconnection of the 15mm connector. The recall affects 1,750 units distributed across the US and Puerto Rico.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: FDA Class I classification mandates a minimum severity of 4. The defect—15mm connector disconnection on a critical airway management device—constitutes a structural medical device failure with potential for serious patient harm, meeting the Severe criteria.

Plain-English summary

Teleflex LLC is recalling endotracheal tubes with a High Volume, Low Pressure Cuff design (Model REF 112080050). The recall involves 1,750 units distributed nationwide, including Puerto Rico.

Reports have been received of disconnection of the 15mm connector from the endotracheal tube. This disconnection could compromise airway management during medical procedures and patient care.

Healthcare facilities and providers using affected batch numbers should discontinue use of these devices immediately. Affected batch numbers include: 18FG07, 18JG33, 18JG36, 18LT16, 19CT26, 19KT38, 19LT07, 20AT41, 20CT13, 20ET17, KME20K1512, KME22B0593, KME22E2347, KME22H1178, KME22H3021. Contact Teleflex LLC or the FDA for information about replacements or corrective actions.

The recalled product

Product
Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080050
Manufacturer
TELEFLEX LLC
Category
Medical Device — Airway Management
Hazard
Affected units
1,750

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 (16)

  • UDI/DI 14026704341266
  • Batch Numbers: 18FG07
  • 18JG33
  • 18JG36
  • 18LT16
  • 19CT26
  • 19KT38
  • 19LT07
  • 20AT41
  • 20CT13
  • 20ET17
  • KME20K1512
  • KME22B0593
  • KME22E2347
  • KME22H1178
  • KME22H3021

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

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Same hazard · connector disconnection

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