FDA (Devices) recall action 92373
The FDA (Devices) publishes a recall like this one as 123 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 123 pages.
Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
TELEFLEX LLC is recalling 3,100 preformed oral endotracheal tubes nationwide due to reports of 15mm connector disconnection that could compromise airway management.
Teleflex is recalling RUSCHELIT Safety Clear Tracheal Tubes due to reports of 15mm connector disconnection. The affected tubes are distributed nationwide.
Teleflex LLC is recalling 17,840 Preformed AGT Oral Endotracheal Tubes due to reports of 15mm connector disconnection. These tubes have been distributed nationwide including Puerto Rico.
TELEFLEX LLC is recalling 690 endotracheal tubes with high-volume, low-pressure cuff due to reports of connector disconnection. The affected products were distributed nationwide.
TELEFLEX LLC is recalling Flexi-Set Cuffed Endotracheal Tube and Stylet Sets nationwide due to reports of connector disconnection. The affected devices may disconnect during use, potentially compromising airway management.
Teleflex is recalling Flexi-Set Cuffed Endotracheal Tubes due to reports of 15mm connector disconnection. The recall affects 66,310 units distributed nationwide.
Teleflex is recalling Slick Set Cuffed Endotracheal Tubes due to reports of the 15mm connector disconnecting from the tube, which could interrupt airway support during mechanical ventilation.
Teleflex LLC is recalling 670 endotracheal tubes due to reports that the 15mm connector is disconnecting from the tube. Affected units were distributed nationwide including Puerto Rico.
Teleflex LLC is recalling 2,860 endotracheal tubes due to reports of 15mm connector disconnection. Affected tubes were distributed nationwide including Puerto Rico.
Teleflex is recalling Slick Set Uncuffed Endotracheal Tube kits due to reports of 15mm connector disconnection. 20,662 units have been distributed nationwide, including Puerto Rico.
Teleflex recalls 76,060 preformed oral endotracheal tubes due to reports of 15mm connector disconnection. A disconnected connector could compromise ventilation in critical care settings.
Teleflex is recalling 190 endotracheal tubes due to reports of the 15mm connector disconnecting from the tube. This disconnection could compromise airway management and ventilation.
Teleflex recalled 720 units of its Slick Set Cuffed Endotracheal Tube and Stylet Set due to reports of connector disconnection. The recall affects units distributed nationwide including Puerto Rico.
Teleflex is recalling 17,551 units of Flexi-Set Uncuffed Endotracheal Tubes nationwide after reports of the 15mm connector disconnecting from the tube.
TELEFLEX is recalling approximately 25,435 endotracheal tubes (REF 100382035) distributed nationwide due to reported disconnection of the 15mm connector from the device.
Teleflex is recalling approximately 2,550 Slick Set Uncuffed Endotracheal Tubes (REF 150020) due to reports of 15mm connector disconnection.
Teleflex LLC is recalling 7,800 endotracheal tubes due to reports of the 15mm connector disconnecting from the tube. The affected products were distributed nationwide in the US and Puerto Rico.
Teleflex is recalling 31,945 RUSCHELIT Safety Clear Tracheal Tubes nationwide due to reports of 15mm connector disconnection from the endotracheal tube.
Teleflex is recalling 8,610 Preformed AGT Oral Endotracheal Tubes nationwide due to reports that the 15mm connector can disconnect from the tube.
TELEFLEX is recalling RUSCHELIT Safety Clear Tracheal Tubes due to reported disconnection of the 15mm connector, affecting approximately 37,076 units distributed nationwide.
Teleflex is recalling 670 units of Preformed AGT Oral Endotracheal Tubes nationwide due to reports of 15mm connector disconnection from the tube.
Teleflex LLC is recalling 19,842 preformed oral endotracheal tubes due to reports of 15mm connector disconnection. Affected devices were distributed nationwide.
TELEFLEX LLC is recalling 6,710 endotracheal tubes due to reports of 15mm connector disconnection. This Class I recall affects units distributed nationwide.
TELEFLEX is recalling 760 endotracheal tubes due to reports of 15mm connector disconnection. This medical device failure could compromise airway management during critical care.
Teleflex endotracheal tubes with specific batch numbers may experience disconnection of the 15mm connector during clinical use. The FDA has classified this as a Class I recall affecting 247,645 units distributed nationwide.