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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 LLC is recalling 170,179 endotracheal tubes nationwide due to reports of 15mm connector disconnection. The tubes are used for airway management in medical facilities.
Flexi-Set Cuffed Endotracheal Tube kits are being recalled due to reports of the 15mm connector disconnecting from the tube. Affected units were distributed nationwide.
TELEFLEX LLC is recalling 300,613 endotracheal tubes due to reports of 15mm connector disconnection. The affected tubes were distributed nationwide and could pose patient safety risks.
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 16,570 units of Preformed AGT Oral Endotracheal Tubes due to reports of 15mm connector disconnection, which could compromise airway management during use.
Teleflex LLC is recalling 1,670 Magill endotracheal tubes (REF 100380055) due to reports of 15mm connector disconnection. The Class I recall affects units distributed nationwide in the US and Puerto Rico.
Teleflex is recalling RUSCHELIT Safety Clear Tracheal Tubes due to reports of 15mm connector disconnection. The affected tubes are distributed nationwide.
Megadyne Medical Products recalls approximately 21,100 MEGADYNE MEGA SOFT Pediatric Patient Return Electrodes (Model 0840) due to reports of patient burns during electrosurgical procedures.
TELEFLEX LLC is recalling 9,070 Preformed AGT Oral Endotracheal Tubes nationwide due to reports of 15mm connector disconnection. This medical device is used for airway management in hospital settings.
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 244,120 Flexi-Set Cuffed Endotracheal Tubes due to reports that the 15mm connector may disconnect from the tube. Affected units were distributed nationwide.
Teleflex is recalling 18,900 Slick Set Uncuffed Endotracheal Tubes due to reports of 15mm connector disconnection. The affected units were distributed nationwide in the United States and Puerto Rico.
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 LLC is recalling Preformed AGT Oral Endotracheal Tubes due to reported connector disconnections. The recall affects 24,752 units distributed nationwide, including Puerto Rico.
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 endotracheal tubes with high-volume, low-pressure cuffs are recalled due to reports of 15mm connector disconnection. The recall affects 13,810 units distributed nationwide.
TELEFLEX LLC is recalling RUSCHELIT Safety Clear Tracheal Tubes due to reports of 15mm connector disconnection. The recall involves 21,284 units 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 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 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 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 approximately 170,610 endotracheal tubes due to reports of 15mm connector disconnection. The disconnection could compromise airway management during mechanical ventilation.
Teleflex is recalling 670 units of Preformed AGT Oral Endotracheal Tubes nationwide due to reports of 15mm connector disconnection from the tube.
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 is recalling 4,146 preformed endotracheal tubes due to reports of 15mm connector disconnection. The affected devices were distributed nationwide.
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