FDA•MODERATE
APTUS 2.5 TriLock Screw 16mm
Medartis is recalling APTUS 2.5 TriLock Screw 16mm (Model A-5750.16/1) due to a packaging mix-up with 2.8mm screws.
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Medical Devices Recalls
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FDA•MODERATEMaquet Venous Bubble SensorMaquet is recalling Venous Bubble Sensors for 3/8" x 3/32" tubing due to cable durability issues that may cause sensor failure.
FDA•MODERATEFDR Visionary Suite X-ray GeneratorFDR Visionary Suite X-ray generators are being recalled due to a risk of overheating and smoke caused by faulty electromagnetic contactors.
FDA•MODERATEDiowave 250W Laser SystemDiowave 250W Laser System recalled; software update needed to correct power output exceeding FDA-cleared 60W limit.
FDA•MODERATEMedline Dialysis Insertion KitsMedline is recalling dialysis insertion kits due to defective Tego Connector silicone seals that may cause leakage or therapy interruption.
6 products
FDA•MODERATEOlympus ShockPulse-SE Lithotripsy System GeneratorOlympus is recalling ShockPulse-SE Lithotripsy System generators due to a mis-wired component that may cause treatment delays.
2 products
FDA•MODERATEOlympus Single Use 3-Lumen Sphincterotome VOlympus is recalling the Single Use 3-Lumen Sphincterotome V (Model KD-V411M-1520) due to a manufacturing defect that may cause device deformation.
30 products
FDA•MODERATEMedline Surgical Convenience KitsMedline is recalling various surgical convenience kits due to potential issues with sterilization and packaging calibration.
62 products
FDA•MODERATEPhilips Brilliance iCT and Spectral CT 7500 Gantry RotorPhilips is recalling Brilliance iCT and Spectral CT 7500 systems because improperly torqued gantry fasteners may cause rotor parts to detach.
4 products- Device RecallFDA•MODERATEMint Lesion Software
Mint Medical is recalling Mint Lesion software versions 3.4.0–3.9.5 due to a risk of data loss or incorrect patient record linking.
FDA•MODERATEMedline Convenience KitsMedline is recalling convenience kits due to potential sterility issues caused by equipment calibration errors.
58 products
FDA•MODERATEPrismaflex M100 SetVantive is recalling the Prismaflex M100 Set due to a potential deaeration chamber dislodgement risk.
8 products
FDA•MODERATEVITEK 2 Gram-negative Susceptibility CardsBioMérieux is recalling 30+ VITEK 2 susceptibility card variants over risks of quality control failures and false resistant test results.
2 products
FDA•MODERATERaz Mobile Shower Commode ChairsRaz Design is recalling various mobile shower commode chairs due to a seat bracket installation issue that may cause seat instability.
2 products
FDA•MODERATEMedline Nail KitMedline is recalling the Nail Kit (Model DYKM1528) due to a potential sterility assurance issue with the included wound wash.
5 products
FDA•MODERATEEMPOWR Acetabular System and Knee Tibial InsertsEncore Medical is recalling EMPOWR acetabular liners and knee inserts due to a packaging discrepancy that may cause surgical delays.
2 products
FDA•MODERATEHalyard Transport Bag Kit LIFE0080-01Halyard Transport Bag Kit LIFE0080-01 recalled due to Tyvek bag seal issue that may compromise sterility.
FDA•MODERATEATEC Lateral Navigation Disc Prep InstrumentsAlphatec Spine is recalling ATEC Lateral Navigation Disc Prep Instruments due to a design issue with the navigated array connection geometry.
2 products