FDA•MODERATE
Diversatek Healthcare Viper 3-Stage Fixed Wire Balloon Dilator
Diversatek Healthcare is recalling the Viper 3-Stage Fixed Wire Balloon Dilator due to incorrect labeling of balloon sizes and pressures.
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Medical Devices Recalls
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FDA•MODERATEDimension Creatinine Flex Reagent CartridgeSiemens is recalling Dimension Creatinine Flex reagent cartridges (lots GA6307, BA7005) due to potential imprecision in patient creatinine results.
FDA•MODERATEStraumann Custom Abutment TiStraumann is recalling custom abutments manufactured with incorrect raw material.
2 products
FDA•CRITICALMedical Action Industries Pack Cath BHHMedical Action Industries is recalling Pack Cath BHH kits due to a defect in the syringe adapter that may cause it to disconnect during use.
FDA•MODERATEMedline CENTURION Circumcision KitMedline is recalling CENTURION Circumcision Kit (CIT7050F) due to one lot distributed without sterilization.
FDA•MODERATEAccess Total T4 CalibratorBeckman Coulter is recalling Access Total T4 Calibrator (Catalog No. 33805) due to negative bias causing falsely low results on DxI 600/800 instruments.
FDA•MODERATEFlamingo Funnel SmallSurgiSmoke Solutions is recalling the Flamingo Funnel Small due to a manufacturing error involving non-gamma compatible sterilization drapes.
3 products
FDA•MODERATEMedline Universal Central/Art Line Insertion KitMedline is recalling convenience kits containing non-sterile alcohol prep pads due to potential bacterial contamination.
10 products
FDA•MODERATEMagellan Diagnostics LeadCare II Blood Lead Test KitsMagellan Diagnostics is recalling LeadCare II blood lead test kits due to the risk of false positive results.
4 products
FDA•CRITICALHalyard Cardiac Cath Pack Syringe AdaptorAVID Medical is recalling Cardiac Cath Pack kits due to a risk of the syringe adaptor disconnecting during use.
10 products
FDA•MODERATEB.R.A.H.M.S PlGF Plus KRYPTOR In Vitro Diagnostic TestB.R.A.H.M.S PlGF Plus KRYPTOR (Catalog 859075N) recalled for out-of-range quality control values that may cause falsely elevated preeclampsia risk results.
FDA•MODERATEStryker Sustainability Solution Tourniquet CuffsStryker is recalling tourniquet cuffs that may fail to maintain pressure due to a potential detachment at the welding connection.
FDA•MODERATEARTIS Pheno VE30A and VE40A Imaging SystemSiemens is recalling ARTIS Pheno VE30A and VE40A imaging systems (Model 10849000) due to unregulated dose causing unintentional low-dose radiation exposure.
FDA•MODERATEMesh Style Tip ProtectorsHealthmark Industries is recalling Mesh Style Tip Protectors (models CSW-03-2.0 and CSW-04-4.0) due to a lack of FDA clearance.
FDA•MODERATELinkBio CORE WorkstationLinkBio CORE Workstation (87-9136) may display incorrect Planning Date on Start Case menu.
FDA•CRITICALOmnipod 5 PodsInsulet is recalling Omnipod 5 Pods due to a cannula tear that can cause insulin leakage, leading to dangerous under-delivery of insulin.
FDA•MODERATEiLet Bionic PancreasBeta Bionics is recalling iLet Bionic Pancreas (software 1.4.2–1.4.3) for Dexcom G7 compatibility issues that may disable glucose correction dosing.
FDA•MODERATEB Braun Infusion Pump Administration SetsWindstone Medical Packaging is recalling Pre Op Kits containing B Braun IV administration sets due to potential medication backflow or priming issues.
3 products
FDA•MODERATEMedtronic Sphere-9 Cardiac Ablation CatheterMedtronic Sphere-9 Catheter (Model AFR-00001) may cause ventricular fibrillation in patients with Biotronik ICDs or CRT-Ds during radiofrequency ablation therapy.
FDA•MODERATEArrow Echogenic Introducer NeedleArrow is recalling the Echogenic Introducer Needle due to a manufacturing error involving the device's liquid adhesive.
13 products
FDA•CRITICALIntuitive SureForm 30 Gray ReloadsIntuitive Surgical is recalling SureForm 30 Gray Reloads (Ref 48230M-05, 48230M-06) due to the risk of an incomplete staple line.
FDA•MODERATEARTIS pheno and ARTIS Icono Biplane X-ray SystemSiemens is recalling ARTIS pheno and ARTIS Icono X-ray systems (Models 10849000, 11327600, 11328100, 11327700) due to erroneous dose display during patient exams.
FDA•MODERATEArjo Tenor Mobile Patient LiftArjo Tenor patient lifts (Models KHA1000 US, KHA1010 US) recalled for actuator failure risk causing sudden arm drop.
FDA•MODERATEnanOss 3D Advanced Bone Graft SubstituteXTANT Medical is recalling nanOss 3D bone graft substitutes due to an incorrect five-year shelf life label instead of the validated four years.
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 Kits (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 (Model VAC-6000MT) due to a risk of device breakage during use.
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 device's actual shelf life.
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 because its labeling includes an uncleared fetal indication for use.
2 products
FDA•MODERATEPhilips Allura Xper FD20 Biplane X-Ray SystemPhilips is recalling Allura Xper FD20 Biplane X-ray systems due to potential wired foot switch failure during imaging.
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 for the device to 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•CRITICALPhilips Respironics Trilogy Evo VentilatorPhilips Respironics is recalling Trilogy Evo ventilators (software v1.05.15.00) due to potential tidal volume delivery discrepancies.
4 products
FDA•CRITICALPhilips Respironics Trilogy Evo O2 VentilatorPhilips Respironics is recalling Trilogy Evo O2 ventilators (software v1.05.15.00) because the obstruction alarm may fail to trigger.
4 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•CRITICALMedline NAMIC Angiographic Syringe KitsMedline is recalling NAMIC angiographic syringe kits due to a risk of the rotating adaptor disconnecting during use.
24 products
FDA•MODERATEOlympus SOLTIVE Premium Laser SystemOlympus is recalling the SOLTIVE Premium Laser System due to a power supply defect that may cause inoperability, smoke, or a burning smell.
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+ convenience kits containing 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 the inclusion of incorrect thread components.
2 products