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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 347,422 Preformed AGT Oral Endotracheal Tubes due to reports of 15mm connector disconnection. The connector may separate from the tube during use.
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 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.
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 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 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 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 recalled nationwide due to reported disconnection of the 15mm connector. The recall affects 1,750 units distributed across the US and Puerto Rico.
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 5,600 endotracheal tubes nationwide due to reports of 15mm connector disconnection that could compromise airway management during patient care.
Teleflex is recalling approximately 2,550 Slick Set Uncuffed Endotracheal Tubes (REF 150020) due to reports of 15mm connector disconnection.
TELEFLEX LLC recalls Flexi-Set Uncuffed Endotracheal Tube and Stylet Sets due to reports of the 15mm connector disconnecting from the tube. Approximately 16,400 units distributed nationwide are affected.
Teleflex is recalling Slick Set Uncuffed Endotracheal Tubes due to reported 15mm connector disconnection. The recall affects 22,400 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 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.
Teleflex is recalling Slick Set Cuffed Endotracheal Tube and Stylet Sets due to reports of disconnection of the 15mm connector from the endotracheal tube. The affected units were distributed nationwide.
TELEFLEX LLC is recalling 1,280 endotracheal tubes due to reports of 15mm connector disconnection. The defect could compromise airway management and poses serious safety risks during medical procedures.
TELEFLEX is recalling 2,874 Preformed AGT Oral Endotracheal Tubes nationwide due to reports of the 15mm connector disconnecting from the tube. Affected users should immediately discontinue use.
Teleflex LLC recalls 14,780 preformed AGT oral endotracheal tubes due to reports of 15mm connector disconnection. Units were distributed nationwide.
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.
Teleflex is recalling endotracheal tubes due to reports of disconnection between the tube and its 15mm connector. Affected devices were distributed nationwide including Puerto Rico.
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 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 17,102 Endotracheal Tubes (REF 100382040) following reports of disconnection of the 15mm connector from the tube. The affected units were distributed nationwide, including Puerto Rico.
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