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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.
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 14,480 Preformed AGT Oral Endotracheal Tubes nationwide due to reports of 15mm connector disconnection from the tube during use.
Teleflex recalls preformed AGT oral endotracheal tubes because the 15mm connector may disconnect from the tube, posing risk during patient use.
Teleflex endotracheal tubes are recalled nationwide due to reported disconnection of the 15mm connector. The recall affects 1,750 units distributed across the US and Puerto Rico.
Teleflex is recalling 510 units of Slick Set Endotracheal Tubes with reported connector disconnection issues. The defect may prevent proper airway management during critical medical use.
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.
Megadyne Medical Products is recalling the MEGADYNE MEGA SOFT Dual Reusable Patient Return Electrode used in electrosurgery due to reports of patient burns during surgical procedures.
Teleflex is recalling Slick Set endotracheal tubes due to reports of 15mm connector disconnection. The defect could prevent proper airway management 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 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 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 LLC is recalling 19,842 preformed oral endotracheal tubes due to reports of 15mm connector disconnection. Affected devices were distributed nationwide.
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 is recalling Preformed AGT Oral Endotracheal Tubes due to reports of 15mm connector disconnection. This Class I recall affects 23,395 units distributed nationwide.
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 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 RUSCHELIT Safety Clear Tracheal Tubes due to reports of 15mm connector disconnection. The recall involves 21,284 units distributed nationwide.
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 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 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 870 units of Slick Set Uncuffed Endotracheal Tubes nationwide due to reports of disconnection of the 15mm connector from the tube.
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 has recalled approximately 50,000 Slick Set Endotracheal Tubes nationwide due to reports of connector disconnection.
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 endotracheal tubes with specific batch numbers may experience disconnection of the 15mm connector during clinical use. The FDA has classified this as a Class I recall affecting 247,645 units distributed nationwide.
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