Medical device recalls
38845 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 ChemosafeLock Bag Spike REF: KL-BS001U3
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/2 ChemoLock", 13mm Closed Vial Spike w/ChemoLock" Port, ChemoLock" Bag Spike, Ext Set w/ChemoLock" Port, Clamp, Graduated Adapter REF: CL4188
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 6" (15 cm) Ext Set w/MicroClave" Clear, ChemoLock" Port, Y-Connector, Rotating Luer REF: CL4118
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 7.5" (19 cm) Appx 1.5 ml, Ext Set w/ChemoLock" Port, Clamp, Graduated Adapter REF: CL3967
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 31" (79 cm) Appx 3.4 ml, Admin Set w/20 Drop Integrated ChemoLock Drip Chamber, Spiros", Purple Cap, Hanger REF: CL3951
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 8" (20 cm) Ext Set w/MicroClave Clear, ChemoLock Port, Y-Connector, Rotating Luer, REF: CL-3950
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 w/Spiros, Red Cap REF: CL-35
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 Syringe Transfer Set w/MicroClave, ChemoLock Port REF: CL-34
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 w/Mini Bag Spike ¿ REF: C-17
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, 20 Units ¿ REF: 011-CL-70S-20
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 6.5" Bag Spike w/ChemoLock Port Additive Port, ChemoLock Port REF: CL3955
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 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.
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