ICU Medical
82 federal recalls on file, showing the 59 from the last 12 months. We monitor every CPSC, FDA, USDA, and NHTSA notice for ICU Medical and translate it into plain English — free weekly digest, optional same-day alerts.
- 2025-11-05FDA-DeviceClass 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-DeviceClass 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-DeviceClass 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-DeviceClass 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-DeviceClass 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-DeviceClass 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-DeviceClass 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-DeviceClass 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-DeviceClass 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-DeviceClass 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-DeviceClass 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-DeviceClass 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-DeviceClass 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-DeviceClass 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-DeviceClass 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-DeviceClass 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-DeviceClass 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-DeviceClass 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-DeviceClass 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-DeviceClass 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-DeviceClass 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-DeviceClass 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-DeviceClass 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-DeviceClass 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-DeviceClass 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-DeviceClass 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-DeviceClass 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-DrugClass II0.9% SODIUM CHLORIDE Injection, USP, 100 mL, Rx only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC 0990-7984-37
Lack of Assurance of Sterility: Potential for flexible container leaks.
- 2025-10-29FDA-DeviceClass IIV Administration sets. 23" (58 cm) 150 mL Burette Set (Clave, Shut Off) w/Clave, Luer Lock, REF: B33359; 23" (58 cm) 150 ml Burette Set (w/Shut Off), MicroClave, Clamp, REF: B9213; 70" (178 cm) 150 ml Burette Set (Clave, Shut-Off) w/3-Way Stopcock, Clave, Graduated Adapter, Rotating Luer, 1 Ext, REF: B9732; 80" (203 cm) Y-Type 150 ml, Burette Set (Clave, Shut-Off), w/3-Way Stopcock, Clave, Graduated Adapter, Rotating, Luer, 1 Ext, REF: B9733; 53 cm (21") Add-On 150 ml Burette Set (Clave,
IV Gravity burette administration set burette component is missing an internal shutoff valve intended to stop fluid flow, which if used may result in delay in therapy during setup, over delivery/unrestricted flow, or air may be infused into the body.
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