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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 1,570 units of Preformed AGT Oral Endotracheal Tubes nationwide due to reports of 15mm connector disconnection from the tubes. The disconnection could compromise airway management during patient ventilation.
Teleflex is recalling 4,769 endotracheal tubes due to reports of 15mm connector disconnection. This defect could interrupt breathing support during airway management procedures.
Teleflex LLC is recalling approximately 15,810 Preformed AGT Oral Endotracheal Tubes due to reports of 15mm connector disconnection. The affected units were distributed nationwide, including Puerto Rico.
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 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 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 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 LLC is recalling RUSCHELIT Safety Clear Tracheal Tubes due to reports of 15mm connector disconnection. The recall involves 21,284 units 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 LLC is recalling 2,140 endotracheal tubes nationwide due to reports of the 15mm connector disconnecting from the tube. Affected units were distributed throughout the United States, including Puerto Rico.
Teleflex has recalled 49,050 endotracheal tubes due to reported disconnection of the 15mm connector. Affected units were distributed nationwide, including Puerto Rico.
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 Preformed AGT Oral Endotracheal Tubes due to reported connector disconnections. The recall affects 24,752 units distributed nationwide, including Puerto Rico.
TELEFLEX LLC is recalling Preformed AGT Oral Endotracheal Tubes because the 15mm connector may disconnect from the tube, creating a potential airway access risk.
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 37,890 Preformed AGT endotracheal tubes due to reports of 15mm connector disconnection. The devices were distributed nationwide in the United States and Puerto Rico.
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 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 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 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 25,630 endotracheal tubes nationwide because the 15mm connector can disconnect. The affected products were distributed throughout the United States and Puerto Rico.
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 2,382 Slick Set Uncuffed Endotracheal Tubes due to reports of 15mm connector disconnection. Units were distributed nationwide including 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 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.
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