FDA•MODERATE
Olympus SOLTIVE Premium Laser System
Olympus is recalling the SOLTIVE Premium Laser System (TFL-PLS) due to a power supply defect that may cause system failure or smoke.
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Medical Devices Recalls
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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is recalling 50+ variants of Namic Guidewires, syringes, and tubing after their 510(k) regulatory clearances were rescinded.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•CRITICALAbiomed Impella Purge CassetteAbiomed is recalling Generation 1 purge cassettes sold individually and within Impella pump sets due to an increased risk of purge leaks.
2 products
FDA•MODERATEAptima HPV AssayHologic is recalling the Aptima HPV assay (catalog 303585) due to the potential for invalid or false negative results.
FDA•CRITICALHandy Solutions Neck & Shoulders Heating PadHandy Solutions Neck & Shoulders Heating Pad (Model 25607) may overheat and cause burns if folded or placed under the body.
FDA•MODERATECub Pediatric Crib Model FL19HStryker is recalling Cub Pediatric Crib Model FL19H over missing access door warning labels.
FDA•CRITICALBaxter Volara Respiratory Therapy Blue Ventilator Adapter ModuleBaxter is correcting its Volara Respiratory Therapy Blue Ventilator Adapter Module (M07937) due to risks of oxygen desaturation or barotrauma in home care use.
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•CRITICALAbiomed Automated Impella ControllerAbiomed is recalling Automated Impella Controllers due to a potential delay in the "Purge System Blocked" alarm.
2 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•CRITICALCentrosFLO Hemodialysis CathetersMerit Medical is recalling 20+ models of CentrosFLO Hemodialysis Catheters due to a sheath design defect that may cause serious injury.
5 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•CRITICALErbe Flexible CryoprobeErbe is recalling Flexible Cryoprobes because they may rupture or burst during activation.
4 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.
FDA•MODERATERefleXion X1 Radiotherapy System Model RXM1000RefleXion X1 Radiotherapy System Model RXM1000 recalled for software defect causing incorrect radiation dose delivery.
FDA•MODERATEID NOW Influenza A & B 2 Test KitAbbott is recalling ID NOW Influenza A & B 2 test kits (Model 427-000) due to an increased rate of invalid test results.
FDA•MODERATEArtelon FlexBand Dynamic MatrixInternational Life Sciences is recalling the Artelon FlexBand Dynamic Matrix due to a failure in bacterial endotoxin testing.
3 products
FDA•CRITICALTRUE METRIX Blood Glucose Meter Owner's BookletsTrividia Health is recalling TRUE METRIX meter manuals due to inadequate instructions for handling the E-5 error code.
7 products
FDA•MODERATEBD Kiestra ReadABD Kiestra ReadA modules may experience connectivity issues after a reboot, potentially delaying plate retrieval.
- Device RecallFDA•LOWCardiosave Battery Charging Station
Datascope is recalling Cardiosave Battery Charging Stations due to a screw defect in the left bay that prevents proper battery charging.
FDA•MODERATEHitachi Proton Beam Therapy SystemHitachi is recalling the PROBEAT-FR Proton Beam Therapy System due to a software anomaly that may cause patient positioning discrepancies.
2 products
FDA•MODERATECampy CVA MediumRemel is recalling Campy CVA Medium (R01272) due to low recovery of Campylobacter Jejuni on identified lots.
FDA•MODERATESTA Liatest D-Di KitDiagnostica Stago is recalling the STA Liatest D-Di kit due to a positive bias in D-Dimer measurements that may cause inaccurate test results.
2 products
FDA•MODERATESTA Liatest Free Protein S KitsDiagnostica Stago is recalling STA Liatest Free Protein S kits due to the risk of inaccurate test results for normal patient plasma levels.
FDA•MODERATEReact Health PHOENIX 5L Oxygen ConcentratorReact Health PHOENIX 5L Oxygen Concentrator recalled due to devices not meeting quality specifications.
FDA•MODERATEIvenix Infusion System Large Volume PumpFresenius Kabi is recalling the Ivenix Infusion System LVP due to a risk of the cassette loading lever breaking during use.
FDA•MODERATEEquinoxe Ergo Modular Impactor HandleExactech is recalling the Equinoxe Ergo Modular Impactor Handle due to a missing cross-pin that may cause device failure.
2 products