FDA•MODERATE
AMS DSAEK Pack Convenience Kit
Windstone recalls AMS DSAEK Pack kits (Part AMS12394B) due to detached blue BOPs in saline bags.
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Medical Devices Recalls
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FDA•MODERATEMedicaLyte Liquid Bicarbonate ConcentrateNipro recalls MedicaLyte hemodialysis concentrate (REF BC-100, BC+201) over high endotoxin levels.
4 products
FDA•MODERATESoft PVC Thoracic CathetersThis recall involves thoracic catheters manufactured for use in draining fluid or air from the chest cavity.
3 products
FDA•MODERATEDermaV Laser SystemLutronic recalls DermaV Laser System over burn risk from spark/loud noise at high fluences.
FDA•MODERATEHeartSine Samaritan PadsSee the official recall notice for details about this display summary.
FDA•MODERATEHalyard IV Start KitAVID Medical recalls Halyard IV Start Kits (REF KRIV26-02) due to sterility concerns with included applicators.
FDA•MODERATEBD Urinary Catheter Trays with CliniClean Pericare WipesBD Urinary Catheter Trays with CliniClean Pericare Wipes recalled over possible lubricant contamination causing skin irritation.
12 products
FDA•MODERATEGRANUFLO Dry Acid ConcentrateFresenius recalls GRANUFLO Dry Acid Concentrate (0FD2251-3B, 0FD3251-3B) over blue-green discoloration.
3 products
FDA•MODERATEFresenius 5008X Blood Tubing SetFresenius recalls 5008X blood tubing set (PN 03-5110-6) over blood leak risk.
4 products
FDA•MODERATEDiscofix Four Way StopcockB Braun recalls Discofix Stopcock Sets over incorrect expiration date on carton label.
- Device RecallFDA•MODERATELUX-Dx Insertable Cardiac Monitor System Software
Boston Scientific recalls LUX-Dx ICM server software (Model 7260) over delayed AF Burden Alerts.
3 products 
FDA•MODERATEVelys Enabling Tech Robotic-Assist StationMedos recalls Velys Robotic-Assist Station over software issue causing unintended arm movement.
- Device RecallFDA•MODERATEPhilips Brilliance CT Systems
Philips recalls Brilliance iCT and related CT systems over unintended radiation issue.
4 products 
FDA•MODERATEMedline Convenience Kits with BD ChloraPrep Clear 1mL ApplicatorsMedline recalls Convenience Kits with BD ChloraPrep Clear 1mL Applicators over possible open or incomplete seals.
13 products
FDA•MODERATEBaxter Novum IQ Syringe PumpBaxter recalls Novum IQ Syringe Pump over a software issue during multi-syringe infusions.
2 products
FDA•MODERATEHEALON EndoCoat PRO and DUET PRO IIJ&J Surgical Vision updates instructions for HEALON viscoelastic products used in cataract surgery over cannula insertion risks.
FDA•MODERATEMedline Convenience KitsMedline recalls two convenience kits over sterility breach risk in included BD ChloraPrep and FREPP applicators.
16 products
FDA•MODERATESTA Staclot Protein SDiagnostica Stago recalls STA Staclot Protein S reagent over QC drift within its 4-hour stability period.
FDA•MODERATEHalyard Medical Convenience KitsAVID Medical recalls 80+ Halyard convenience kit variants over endotoxin variability in Ritmed Neurological Sponges.
3 products- Device RecallFDA•MODERATEPortrait Core Services Software V1.1
GE Medical recalls Portrait Core Services Software V1.1 over possible loss of patient monitoring and alarm reset issues.
4 products 
FDA•MODERATEOlympus PowerSeal 5 mm Curved Jaw Sealer & DividerOlympus recalls PowerSeal 5 mm Curved Jaw Sealer & Divider over labeling error.
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•MODERATEAmerican Contract Systems Procedure KitsAmerican Contract Systems recalls 9 procedure kits due to potential endotoxin variability in included neurological sponges.
3 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•MODERATEMedtronic MiniMed 640G Insulin PumpMedtronic recalls loaner MiniMed 640G pumps (MMT-1711/1712) over cleaning damage risk.
3 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•MODERATELago XSpectral Instruments recalls Lago X over a missing "X-Ray On" banner during readiness check.
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