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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 12,400 Flexi-Set Uncuffed Endotracheal Tube and Stylet Sets nationwide due to reports of 15mm connector disconnection. The affected batches and lot numbers are identified above.
Teleflex is recalling Slick Set Uncuffed Endotracheal Tubes due to reports of the 15mm connector disconnecting from the tube. The recall affects 14,160 units distributed nationwide.
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 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 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 4,160 endotracheal tubes due to reports of the 15mm connector disconnecting from the tube. Affected units were 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 is recalling 47,520 endotracheal tubes due to reported 15mm connector disconnection. The FDA classified this as a Class I recall; disconnected tubes could compromise airway management.
Teleflex is recalling 4,146 preformed endotracheal tubes due to reports of 15mm connector disconnection. The affected devices were distributed nationwide.
Teleflex is recalling 20,042 endotracheal tubes due to reports of 15mm connector disconnection that could compromise airway management. The FDA classified this as a Class I recall.
The FDA is recalling approximately 302,652 Teleflex preformed oral endotracheal tubes nationwide due to reports of disconnection between the 15mm connector and the tube. Healthcare providers should immediately discontinue use of affected units.
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 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 is recalling Slick Set Cuffed Endotracheal Tubes because the 15mm connector may disconnect from the tube. The recall affects 1,460 units distributed nationwide, including 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 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 LLC is recalling 3,031 Endotracheal Tube units due to reports of 15mm connector disconnection. The affected Magill model (REF 100380045) was 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 recalls 53,216 Preformed AGT Endotracheal Tubes due to reported disconnection of the 15mm connector. Affected units were distributed nationwide including Puerto Rico.
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 endotracheal tubes are being recalled due to potential disconnection of the 15mm connector from the breathing tube. The disconnection could compromise respiratory support in patients.
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 32,553 units of Flexi-Set Uncuffed Endotracheal Tubes nationwide due to reports of 15mm connector disconnections that could compromise airway management.
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 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.
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