FDA•MODERATE
Gentuity HF-OCT Imaging System
Gentuity is correcting HF-OCT Imaging System software (versions 21.11–23.3.13) to prevent inaccurate longitudinal measurements during imaging.
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Medical Devices Recalls
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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FDA•MODERATEMedline Namic GuidewiresMedline recalls Namic syringes, guidewires, and tubing due to rescinded 510(k) clearances.
28 products
FDA•MODERATEMedline Convenience Kits with 10mL Polycarbonate SyringesMedline is recalling convenience kits containing select 10mL polycarbonate syringes due to potential cracking or breakage of the syringe barrel and/or plunger, which could result in loss of sterility and potential patient infection.
21 products
FDA•MODERATEOlympus Thunderbeat II ShearsOlympus recalls Thunderbeat II Shears (model TB2-0520FC) over distal tip detachment risk.
4 products
FDA•MODERATELeadCare II Blood Lead Test KitsMagellan recalls LeadCare II blood lead test kits over false elevated results from certain micro-collection devices.
4 products
FDA•MODERATECUSA Clarity C7000 ConsoleIntegra LifeSciences is recalling CUSA Clarity C7000 Console (Software 2.1.1.909) due to unresponsive touch screen.
FDA•MODERATESoft-Vu Angiographic CatheterAngiodynamics recalls Soft-Vu Angiographic Catheters due to guidewire passage defect.
20 products
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•MODERATEMedline CENTURION Circumcision KitMedline is recalling CENTURION Circumcision Kit (CIT7050F) due to one lot distributed without sterilization.
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•MODERATECytal Wound Matrix 2-Layer 5x5 cmCytal Wound Matrix 2-Layer 5x5 cm recalled over out-of-specification endotoxin results.
5 products
FDA•MODERATEReact Health PHOENIX 5L Oxygen ConcentratorReact Health PHOENIX 5L Oxygen Concentrator recalled due to devices not meeting quality specifications.
FDA•MODERATEElegance Anterior Cervical PlatesClariance-SAS is recalling Elegance Anterior Cervical Plates due to the presence of burrs on the finished product.
2 products
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•MODERATERemel Yeastone BrothRemel is recalling Yeastone Broth due to the potential for incorrect antimicrobial susceptibility testing results.
FDA•MODERATELinkBio CORE WorkstationLinkBio CORE Workstation (87-9136) may display incorrect Planning Date on Start Case menu.
- Device RecallFDA•MODERATEPhilips AneurysmFlow Software
Philips is recalling AneurysmFlow software because the MAFA ratio provides unreliable prognostic data for aneurysm treatment decisions.
FDA•MODERATEArjo Tenor Mobile Patient LiftArjo Tenor patient lifts (Models KHA1000 US, KHA1010 US) recalled for actuator failure risk causing sudden arm drop.
FDA•MODERATEStryker Sustainability Solution Tourniquet CuffsStryker is recalling tourniquet cuffs that may detach from the bladder, preventing the device from maintaining pressure.
FDA•MODERATEB.R.A.H.M.S PlGF Plus KRYPTORBrahms recalls PlGF Plus KRYPTOR test (REF 859075N) due to QC underestimation risk causing false preeclampsia risk classification.
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•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•MODERATECook Arterial Pressure Monitoring TrayCook recalls Arterial Pressure Monitoring Trays due to incorrect expiration dates.
19 products
FDA•MODERATESee Luer Cap Set MPC-130Molded Products is recalling See Luer Cap Set MPC-130 due to threaded sleeve detachment risk.
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•MODERATETornier HRS Max Tuberosity Body and Trial PartsTornier is recalling shoulder system components incorrectly labeled as HRS Max parts, as they are incompatible with the HRS Max system.
FDA•MODERATEMedline Anterior Hip Pack Biopsy ValveMedline is recalling Anterior Hip Packs containing Olympus biopsy valves over risk of rubber fragment detachment.
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•MODERATEMedtronic MiniMed Insulin PumpsMedtronic MiniMed recalls all Paradigm, 600, and BLE 700 series insulin pumps over insulin delivery errors that can cause severe hypoglycemia or ketoacidosis.
14 products
FDA•MODERATEBurlington Medical Wrap ApronsBurlington Medical wrap aprons may lose shielding effectiveness over time.
13 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•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•MODERATEeTRAX Needle System Starter Kit 12GCivco recalls eTRAX Needle System Starter Kit 12G (Part 667-149) due to sensor programming error causing incorrect needle tip position.
8 products
FDA•MODERATESynthes VOLT Locking Screw TapSynthes recalls VOLT Locking and Cortical Screw Taps due to incorrect thread from a lot swap.
2 products
FDA•MODERATEOlympus SOLTIVE Laser SystemOlympus recalls SOLTIVE laser systems (TFL-SLS, TFL-PLS) due to power supply defect that may cause inoperability and smoke.
2 products
FDA•MODERATEArtoura Breast Tissue ExpandersA recall was issued for Artoura Breast Tissue Expanders due to infusion sets that may contain dull or blunt needle tips.
7 products
FDA•MODERATEPhilips Allura Xper FD10/FD20 Wired Foot SwitchPhilips recalls Allura Xper FD10/FD20 systems over wired foot switch failure causing intermittent X-ray imaging.
22 products
FDA•MODERATEBD Kiestra ReadABD Kiestra ReadA is recalled due to potential connectivity issues causing delays in plate retrieval after a system reboot.
FDA•MODERATEMedline ENFit G-Tube ConnectorMedline recalls ENFit G-tube connectors in care/discharge kits over seal failure and leakage risk.
2 products
FDA•MODERATEEmbrace Drill TowerWaldemar Link recalls Embrace Drill Tower instruments over mixed-up article numbers in the surgical technique overview.
2 products
FDA•MODERATEJiffy Original Composite Polisher Cups (Coarse)Ultradent is recalling Jiffy Original Composite Polisher Cups (Coarse) 12pk, REF 7011, due to crumbling and breakage risk.
FDA•MODERATERefleXion X1 Radiotherapy System Model RXM1000RefleXion X1 Radiotherapy System Model RXM1000 recalled for software defect causing incorrect radiation dose delivery.
FDA•MODERATESterile Radiology Procedure Kits Model DYNDH1491BMedline is recalling Sterile Radiology Procedure Kits Model DYNDH1491B due to potential sterile pouch packaging breach.
FDA•MODERATEStryker CHROMOPHARE Softlit Ring Surgical LightStryker is recalling the CHROMOPHARE Softlit Ring Surgical Light System due to a potential ceiling cover support failure.
FDA•MODERATEParadise Ultrasound Renal Denervation CatheterReCor Medical is recalling the Paradise Ultrasound Renal Denervation Catheter (Model PRDS-068-02) as these units were intended to be scrapped.
3 products
FDA•MODERATEVue Motion V12 Imaging SystemPhilips Vue Motion V12 (1017979) may display image frames out of sequence during dynamic imaging runs.
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•MODERATEAtellica CH Enzymatic Hemoglobin A1c AssaySiemens is recalling the Atellica CH A1c_E assay due to a risk of depressed results when used alongside the RCRP assay on the same analyzer.