November 5, 2025Medical DevicesFDA
ICU Medical, Inc. recalls ICU Medical Graduated Connector w/ChemoLock Port REF: CL3900
Hazard: Port weld of drug transfer device may separate or break during use and potentially result in a leak.
November 5, 2025Medical DevicesFDA
ICU Medical, Inc. recalls ICU Medical 21" Ext Set w/ChemoLock Port, Clamp, Graduated Connector REF: CL3360
Hazard: Port weld of drug transfer device may separate or break during use and potentially result in a leak.
November 5, 2025Medical DevicesFDA
ICU Medical, Inc. recalls ICU Medical ChemoLock Port REF: CL2100
Hazard: Port weld of drug transfer device may separate or break during use and potentially result in a leak.
November 5, 2025Medical DevicesFDA
ICU Medical, Inc. recalls ICU Medical ChemoLock 13mm Closed Vial Spike REF: CL-82
Hazard: Port weld of drug transfer device may separate or break during use and potentially result in a leak.
November 5, 2025Medical DevicesFDA
ICU Medical, Inc. recalls ICU Medical ChemoLock Closed Vial Spike w/Skirt, 5 Units REF: CL-80S-5
Hazard: Port weld of drug transfer device may separate or break during use and potentially result in a leak.
November 5, 2025Medical DevicesFDA
ICU Medical, Inc. recalls ICU Medical ChemoLock Vial Spike, 20mm REF: CL-80S
Hazard: Port weld of drug transfer device may separate or break during use and potentially result in a leak.
November 5, 2025Medical DevicesFDA
ICU Medical, Inc. recalls ICU Medical ChemoLock Closed Vial Spike REF: CL-80
Hazard: Port weld of drug transfer device may separate or break during use and potentially result in a leak.
November 5, 2025Medical DevicesFDA
ICU Medical, Inc. recalls ICU Medical ChemoLock Vented Vial Spike, 13mm REF: CL-72
Hazard: Port weld of drug transfer device may separate or break during use and potentially result in a leak.
November 5, 2025Medical DevicesFDA
ICU Medical, Inc. recalls ICU Medical ChemoLock Vented Vial Spike, 20mm REF: CL-70S
Hazard: Port weld of drug transfer device may separate or break during use and potentially result in a leak.
November 5, 2025Medical DevicesFDA
ICU Medical, Inc. recalls ICU Medical ChemoLock Universal Vented Vial Spike REF: CL-70
Hazard: Port weld of drug transfer device may separate or break during use and potentially result in a leak.
November 5, 2025Medical DevicesFDA
ICU Medical, Inc. recalls ICU Medical Double ChemoLock Port Syringe Transfer Set REF: CL-33
Hazard: Port weld of drug transfer device may separate or break during use and potentially result in a leak.
November 5, 2025Medical DevicesFDA
ICU Medical, Inc. recalls ICU Medical ChemoLock Bag Spike REF: CL-10
Hazard: Port weld of drug transfer device may separate or break during use and potentially result in a leak.
November 5, 2025Medical DevicesFDA
ICU Medical, Inc. recalls ICU Medical 73" (185 cm) Appx 2.5 ml, Ext Set, Smallbore w/ChemoLock Port, Clamp, ChemoLock w/Red Cap REF: CL4176
Hazard: Port weld of drug transfer device may separate or break during use and potentially result in a leak.
November 5, 2025Medical DevicesFDA
ICU Medical, Inc. recalls ICU Medical 60" (152 cm) Appx 1.2 ml, Ext Set, Smallbore w/ChemoLock Port, Clamp, Spiros w/Red Cap REF: CL4173
Hazard: Port weld of drug transfer device may separate or break during use and potentially result in a leak.
November 5, 2025Medical DevicesFDA
ICU Medical, Inc. recalls ICU Medical 45" (114 cm) Appx 1.7 ml, Smallbore Ext Set w/Spiros w/Red Cap, Anti-Siphon Valve, Clamp, Y-Connector w/Che
Hazard: Port weld of drug transfer device may separate or break during use and potentially result in a leak.
November 5, 2025Medical DevicesFDA
ICU Medical, Inc. recalls ICU Medical Oncology Transfer Kit w/ChemoClave and ChemoLock Port; Spiros w/Red Cap; ChemoLock Port REF: CL4138
Hazard: Port weld of drug transfer device may separate or break during use and potentially result in a leak.
November 5, 2025Medical DevicesFDA
ICU Medical, Inc. recalls ICU Medical Oncology Kit w/ChemoLock, ChemoLock Port REF: CL4136
Hazard: Port weld of drug transfer device may separate or break during use and potentially result in a leak.
November 5, 2025Medical DevicesFDA
ICU Medical, Inc. recalls ICU Medical ChemoLock Bag Spike with Clave Additive Port REF: CL3940
Hazard: Port weld of drug transfer device may separate or break during use and potentially result in a leak.
November 5, 2025Medical DevicesFDA
ICU Medical, Inc. recalls ICU Medical Oncology Kit w/31" (79 cm) 20 Drop Admin Set w/Integrated ChemoLock" Port Drip Chamber, Spiros"; ChemoLock"
Hazard: Port weld of drug transfer device may separate or break during use and potentially result in a leak.
November 5, 2025Medical DevicesFDA
ICU Medical, Inc. recalls ICU Medical 30" (76 cm) Appx 3.6 ml, 20 Drop Admin Set w/Integrated ChemoLock Port Drip Chamber, ChemoLock w/Red Cap,
Hazard: Port weld of drug transfer device may separate or break during use and potentially result in a leak.
November 5, 2025Medical DevicesFDA
ICU Medical, Inc. recalls ICU Medical 30" (76 cm) Appx 3.3 mL, Admin Set w/20 Drop Integrated ChemoLock Drip Chamber, Spiros", Hanger, Drop-In Re
Hazard: Port weld of drug transfer device may separate or break during use and potentially result in a leak.
November 5, 2025Medical DevicesFDA
ICU Medical, Inc. recalls ICU Medical Clave Bag Spike w/ChemoLock Port REF: CL2150
Hazard: Port weld of drug transfer device may separate or break during use and potentially result in a leak.
November 5, 2025Medical DevicesFDA
ICU Medical, Inc. recalls ICU Medical ChemoLock" Port, Bulk, Non-Sterile REF: CL2100-NS
Hazard: Port weld of drug transfer device may separate or break during use and potentially result in a leak.
November 5, 2025Medical DevicesFDA
ICU Medical, Inc. recalls ICU Medical Chemo Lock Universal Vented Vial Spike REF: CL-70-10
Hazard: Port weld of drug transfer device may separate or break during use and potentially result in a leak.
November 5, 2025Medical DevicesFDA
ICU Medical, Inc. recalls ChemoLock Bag Spike, 01 units REF: CL-10-10
Hazard: Port weld of drug transfer device may separate or break during use and potentially result in a leak.
November 5, 2025Medical DevicesFDA
Canon Medical System, USA, INC. recalls VANTAGE GALAN 3T. CMSC Model: MRT-3020/U7. Model Number: MEXL-3020/B7.
Hazard: Affected system contains components that do not meet the required distance between electrodes for compliance with the IEC 60601-1 standard for medical electrical equipment.
November 5, 2025Medical DevicesFDA
Alcon Research LLC recalls Alcon PRECISION1 One-Day Contact Lenses, -2.25D.
Hazard: Potential for a weak seal in some units resulting in compromise in sterility.
November 5, 2025Medical DevicesFDA
Surgical Theater Inc recalls Surgical Planner, BrainSTORM, software version BST.9.3.0, orthopedic augmented reality
Hazard: A software anomaly, under specific conditions when large rotational alignment values are applied in 2D Image Fusion, may lead to misalignment of any secondary image layer(s) to the primary image layer.
November 5, 2025Medical DevicesFDA
Surgical Theater Inc recalls SpineAR Surgical Navigation Advanced Platform Patient Engagement (SyncAR SNAP), software version SPR.1.2.0, orthopedic a
Hazard: A software anomaly, under specific conditions when large rotational alignment values are applied in 2D Image Fusion, may lead to misalignment of any secondary image layer(s) to the primary image layer.
November 5, 2025Medical DevicesFDA
Surgical Theater Inc recalls Endo Surgical Navigation Advanced Platform Patient Engagement (EndoSNAP), software version SNP.1.12.0, imaging processin
Hazard: A software anomaly, under specific conditions when large rotational alignment values are applied in 2D Image Fusion, may lead to misalignment of any secondary image layer(s) to the primary image layer.