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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 Slick Set Cuffed Endotracheal Tubes (REF 1700100) due to reports of the 15mm connector disconnecting from the device during use.
Teleflex is recalling Preformed AGT Oral Endotracheal Tubes due to reports that the 15mm connector may disconnect from the tube. The recall affects 5,120 units distributed nationwide.
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 approximately 25,435 endotracheal tubes (REF 100382035) distributed nationwide due to reported disconnection of the 15mm connector from the device.
TELEFLEX is recalling 17,950 endotracheal tubes due to reports of the 15mm connector disconnecting from the device. These are critical airway support devices.
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 Slick Set Uncuffed Endotracheal Tubes due to reported 15mm connector disconnection. The recall affects 22,400 units distributed nationwide.
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 17,551 units of Flexi-Set Uncuffed Endotracheal Tubes nationwide after reports of the 15mm connector disconnecting from the tube.
Teleflex is recalling 19,250 endotracheal tubes because the 15mm connector may disconnect during use, potentially compromising airway management in patients.
TELEFLEX is recalling 25,630 endotracheal tubes nationwide because the 15mm connector can disconnect. The affected products were distributed throughout the United States and Puerto Rico.
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 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 LLC is recalling 13,710 units of Flexi-Set Cuffed Endotracheal Tubes due to reports of connector disconnection. The 15mm connector may separate from the tube during use.
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 Preformed AGT Oral Endotracheal Tubes due to reports of the 15mm connector disconnecting from the tube. Approximately 2,980 units were distributed nationwide.
Megadyne Medical Products is recalling MEGA SOFT Universal Patient Return Electrodes after reports of patient burns during electrosurgery procedures. The FDA classified this as a Class I recall.
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 endotracheal tubes after reports that the 15mm connector may disconnect from the tube. The recall affects 36,135 units distributed nationwide.
Megadyne Medical Products is recalling 21,100 MEGADYNE MEGA SOFT Reusable Patient Return Electrodes nationwide due to reports of patient burns during electrosurgical procedures.
TELEFLEX is recalling Slick Set Cuffed Endotracheal Tube and Stylet Sets due to reports that the 15mm connector may disconnect from the tube during use.
Teleflex has recalled 49,050 endotracheal tubes due to reported disconnection of the 15mm connector. 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 has recalled approximately 50,000 Slick Set Endotracheal Tubes nationwide due to reports of connector disconnection.
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.
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