FDA•MODERATE
OXOS MC2 Portable X-Ray System
OXOS Medical recalls MC2 Portable X-Ray System due to overheating circuit board.
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Medical Devices Recalls
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FDA•MODERATEVector Pedicle Screw System Anti-TorqueInnovasis recalls Vector Pedicle Screw System anti-torque instrument (LS-749) due to undersized tip that may prevent engagement during surgery.
FDA•MODERATEmunevo DRIVE Powered Wheelchair Control SystemMunevo recalls wheelchair control systems over software calibration issue causing steering drift and collision risk.
FDA•MODERATENerivio Infinity BatteryTheranica recalls Nerivio Infinity over battery thermal-runway risk during charging.
- Device RecallFDA•MODERATEWASPLab WebApp Software
Copan WASP recalls WASPLab WebApp software over a result-overwrite issue.
FDA•MODERATERadial Jaw 4 Biopsy ForcepsBoston Scientific recalls Radial Jaw 4 biopsy forceps due to sterile barrier breach risk.
4 products
FDA•MODERATEFORWARD Oral Airway KitIntegrated Medcraft recalls FORWARD Oral Airway Kits due to possible occluded airway tip.
2 products- Device RecallFDA•MODERATEQuantum 4Front 2 Wheelchair Controller
Quantum Rehab recalls the Quantum 4Front 2 wheelchair controller over a software issue that can cause unexpected park brake stops.
13 products 
FDA•MODERATETherabody Theragun G4 PRO ChargerTherabody recalls Theragun G4 PRO charger due to fire risk from overheating cradle.
- Device RecallFDA•MODERATEREMISOL Advance Data Manager
Beckman Coulter recalls REMISOL Advance Data Manager over software error that may misreport combo assay results.
FDA•MODERATEPower Over Fiber Base ModuleTerex Utilities recalls Power Over Fiber Base Module due to missing laser certification and improper labeling.
FDA•MODERATEStryker Hoffmann II Connecting Rod Micro 3 x 30mmStryker recalls Hoffmann II Connecting Rod Micro 3 x 30mm due to potential cracking after cleaning and sterilization.
7 products
FDA•MODERATEGEM Premier 5000/7000 Bar Code Reader WandInstrumentation Laboratory recalls BCR Wand for GEM Premier 5000/7000 analyzers; may assign results to wrong patient ID.
10 products
FDA•MODERATEOsteoBallast 45 x 17.5 mmIsoTis recalls OsteoBallast 45 x 17.5 mm DBM mesh due to underfill, risking incomplete fusion.
FDA•MODERATEPhilips Brilliance CT ScannersPhilips recalls Brilliance CT scanners over possible scan trigger failure, risking patient rescan and extra radiation.
3 products
FDA•MODERATEAMS Spinal KitAMS SPINAL KIT recalled due to supplier quality issues with included Lidocaine HCl injection.
9 products
FDA•MODERATEMedtronic EOPA Arterial Cannula 22FRMedtronic recalls EOPA 22FR arterial cannula (Model 77422) over pinhole leak risk during bypass.
6 products
FDA•MODERATEArgon L-Cath PICC CathetersArgon recalls L-Cath PICC catheters over hub leak/crack risk.
2 products
FDA•MODERATEAMS Medical Convenience KitsWindstone Medical recalls AMS medical convenience kits due to potential endotoxin variability in included sponges.
6 products
FDA•MODERATEMedline Pediatric Open Heart KitMedline is recalling convenience kits containing BD PurPrep 26 mL over possible Bacillus contamination.
4 products
FDA•MODERATEMedline Convenience Kits with Bard Silastic Foley CathetersMedline recalls convenience kits with Bard Silastic Foley Catheters (sizes 16, 18, 20) due to surface raw material risk.
9 products
FDA•MODERATEMiniMed Go AppMedtronic MiniMed recalls MiniMed Go App v1.0.0 and v1.1.0 over nighttime alert failure risking missed insulin doses.
FDA•MODERATEFlexible Hystero-Fiberscope KitsKarl Storz recalls hysteroscope kits with expired endoscopic seals that may compromise sterility.
FDA•MODERATESafeOp Patient InterfaceAlphatec Spine recalls SafeOp Patient Interface over software issue causing tEMG loss, system faults, and reboot prompts.
FDA•MODERATESnapshotGLO Wound Imaging DeviceKent Imaging recalls SnapshotGLO wound imaging devices due to battery charging failure.
FDA•MODERATEPipeline Flex Embolization DeviceMicro Therapeutics recalls Pipeline Flex Embolization Devices due to incorrect labeling of implant sizes.
4 products
FDA•MODERATEHalyard Standard Line Insertion PackAVID Medical recalls Halyard Standard Line Insertion Pack (Model PVHM234-01) over silicone seal defects causing leakage.
- Device RecallFDA•MODERATEEmano Flow v2.0.0
Emano Flow v2.0.0 recalled due to audio sampling mismatch causing biased flow rate and volume estimates.
FDA•MODERATETheraSphere 360 Y-90 Management PlatformBoston Scientific recalls TheraSphere 360 Y-90 Platform due to software anomaly causing incorrect dose calculations.
FDA•MODERATEOlympus High Flow Insufflation Unit UHI-4Olympus recalls UHI-4 insufflation unit over unexpected display shutdown and air delivery loss.
FDA•MODERATEVentriculostomy KitMedtronic is recalling the Ventriculostomy Kit due to endotoxin levels that exceed safety limits for cerebrospinal fluid contact.
FDA•MODERATEPenumbra RED 68 Reperfusion CatheterPenumbra is recalling the RED 68 Reperfusion Catheter due to a manufacturing issue that may cause the device to fracture during use.
FDA•MODERATEWilcox BOSS Xe Aiming LasersWilcox is recalling all BOSS Xe aiming lasers to implement a safety-related software enhancement.
- Device RecallFDA•MODERATE3mensio Vascular Fenestrated Workstation Software
3mensio software may report inaccurate cardiovascular measurements when analyzing specific Philips 3D echo datasets.
FDA•MODERATESilent Nite Sleep ApplianceThe Silent Nite Sleep Appliance (Model SILNT) is being recalled because it lacks required FDA clearance.
FDA•MODERATEOlympus 4K UHD LCD MonitorOlympus is recalling the 4K UHD LCD Monitor (model OEV321UH) due to a potential connector fault that may cause image loss or abnormalities.
FDA•MODERATEAVID Medical Eye Pack Convenience KitAVID Medical is recalling the Eye Pack convenience kit (Model LVEY27) due to an incorrect concentration of Betadine solution.
FDA•MODERATESeaSpine Polyaxial HeadSeaSpine is recalling the Polyaxial Head due to a manufacturing error that may cause the component to detach during surgery.
FDA•MODERATEFerno Power F2 Powered Fastening SystemFerno is recalling the Power F2 Powered Fastening System due to a risk of the rail mechanism lodging and preventing stretcher movement.
FDA•MODERATEHotline Fluid Warming SetICU Medical is recalling Hotline Fluid Warming Sets due to a risk of leakage at the tubing-to-connector bond.
FDA•MODERATEParagon 28 Phantom Intramedullary Nail System Guide RodParagon 28 is recalling the Phantom Hindfoot TTC/TC Ball Tipped Guide Rod (item P31-955-1800-S) due to sterile packaging breaches.
FDA•MODERATEBoston Scientific FARASTAR PFA GeneratorBoston Scientific is recalling FARASTAR PFA generators (Product ID 61M401) due to incompatibility with the FARAPOINT PFA catheter.
FDA•MODERATEFARASTAR Ablation Generator and FARAPOINT CatheterBoston Scientific recalls FARASTAR generator and ablation catheter due to missing IFU info for FARAPOINT catheter.
3 products
FDA•MODERATEFARADRIVE Steerable Sheath Clear IDEBoston Scientific recalls FARADRIVE Steerable Sheath Clear IDE over valve damage risk that may cause air embolism.
4 products
FDA•MODERATETosoh ST AIA-Pack TestosteroneTosoh is recalling ST AIA-Pack Testosterone test kits due to potential for inaccurate results that may impact clinical treatment decisions.
FDA•MODERATEPhotera 400 Phototherapy DeviceDaavlin recalls Photera 400 phototherapy device due to incorrect UV sensor gain causing inaccurate output.
3 products
FDA•MODERATEMedline Total Knee Pack Mixing Bowls and SpatulasMedline recalls Total Knee Pack kits with Zimmer Biomet mixing bowls and spatulas over sterility risk.
2 products
FDA•MODERATEVasoview Hemopro 2 Endoscopic Vessel Harvesting SystemVasoview Hemopro 2 Endoscopic Vessel Harvesting System is recalled due to an out-of-specification sterilization dose.
FDA•MODERATEMedtronic DLP Pediatric Arterial CannulaMedtronic recalls DLP Pediatric Arterial Cannula (CFN 77010) over loose foreign material with trace blood.
2 products
FDA•MODERATEPapablic Replacement Brush HeadsPapablic is recalling replacement brush heads over a choking hazard from breakage.
2 products