Device Recall
FDA•MODERATE
FUJIFILM Synapse PACS Software
FUJIFILM Synapse PACS v7.4.310 recalled due to inaccurate ruler measurements.
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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•LOWIbuprofen Oral Suspension SyringesSafecor recalls Ibuprofen oral suspension syringes over cross-contamination risk.
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•MODERATERemedy+ Recovery Dogswell Pet WormerRemedy+ Recovery Dogswell Pet Wormer recalled due to adverse event complaints.
FDA•MODERATELevothyroxine Sodium Tablets 25 mcgAccord recalls Levothyroxine 25 mcg tablets due to subpotency.
12 products
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•MODERATEDouble Golden Fish Galanga PowderTang's Family recalls Double Golden Fish Galanga Powder due to elevated lead levels.
FDA•MODERATEAmerican Contract Systems Procedure KitsAmerican Contract Systems recalls 9 procedure kits due to potential endotoxin variability in included neurological sponges.
3 products
FDA•MODERATEPrince Bakery: 4 Enriched Bleached FloursPrince Bakery recalls Italian and French breads over undeclared sesame in the ingredient statement.
4 products
FDA•MODERATEGifford's Power Play Fudge Ice CreamGifford's recalls Power Play Fudge ice cream (1 qt) over possible rubber pieces.
FDA•MODERATECarbamazepine Tablets 200mgGSMS recalls Carbamazepine 200mg tablets over black specks.
FDA•MODERATEAcamprosate Calcium 333 mg TabletsMylan recalls Acamprosate Calcium 333 mg tablets over dissolution failure.
FDA•MODERATEEsteem Body Soft Convex Urostomy PouchConvaTec recalls Esteem Body Soft Convex Urostomy Pouches due to cap leakage risk.
FDA•MODERATEWhole BloodSuncoast Communities Blood Bank recalls whole blood due to incomplete donor eligibility screening.
2 products
FDA•MODERATEVeritas Standard Glenoid Baseplaterestor3d recalls Veritas Standard Glenoid Baseplate over screw hole machining defect.
2 products
FDA•MODERATEOutshine Fruit Bar: 6 productsDreyer's recalls Outshine Fruit Bars over possible glass pieces.
6 products
FDA•MODERATEProlon Everyday Apulian Almond & Cocoa SpreadProlon Apulian Almond & Cocoa Spread recalled for undeclared tree nuts (hazelnut, cashew, pistachio).
FDA•MODERATECarbamazepine Tablets 200mgTaro recalls Carbamazepine 200mg tablets over black specks.
2 products
FDA•MODERATERed Blood Cells, Leukocytes ReducedOneBlood recalls Red Blood Cells, Leukocytes Reduced from a misregistered donor.
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•MODERATEProtein Cereal Cocoa CrunchProtein Cereal Cocoa Crunch recalled over undeclared soy allergen.
FDA•MODERATEPEMRYDI RTU Pemetrexed InjectionShilpa Medicare recalls PEMRYDI RTU vials over green discoloration.
2 products
FDA•MODERATELibtayo (cemiplimab-rwlc) InjectionRegeneron recalls Libtayo (cemiplimab-rwlc) Injection 350 mg/7 mL over sterility concerns.
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•MODERATEProspector Popcorn: 4 productsProspector Popcorn recalls gourmet popcorn varieties over inaccurate nutrient declarations.
4 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