FDA•MODERATE
Gentherm Thermal Regulating System
Gentherm recalls thermal regulating systems over CPU board overheating that may cause shutdown.
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Medical Devices Recalls
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FDA•MODERATEKidneyVault Portable Renal Perfusion SystemParagonix recalls KidneyVault perfusion system over firmware defect causing blank screen.
FDA•MODERATESiemens Healthineers Immulite 2000 SYP Syphilis ScreenSiemens Healthineers recalls Immulite 2000 SYP Syphilis Screen due to negative bias risk.
2 products
FDA•MODERATEHalyard LAVH Pack Clearify Visualization SystemAVID Medical recalls Halyard LAVH Pack (USAR053-11) due to possible leakage of the Clearify Visualization System.
2 products
FDA•MODERATEGetinge SERVO-U/SERVO-N Y Sensor ModuleGetinge recalls SERVO-U/N Y sensor module over missing safety electrical testing.
2 products
FDA•MODERATEOverStitch Suture CinchBoston Scientific recalls OverStitch Suture Cinch over deployment and suture-cutting failures.
2 products
FDA•MODERATETD Navio Midi Speech Generating DeviceTobii Dynavox recalls TD Navio Midi speech device over battery tab damage risk.
2 products
FDA•MODERATEArrow-LOK ImplantArrowhead recalls Arrow-LOK Implants over missing gamma radiation audit, risking infection.
2 products- Device RecallFDA•MODERATEARVIS Surgical Navigation System Gen 2
Kico Knee recalls ARVIS Surgical Navigation System Gen 2 over tilted eyepiece image from sensor issue.
2 products 
FDA•MODERATEPhilips Cardiac Workstation 5000Philips recalls Cardiac Workstation 5000 over intermittent inaccurate heart-rate data.
2 products
FDA•MODERATEDentsply Sirona Capsule MixerDentsply Sirona Capsule Mixer recalled over electrical discharge risk when unplugged.
FDA•MODERATEIntersurgical One-Piece Guedel AirwayIntersurgical recalls One-Piece Guedel Airway, size 00, ISO 5.0, Blue, due to potential occlusion.
2 products- Device RecallFDA•MODERATEHamilton Microlab STAR PCT Software
Foundation Medicine recalls Hamilton Microlab STAR PCT v2.0.0 over spontaneous software closures.
FDA•MODERATEEndoFLIP 1 SystemCovidien recalls EndoFLIP 1 System due to 24-hour limit flagging products as expired.
2 products
FDA•MODERATEPresource KitsCardinal Health is recalling multiple Presource procedural kits due to possible endotoxin contamination.
13 products
FDA•MODERATEBD Intravascular Administration and Extension SetsBD recalls IV administration and extension sets due to possible sterilization failure.
2 products