FDA•MODERATE
L-Cath PICC S/L Peripherally Inserted Central Catheter
Argon Medical recalls L-Cath PICC catheters (REF 384539, 384464, 384516, 384463) due to hub cracking risk.
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Medical Devices Recalls
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FDA•MODERATEAMS Medical Convenience KitsWindstone Medical recalls 80+ AMS convenience kits over endotoxin risk in supplied sponges.
4 products
FDA•MODERATEMedline Convenience Kits with BD PurPrep 26 mLMedline recalls convenience kits with BD PurPrep 26 mL over Bacillus contamination.
4 products
FDA•MODERATEMedline Convenience Kits with Bard Silastic Foley CathetersMedline recalls convenience kits with Bard Silastic Foley Catheters over surface 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 Device with Shield TechnologyMicro Therapeutics recalls Pipeline Flex Embolization Device due to incorrect labeling of implant sizes.
2 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.