FDA•MODERATE
nanOss 3D Advanced Bone Graft Substitute
XTANT Medical is recalling nanOss 3D bone graft substitutes due to an incorrect five-year shelf life label.
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Medical Devices Recalls
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FDA•MODERATEMilestone Vacuum Bag SU Large Specimen ContainerMilestone is recalling Vacuum Bag SU Large specimen containers (Model 68409SS) due to possible reagent leakage.
FDA•MODERATELSL Healthcare Central Line Dressing KitLSL Healthcare is recalling Central Line Dressing Kit model 2717H due to the inclusion of non-sterile alcohol prep pads.
6 products
FDA•MODERATEKiwi Omni Vacuum Delivery SystemClinical Innovations is recalling the Kiwi Omni Vacuum Delivery System due to a risk of device breakage at the handle joint.
FDA•MODERATESiemens ARTIS pheno X-Ray SystemSiemens is recalling the ARTIS pheno x-ray system (Model 10849000) because it may incorrectly display an x-ray dose of zero during use.
2 products
FDA•MODERATEPhilips Spectral CT on RailsPhilips Spectral CT on Rails (Model 728334) requires a software update to address gantry positioning, message display, and menu option issues.
FDA•MODERATEUvlizer Handheld UV-C Germicidal WandUvlizer UV-C germicidal wands can expose users to unsafe UV-C radiation levels above international safety guidelines.
- FDA•MODERATEUvlizer Handheld UV-C Germicidal Wand
Uvlizer UV-C germicidal wands may expose users to unsafe UVC radiation levels above international safety guidelines.
FDA•MODERATECUSA Clarity C7000 ConsoleIntegra LifeSciences is recalling CUSA Clarity C7000 Console (Software 2.1.1.909) due to unresponsive touch screen.
FDA•MODERATECook Medical Arterial Pressure Monitoring TrayCook Medical is recalling Arterial Pressure Monitoring Trays because the labeled expiration dates exceed the actual shelf life of the devices.
19 products
FDA•MODERATETornier HRS Max Tuberosity Bodies and TrialsTornier is recalling mislabeled shoulder replacement components that are incompatible with the HRS Max system.
FDA•MODERATEVue Motion V12 Imaging SystemPhilips Vue Motion V12 (1017979) may display image frames out of sequence during dynamic imaging runs.
FDA•MODERATEBiDop 3 Pocket DopplerKoven Technology is recalling the BiDop 3 Pocket Doppler due to unauthorized fetal indication labeling.
2 products
FDA•MODERATEPhilips Allura Xper FD20 Biplane X-Ray SystemPhilips is recalling Allura Xper FD20 Biplane X-ray systems due to potential foot switch failure during imaging procedures.
22 products
FDA•MODERATEOXOID Microbact 12L Listeria Identification KitOxoid is recalling Microbact 12L Listeria Kit (MB1128A, Lot 4494873) due to risk of incorrect organism identification from ambiguous color reactions.
FDA•MODERATEInstinct Plus Endoscopic Clipping DeviceWilson-Cook Medical is recalling the Instinct Plus Endoscopic Clipping Device due to a potential malfunction.
FDA•MODERATESoft-Vu Angiographic CatheterAngiodynamics is recalling Soft-Vu Angiographic Catheters due to a manufacturing defect that may block the catheter hub.
20 products
FDA•MODERATEeTRAX Needle System Starter KitCivco is recalling the eTRAX Needle System Starter Kit 18G due to a risk of incorrect needle tip positioning on the user interface.
8 products
FDA•MODERATESIGNA Premier MR Scanner Magnet FittingsGE Healthcare is recalling SIGNA Premier MR scanners due to ferrous magnet fittings that could cause personnel injury during service.
FDA•MODERATEOlympus SOLTIVE Premium Laser SystemOlympus is recalling the SOLTIVE Premium Laser System (TFL-PLS) due to a power supply defect that may cause system failure or smoke.
2 products
FDA•MODERATECardinal Health Monoject Tuberculin Syringe 1 mLCardinal Health is recalling Monoject Tuberculin Syringes (Catalog 1180100777) that contain U-100 insulin syringes instead, risking dosing errors.
FDA•MODERATESpacelabs Multi-parameter Command Module Model 91496Spacelabs is recalling Model 91496 Multi-parameter Command Module due to circuit board issue causing inaccurate cardiac output readings.
FDA•MODERATEMedline Convenience Kits with 10mL SyringesMedline is recalling 10+ models of convenience kits with 10mL syringes due to unapproved design changes.
21 products
FDA•MODERATESynthes 2.4 Volt Locking Screw TapSynthes is recalling the 2.4 Volt Locking Screw Tap due to a labeling error that resulted in incorrect thread specifications.
2 products
FDA•MODERATEOlympus PKS Cutting ForcepsOlympus is recalling PKS Cutting Forceps (model 3005PK) due to a welding defect that may cause the jaw to break during use.
7 products
FDA•MODERATEMedline Namic GuidewiresMedline is recalling 50+ variants of Namic Guidewires, syringes, and tubing after their 510(k) regulatory clearances were rescinded.
28 products
FDA•MODERATEStryker CHROMOPHARE Softlit Ring Surgical LightStryker is recalling the CHROMOPHARE Softlit Ring Surgical Light System due to a risk of the ceiling cover falling.
FDA•MODERATEAtellica CH Enzymatic Hemoglobin A1c AssaySiemens is recalling the Atellica CH A1c_E assay due to potential depressed results when processed alongside RCRP on the same analyzer.
FDA•MODERATEElegance Anterior Cervical PlateClariance is recalling Elegance Anterior Cervical Plates due to the presence of burrs on the finished devices.
2 products
FDA•MODERATETECNIS Eyhance IOL with Simplicity Delivery SystemAMO is recalling TECNIS Eyhance IOLs with Simplicity Delivery Systems because the lens haptic may stick, preventing proper unfolding.
2 products
FDA•MODERATEXTANT MEDICAL Xpress Pedicle Screw SystemXTANT MEDICAL is recalling Xpress Pedicle Screw System 6.5 x 50 mm (X073-6555-DL) due to mislabeling identifying incorrect screw length.
FDA•MODERATEArtoura Breast Tissue ExpandersMentor Texas is recalling 10+ models of Artoura Breast Tissue Expanders due to a risk of needle tip breakage during use.
7 products
FDA•MODERATELeksell Gamma Knife Radiosurgery SystemElekta is recalling Leksell Gamma Knife Perfexion, Icon, and Esprit systems due to potential adapter misalignment during radiation delivery.
FDA•MODERATEAptima HPV AssayHologic is recalling the Aptima HPV assay (catalog 303585) due to the potential for invalid or false negative results.
FDA•MODERATECub Pediatric Crib Model FL19HStryker is recalling Cub Pediatric Crib Model FL19H over missing access door warning labels.
FDA•MODERATEWelch Allyn Spot Vision Screener VS100Welch Allyn is recalling the Spot Vision Screener VS100 due to a software issue that may cause screen flickering and trigger seizures.
FDA•MODERATESterile Radiology Procedure Kits Model DYNDH1491BMedline is recalling Sterile Radiology Procedure Kits Model DYNDH1491B due to potential sterile pouch packaging breach.
FDA•MODERATESee Luer Cap Set MPC-130Molded Products is recalling See Luer Cap Set MPC-130 due to threaded sleeve detachment risk.
FDA•MODERATEMedline Airway Exam Kit Biopsy ValveMedline is recalling Airway Exam Kits containing Olympus biopsy valves due to a risk of rubber fragment detachment and patient injury.
8 products
FDA•MODERATEConvatec EsteemBody Drainable PouchConvaTec is recalling EsteemBody Drainable Pouches due to a manufacturing issue that may cause leakage.
3 products
FDA•MODERATEMedtronic MiniMed Infusion PumpsMedtronic is recalling various MiniMed infusion pumps due to risks of insulin over- or under-delivery that can cause severe health complications.
14 products
FDA•MODERATEMedline ENFit G-Tube Connector KitsMedline is recalling G-Tube care and discharge kits due to connector defects that may cause leakage and fluid loss.
2 products
FDA•MODERATEOlympus Endoscope Suction ValvesOlympus is recalling MAJ-1443 and MAJ-1444 endoscope suction valves due to compatibility issues with specific automated reprocessors.
4 products
FDA•MODERATEBurlington Medical Wrap ApronsBurlington Medical is recalling Wrap Aprons due to potential attenuation degradation that may reduce their effective lifespan.
13 products
FDA•MODERATEEmbrace Shoulder Instrument Drill TowerWaldemar Link is recalling the Embrace Shoulder Instrument Drill Tower (645-081/62) due to incorrect article numbers in the surgical manual.
2 products
FDA•MODERATEBD Alaris System with Guardrails Suite MXBD Alaris System labeling lacks required TLS version specification for secure Wi-Fi communication with Point-of-Care Units.
FDA•MODERATEOrtho Dev. Trimax Lantern Knee System Drill PlateOrtho Dev. Trimax Drill Plates for the Lantern Knee System are recalled due to a manufacturing error that may cause excessive bone cuts.
2 products
FDA•MODERATEArtegraft Vascular GraftLeMaitre Vascular is recalling the Artegraft Vascular Graft due to a labeling mix-up on the outer packaging.
FDA•MODERATEPuracol and Puracol Plus Collagen Wound DressingsMedline is recalling Puracol and Puracol Plus wound dressings due to elevated endotoxin levels that may cause severe inflammatory responses.
FDA•MODERATEEndoVive Safety PEG KitBoston Scientific is recalling EndoVive Safety PEG Kits due to potentially compromised sterile packaging on the included ChloraPrep swabsticks.