Category
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 Slick Set endotracheal tubes due to reports of 15mm connector disconnection. The defect could prevent proper airway management during patient care.
Teleflex is recalling 190 endotracheal tubes due to reports of the 15mm connector disconnecting from the tube. This disconnection could compromise airway management and ventilation.
TELEFLEX is recalling approximately 8,620 Preformed AGT Oral Endotracheal Tubes distributed nationwide due to reports of disconnection of the 15mm connector from the tube.
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 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 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 Flexi-Set Cuffed Endotracheal Tubes due to reports of 15mm connector disconnection. The recall affects 66,310 units distributed nationwide.
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.
Teleflex is recalling 31,945 RUSCHELIT Safety Clear Tracheal Tubes nationwide due to reports of 15mm connector disconnection from the endotracheal tube.
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 6,710 endotracheal tubes due to reports of 15mm connector disconnection. This Class I recall affects units distributed nationwide.
DRE Medical Group recalled 22 Philips Respironics V60 ventilators due to potential contamination in the gas pathway of retrofitted units. These devices may pose a serious health risk to patients.
Waldemar Link is recalling 22 units of the LINK Endo-Model Modular Knee Prosthesis System Femoral Segment, Size 3, Left, because device segments may not meet specifications. The company discovered the issue through customer complaints.
Baxter Healthcare is recalling NaviCare Patient Safety software for Centrella Bed. A software defect may prevent caregiver alerts for patient bed exits and positioning changes.
B. Braun Medical recalled 16,070 Perifix epidural anesthesia kits that were assembled with an incorrect filter straw. The kits were distributed nationwide.
Luminex Corporation recalls Verigene nucleic acid test kits that may rarely produce false-negative results due to hydrophobic properties in certain FLOQSwab lots. False-negative results could fail to detect enteric pathogens in patient samples.
Remel is recalling specific lot numbers of Haemophilus Test Medium (Agar) because the test medium may not perform as intended. This diagnostic device is used in laboratory testing nationwide.
Ellex Medical is recalling certain Integre Pro laser ophthalmoscope systems because scattered laser radiation may unintentionally exit the device and be emitted from the objective lens, potentially exposing users' eyes to unexpected laser energy.
Exactech is recalling 250 units of its Shoulder GPS Impactor Handle due to a defect where the ball and spring in the locking mechanism can dislodge during disassembly or impaction. The defect could affect the device's function during surgical use.
RaySearch America is recalling RayStation radiation therapy treatment planning software due to a software bug that produces incorrect dose calculations. The error could lead to inappropriate treatment plans being approved for patient use.
Limacorporate is recalling Prima TT Genoid Monoblock Reverse TT Baseplates due to a manufacturing issue that may result in peripheral holes being out of specification.
AEQUALIS FLEX REVIVE assembly screws were mislabeled during manufacturing, with some units marked as 0mm Standard actually being 0mm Short and vice versa. Surgeons must verify model numbers before use.
Permobil's PushTracker E2 watch controls wheelchair power assist motors. The application may crash when running multiple processes, causing the motor to keep running and preventing users from stopping it using normal controls.
A software defect in the PushTracker E3 watch can cause the SmartDrive motor to run uncontrollably, and users may not be able to stop the device using tap controls. Approximately 6,196 units worldwide are affected.
Exactech Ergo Impactor Handles are recalled because the ball and spring in the locking mechanism may dislodge during disassembly or use. Approximately 784 devices are affected.
Looking for a different category? Browse all recalls.