Category
FDA recalls of medical devices including diagnostics, implants, and consumer health hardware.
Medical device recalls are the FDA's highest-volume stream. They cover implantable devices like pacemakers and joint replacements, hospital diagnostics and lab analyzers, surgical instruments, software-as-a-medical-device, and consumer-facing hardware like CPAP machines, blood-pressure cuffs, and glucose monitors. The volume comes from the wide range of products in scope and from the FDA's broad definition of 'corrective action' — software updates, IFU revisions, and labeling corrections all show up as recalls.
For Class I device recalls, the device's defect creates a reasonable risk of serious injury or death — these are the urgent ones. Class II covers issues that may cause temporary or medically reversible harm, often around accuracy or calibration. Class III is for products that don't comply with FDA rules but pose no real safety risk; in practice many software-update letters are Class III.
If you depend on a recalled device for ongoing care, don't disconnect or stop using it before talking to the prescribing clinician — interrupting therapy for a CPAP or a continuous glucose monitor can be more dangerous than the recall it's responding to. Almost every device recall offers a remedy that doesn't require you to surrender the device first.
Teleflex is recalling approximately 446,163 Preformed AGT Oral Endotracheal Tubes due to reports of 15mm connector disconnection. The connector failure could affect tube function during patient airway management.
TELEFLEX is recalling 16,570 units of Preformed AGT Oral Endotracheal Tubes due to reports of 15mm connector disconnection, which could compromise airway management during use.
Teleflex is recalling Slick Set Uncuffed Endotracheal Tube and Stylet Sets due to reports that the 15mm connector may disconnect from the tube. The recall affects 447 units distributed nationwide.
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 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 Slick Set Cuffed Endotracheal Tubes nationwide due to reported disconnection of the 15mm connector from the tube, affecting airway management in critical care settings.
TELEFLEX is recalling Preformed AGT Oral Endotracheal Tubes due to reports of the 15mm connector disconnecting from the tube. The affected product has been distributed nationwide.
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 4,160 endotracheal tubes due to reports of the 15mm connector disconnecting from the tube. Affected units were distributed nationwide.
TELEFLEX LLC recalls 2,520 endotracheal tubes (model REF 112080055) due to reports of 15mm connector disconnection. The disconnection could compromise airway function during critical care use.
Teleflex is recalling approximately 39,550 endotracheal tubes due to reports of 15mm connector disconnection. The FDA Class I recall affects units distributed nationwide including Puerto Rico.
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.
Teleflex is recalling approximately 2,550 Slick Set Uncuffed Endotracheal Tubes (REF 150020) due to reports of 15mm connector disconnection.
TELEFLEX LLC is recalling Flexi-Set Cuffed Endotracheal Tube and Stylet Sets due to reports of 15mm connector disconnection. Approximately 684,042 units were distributed nationwide, including Puerto Rico.
Teleflex endotracheal tubes are being recalled due to reports of 15mm connector disconnection. The recall affects approximately 4,110 units distributed nationwide.
Teleflex is recalling over 1 million Flexi-Set Cuffed Endotracheal Tube kits due to reports of 15mm connector disconnection from the tube. The recall affects products distributed nationwide.
TELEFLEX is recalling approximately 25,435 endotracheal tubes (REF 100382035) distributed nationwide due to reported disconnection of the 15mm connector from the device.
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 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 Slick Set Uncuffed Endotracheal Tube kits due to reports of 15mm connector disconnection. 20,662 units have been distributed nationwide, including Puerto Rico.
Teleflex is recalling 18,353 Flexi-Set Uncuffed Endotracheal Tube sets nationwide due to reports of 15mm connector disconnection. The defect could affect ventilation during use.
Teleflex is recalling endotracheal tubes after reports that the 15mm connector may disconnect from the tube. The recall affects 36,135 units distributed nationwide.
Teleflex LLC is recalling 11,188 endotracheal tubes due to reports of 15mm connector disconnection. The defect affects this critical airway management device nationwide.
Teleflex is recalling Flexi-Set Cuffed Endotracheal Tube Sets due to reported 15mm connector disconnection. The recall affects 92,930 units distributed throughout the United States, including Puerto Rico.
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