Medical device recalls
38684 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2025-11-05FDA-DeviceICU Medical, Inc.Class IIICU Medical Graduated Connector w/ChemoLock Port REF: CL3900
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
- 2025-11-05FDA-DeviceICU Medical, Inc.Class IIICU Medical 21" Ext Set w/ChemoLock Port, Clamp, Graduated Connector REF: CL3360
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
- 2025-11-05FDA-DeviceICU Medical, Inc.Class IIICU Medical ChemoLock Port REF: CL2100
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
- 2025-11-05FDA-DeviceICU Medical, Inc.Class IIICU Medical ChemoLock 13mm Closed Vial Spike REF: CL-82
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
- 2025-11-05FDA-DeviceICU Medical, Inc.Class IIICU Medical ChemoLock Closed Vial Spike w/Skirt, 5 Units REF: CL-80S-5
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
- 2025-11-05FDA-DeviceICU Medical, Inc.Class IIICU Medical ChemoLock Vial Spike, 20mm REF: CL-80S
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
- 2025-11-05FDA-DeviceICU Medical, Inc.Class IIICU Medical ChemoLock Closed Vial Spike REF: CL-80
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
- 2025-11-05FDA-DeviceICU Medical, Inc.Class IIICU Medical ChemoLock Vented Vial Spike, 13mm REF: CL-72
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
- 2025-11-05FDA-DeviceICU Medical, Inc.Class IIICU Medical ChemoLock Vented Vial Spike, 20mm REF: CL-70S
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
- 2025-11-05FDA-DeviceICU Medical, Inc.Class IIICU Medical ChemoLock Universal Vented Vial Spike REF: CL-70
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
- 2025-11-05FDA-DeviceICU Medical, Inc.Class IIICU Medical Double ChemoLock Port Syringe Transfer Set REF: CL-33
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
- 2025-11-05FDA-DeviceICU Medical, Inc.Class IIICU Medical ChemoLock Bag Spike REF: CL-10
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
- 2025-11-05FDA-DeviceICU Medical, Inc.Class IIICU Medical 73" (185 cm) Appx 2.5 ml, Ext Set, Smallbore w/ChemoLock Port, Clamp, ChemoLock w/Red Cap REF: CL4176
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
- 2025-11-05FDA-DeviceICU Medical, Inc.Class IIICU Medical 60" (152 cm) Appx 1.2 ml, Ext Set, Smallbore w/ChemoLock Port, Clamp, Spiros w/Red Cap REF: CL4173
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
- 2025-11-05FDA-DeviceICU Medical, Inc.Class IIICU Medical 45" (114 cm) Appx 1.7 ml, Smallbore Ext Set w/Spiros w/Red Cap, Anti-Siphon Valve, Clamp, Y-Connector w/ChemoLock Port, Rotating Luer REF: CL4151
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
- 2025-11-05FDA-DeviceICU Medical, Inc.Class IIICU Medical Oncology Transfer Kit w/ChemoClave and ChemoLock Port; Spiros w/Red Cap; ChemoLock Port REF: CL4138
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
- 2025-11-05FDA-DeviceICU Medical, Inc.Class IIICU Medical Oncology Kit w/ChemoLock, ChemoLock Port REF: CL4136
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
- 2025-11-05FDA-DeviceICU Medical, Inc.Class IIICU Medical ChemoLock Bag Spike with Clave Additive Port REF: CL3940
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
- 2025-11-05FDA-DeviceICU Medical, Inc.Class IIICU Medical Oncology Kit w/31" (79 cm) 20 Drop Admin Set w/Integrated ChemoLock" Port Drip Chamber, Spiros"; ChemoLock"; ChemoLock" Universal Vented Vial Spike; Bag Hanger REF: CL3929
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
- 2025-11-05FDA-DeviceICU Medical, Inc.Class IIICU Medical 30" (76 cm) Appx 3.6 ml, 20 Drop Admin Set w/Integrated ChemoLock Port Drip Chamber, ChemoLock w/Red Cap, Bag Hanger REF: CL3511
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
- 2025-11-05FDA-DeviceICU Medical, Inc.Class IIICU Medical 30" (76 cm) Appx 3.3 mL, Admin Set w/20 Drop Integrated ChemoLock Drip Chamber, Spiros", Hanger, Drop-In Red Cap REF: CL3011
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
- 2025-11-05FDA-DeviceICU Medical, Inc.Class IIICU Medical Clave Bag Spike w/ChemoLock Port REF: CL2150
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
- 2025-11-05FDA-DeviceICU Medical, Inc.Class IIICU Medical ChemoLock" Port, Bulk, Non-Sterile REF: CL2100-NS
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
- 2025-11-05FDA-DeviceICU Medical, Inc.Class IIICU Medical Chemo Lock Universal Vented Vial Spike REF: CL-70-10
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
- 2025-11-05FDA-DeviceICU Medical, Inc.Class IIChemoLock Bag Spike, 01 units REF: CL-10-10
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
- 2025-11-05FDA-DeviceCanon Medical System, USA, INC.Class IIVANTAGE GALAN 3T. CMSC Model: MRT-3020/U7. Model Number: MEXL-3020/B7.
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.
- 2025-11-05FDA-DeviceAlcon Research LLCClass IIAlcon PRECISION1 One-Day Contact Lenses, -2.25D.
Potential for a weak seal in some units resulting in compromise in sterility.
- 2025-11-05FDA-DeviceSurgical Theater IncClass IISurgical Planner, BrainSTORM, software version BST.9.3.0, orthopedic augmented reality
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.
- 2025-11-05FDA-DeviceSurgical Theater IncClass IISpineAR Surgical Navigation Advanced Platform Patient Engagement (SyncAR SNAP), software version SPR.1.2.0, orthopedic augmented reality
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.
- 2025-11-05FDA-DeviceSurgical Theater IncClass IIEndo Surgical Navigation Advanced Platform Patient Engagement (EndoSNAP), software version SNP.1.12.0, imaging processing radiological system
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.
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