FDA•MODERATE
Olympus PowerSeal 5 mm Curved Jaw Sealer & Divider
Olympus recalls PowerSeal 5 mm Curved Jaw Sealer & Divider over labeling error.
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Medical Devices Recalls
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FDA•MODERATEIMRIS ORT200 Operating Room TableIMRIS recalls ORT200 operating room tables due to actuator/lock failure risk of unintended movement.
2 products
FDA•MODERATEhealthmark ProChek-II TestHealthmark recalls ProChek-II tests (PT-313, PT-201-12) over expired ingredient risk.
2 products- Device RecallFDA•MODERATEFUJIFILM Synapse PACS Software
FUJIFILM Synapse PACS v7.4.310 recalled due to inaccurate ruler measurements.
FDA•MODERATEMedline Femoral Pack and FEVAR KitsMedline recalls Femoral Pack and FEVAR kits due to potentially contaminated component.
14 products
FDA•MODERATEGENESYS CrossFT Suture AnchorConMed recalls GENESYS CrossFT Suture Anchor (REF CFBC-5502B) due to incorrect implant card.
FDA•MODERATEFresenius 2008T BlueStar Hemodialysis MachineFresenius recalls 2008T BlueStar Hemodialysis Machine over flow, no water, and temperature alarms.
FDA•MODERATEStructur 2 SC Temporary Resin Cartridge RefillHenry Schein recalls Structur 2 SC Temporary Resin Cartridge Refill 75Gm due to incorrect packaging and IFU.
2 products
FDA•MODERATEMidmark IQecg Digital ECGMidmark recalls IQecg Digital ECG over incorrect ECG waveforms and BPM calculations.
2 products
FDA•MODERATECanon Alphenix Ceiling Movement Gear ScrewsCanon recalls Alphenix X-ray systems (INFX-8000C/F/V) over loose ceiling gear screws.
FDA•MODERATEHalyard Davinci TruCustom Foley TrayHalyard Davinci TruCustom Foley tray recalled over missing latex warning on StatLock component.
8 products
FDA•MODERATEMerge PACS and Merge OrthoPACSMerge PACS and OrthoPACS recalled due to inaccurate measurement display.
FDA•MODERATEAmerican Contract System Convenience KitAmerican Contract Systems recalls Convenience Kit CV B PACK (TNCB10AM) due to catheter performance failure.
4 products- Device RecallFDA•MODERATEPhilips Incisive CT Software
Philips Incisive CT software V4.5/V5.0 recalled for Bolus Tracking scan trigger failure.
FDA•MODERATEMedline Trach Tube KitMedline recalls Trach Tube Kit (SKU DYKM2330) over labeling discrepancy.
FDA•MODERATEOnli Hydrophilic Urethral Intermittent CathetersHollister recalls Onli intermittent catheters due to a protrusion defect that may cause genitourinary trauma or bleeding.
2 products
FDA•MODERATEMedline ENT Convenience KitsMedline recalls ENT/sinus kits with Pilling Wecksorb Neurosponges over endotoxin risk.
6 products
FDA•CRITICALENROUTE Transcarotid Neuroprotection SystemBoston Scientific recalls ENROUTE Transcarotid Neuroprotection System over sheath tip separation risk.
2 products
FDA•MODERATEEsteem Body Soft Convex Urostomy PouchConvaTec recalls Esteem Body Soft Convex Urostomy Pouches due to cap leakage risk.
FDA•MODERATEVeritas Standard Glenoid Baseplaterestor3d recalls Veritas Standard Glenoid Baseplate over screw hole machining defect.
2 products
FDA•MODERATEFDI Automated Field Steam SterilizerFDI recalls Automated Field Steam Sterilizer over possible ground continuity loss in the water recovery system connector.
FDA•MODERATESyva EMIT 2000 Quinidine AssaySiemens recalls Syva EMIT 2000 Quinidine Assay over precision issues that may cause elevated readings and risk of cardiac arrhythmias.
2 products- Device RecallFDA•MODERATEBeckman Coulter DxC 500i Analyzer Modules
Beckman Coulter recalls DxC 500i Analyzer Modules (software ≤1.5) over a Parameter Package import defect that can yield erroneous results.
2 products 
FDA•LOWParagon 28 Navicular Cage Foot ImplantParagon 28 recalls Navicular Cage foot implant (Model 6123S R) due to elevated oxygen levels.
2 products
FDA•MODERATEGentherm Thermal Regulating SystemGentherm recalls thermal regulating systems over CPU board overheating that may cause shutdown.
3 products
FDA•MODERATEKidneyVault Portable Renal Perfusion SystemParagonix recalls KidneyVault perfusion system over firmware defect causing blank screen.
FDA•MODERATESiemens Healthineers Immulite 2000 SYP Syphilis ScreenSiemens Healthineers recalls Immulite 2000 SYP Syphilis Screen due to negative bias risk.
2 products
FDA•MODERATEHalyard LAVH Pack Clearify Visualization SystemAVID Medical recalls Halyard LAVH Pack (USAR053-11) due to possible leakage of the Clearify Visualization System.
2 products
FDA•MODERATEGetinge SERVO-U/SERVO-N Y Sensor ModuleGetinge recalls SERVO-U/N Y sensor module over missing safety electrical testing.
2 products
FDA•MODERATEOverStitch Suture CinchBoston Scientific recalls OverStitch Suture Cinch over deployment and suture-cutting failures.
2 products
FDA•MODERATETD Navio Midi Speech Generating DeviceTobii Dynavox recalls TD Navio Midi speech device over battery tab damage risk.
2 products
FDA•MODERATEArrow-LOK ImplantArrowhead recalls Arrow-LOK Implants over missing gamma radiation audit, risking infection.
2 products- Device RecallFDA•MODERATEARVIS Surgical Navigation System Gen 2
Kico Knee recalls ARVIS Surgical Navigation System Gen 2 over tilted eyepiece image from sensor issue.
2 products 
FDA•MODERATEPhilips Cardiac Workstation 5000Philips recalls Cardiac Workstation 5000 over intermittent inaccurate heart-rate data.
2 products
FDA•MODERATEDentsply Sirona Capsule MixerDentsply Sirona Capsule Mixer recalled over electrical discharge risk when unplugged.
FDA•MODERATEIntersurgical One-Piece Guedel AirwayIntersurgical recalls One-Piece Guedel Airway, size 00, ISO 5.0, Blue, due to potential occlusion.
2 products- Device RecallFDA•MODERATEHamilton Microlab STAR PCT Software
Foundation Medicine recalls Hamilton Microlab STAR PCT v2.0.0 over spontaneous software closures.
FDA•MODERATEEndoFLIP 1 SystemCovidien recalls EndoFLIP 1 System due to 24-hour limit flagging products as expired.
2 products
FDA•MODERATEPresource KitsCardinal Health is recalling multiple Presource procedural kits due to possible endotoxin contamination.
13 products
FDA•MODERATEBD Intravascular Administration and Extension SetsBD recalls IV administration and extension sets due to possible sterilization failure.
2 products
FDA•MODERATEERBECRYO 2 Cryosurgical UnitErbe USA recalls ERBECRYO 2 Cryosurgical Unit (Model 10402-000) over risk of cryoprobe rupture from CO2 leak.
FDA•MODERATEBIOFIRE Respiratory Panel 2.1BioFire recalls BIOFIRE Respiratory Panel 2.1 over increased false negatives.
FDA•MODERATEStraumann Bone Level Tapered ImplantStraumann recalls BLT Implant D 4.1mm RC SLActive 14mm due to possible 12mm length mismatch.
FDA•CRITICALBaxter Duo-Vent Solution SetBaxter recalls Duo-Vent Solution Set (1C8507) over air bubble risk in drip chamber and tubing.
FDA•MODERATEER-Spec Vaginal SpeculumOBP Medical recalls ER-Spec X-Small vaginal speculums over a sharp-edge burr risk.
FDA•MODERATEGM Helix Dental ImplantStraumann recalls GM Helix dental implants over a packaging label mismatch that could cause bone compression.
FDA•MODERATEPhilips Allura Xper FDPhilips recalls Allura Xper FD x-ray systems over firmware issue causing loss of geometry movements.
FDA•MODERATEGlidesheath Slender A-KitTerumo recalls Glidesheath Slender A-Kit 6F 10cm .021GW (60-1060) due to wrong guidewire.
FDA•MODERATENeisseria meningitidis Gp C 2ml/VLRemel recalls Neisseria meningitidis Gp C 2ml/VL (R30166901) for failing to test positive within 60 seconds.
FDA•MODERATEMedline Micro-Kill Bleach Germicidal WipesMedline Micro-Kill Bleach Germicidal Wipes may lose disinfecting strength before their 12-month shelf life ends.
4 products