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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 Flexi-Set Cuffed Endotracheal Tubes due to reports of 15mm connector disconnection. The recall affects 66,310 units distributed nationwide.
TELEFLEX LLC recalls RUSCHELIT Safety Clear Tracheal Tubes due to reports of 15mm connector disconnection. The Class I recall affects 30,391 units distributed nationwide including Puerto Rico.
Teleflex is recalling approximately 10,600 Flexi-Set Uncuffed Endotracheal Tube and Stylet Sets due to reports that the 15mm connector may disconnect from the tube during use.
Teleflex is recalling 347,422 Preformed AGT Oral Endotracheal Tubes due to reports of 15mm connector disconnection. The connector may separate from the tube during use.
Teleflex is recalling 3,309 Preformed AGT Oral Endotracheal Tubes due to reports of 15mm connector disconnection. This defect may compromise airway management during medical use.
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 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 endotracheal tubes due to reports of 15mm connector disconnection. The FDA Class I recall affects approximately 30,423 units distributed nationwide.
Teleflex is recalling 12,852 units of Preformed AGT Oral Endotracheal Tubes due to reports of 15mm connector disconnection from the tube. Affected units were distributed nationwide including Puerto Rico.
Teleflex LLC recalls 14,780 preformed AGT oral endotracheal tubes due to reports of 15mm connector disconnection. Units were distributed nationwide.
TELEFLEX is recalling approximately 43,571 units of Preformed AGT Oral Endotracheal Tubes due to reports of 15mm connector disconnection from the tube, affecting nationwide distribution including Puerto Rico.
TELEFLEX endotracheal tubes are being recalled due to reports of the 15mm connector disconnecting from the tube. The recall affects 860,472 units distributed nationwide, including Puerto Rico.
Teleflex is recalling 3,370 endotracheal tubes nationwide after reports of disconnection of the 15mm connector. Disconnection during use could interrupt airway access.
TELEFLEX LLC is recalling Slick Set Cuffed Endotracheal Tube and Stylet Sets due to reports of the 15mm connector disconnecting from the tube. Approximately 4,370 units distributed nationwide including Puerto Rico are affected.
Teleflex LLC is recalling Slick Set Endotracheal Tube Sets for reports of 15mm connector disconnection. The connector may separate from the tube, affecting respiratory support in patients.
TELEFLEX is recalling 3,310 units of Slick Set Uncuffed Endotracheal Tubes (REF 170155) distributed nationwide due to reports of the 15mm connector disconnecting from the tube.
Teleflex is recalling endotracheal tubes due to reports of disconnection between the tube and its 15mm connector. Affected devices were distributed nationwide including Puerto Rico.
TELEFLEX is recalling 4,160 endotracheal tubes due to reports of the 15mm connector disconnecting from the tube. Affected units were distributed 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.
Teleflex is recalling 32,553 units of Flexi-Set Uncuffed Endotracheal Tubes nationwide due to reports of 15mm connector disconnections that could compromise airway management.
TELEFLEX LLC is recalling Flexi-Set Cuffed Endotracheal Tube and Stylet Sets nationwide due to reports of the 15mm connector disconnecting from the tube, posing a serious risk in critical care settings.
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 1,110 endotracheal tubes due to reports of 15mm connector disconnection. The affected units are distributed nationwide in the US and Puerto Rico.
Teleflex is recalling Slick Set Uncuffed Endotracheal Tubes nationwide due to reported disconnection of the 15mm connector from the tube. This disconnection could result in loss of airway during patient care.
TELEFLEX LLC recalls Flexi-Set Uncuffed Endotracheal Tube and Stylet Sets due to reports of the 15mm connector disconnecting from the tube. Approximately 16,400 units distributed nationwide are affected.
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