Open, ClassifiedPosted Oct 27, 2025·Initiated Sep 8, 2025
ICU Medical
Chemo Lock Universal Vented Vial Spike
REF: CL-70-10
Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Root cause: Under Investigation by firm
Recalling firm: ICU Medical, Inc.Type: Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer SystemDistribution: Worldwide distribution: US (Nationwide) including states of: AK AL AR AZ CA CO CT DE FL GA IA ID IL KS KY LA MA MD MI MN MS MT NC NE NJ NM NV NY OH OK OR PA SD TN TX VA WA WY and OUS (foreign) to countries of: Canada, France, and Japan.Recall #Z-0329-2026
Open, ClassifiedPosted Oct 27, 2025·Initiated Sep 8, 2025
ICU Medical
ChemoLock" Port, Bulk, Non-Sterile
REF: CL2100-NS
Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Root cause: Under Investigation by firm
Recalling firm: ICU Medical, Inc.Type: Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer SystemDistribution: Worldwide distribution: US (Nationwide) including states of: AK AL AR AZ CA CO CT DE FL GA IA ID IL KS KY LA MA MD MI MN MS MT NC NE NJ NM NV NY OH OK OR PA SD TN TX VA WA WY and OUS (foreign) to countries of: Canada, France, and Japan.Recall #Z-0330-2026
Open, ClassifiedPosted Oct 27, 2025·Initiated Sep 8, 2025
ICU Medical
Clave Bag Spike w/ChemoLock Port
REF: CL2150
Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Root cause: Under Investigation by firm
Recalling firm: ICU Medical, Inc.Type: Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer SystemDistribution: Worldwide distribution: US (Nationwide) including states of: AK AL AR AZ CA CO CT DE FL GA IA ID IL KS KY LA MA MD MI MN MS MT NC NE NJ NM NV NY OH OK OR PA SD TN TX VA WA WY and OUS (foreign) to countries of: Canada, France, and Japan.Recall #Z-0331-2026
Open, ClassifiedPosted Oct 27, 2025·Initiated Sep 8, 2025
ICU 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
Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Root cause: Under Investigation by firm
Recalling firm: ICU Medical, Inc.Type: Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer SystemDistribution: Worldwide distribution: US (Nationwide) including states of: AK AL AR AZ CA CO CT DE FL GA IA ID IL KS KY LA MA MD MI MN MS MT NC NE NJ NM NV NY OH OK OR PA SD TN TX VA WA WY and OUS (foreign) to countries of: Canada, France, and Japan.Recall #Z-0332-2026
Open, ClassifiedPosted Oct 27, 2025·Initiated Sep 8, 2025
ICU 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
Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Root cause: Under Investigation by firm
Recalling firm: ICU Medical, Inc.Type: Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer SystemDistribution: Worldwide distribution: US (Nationwide) including states of: AK AL AR AZ CA CO CT DE FL GA IA ID IL KS KY LA MA MD MI MN MS MT NC NE NJ NM NV NY OH OK OR PA SD TN TX VA WA WY and OUS (foreign) to countries of: Canada, France, and Japan.Recall #Z-0333-2026
Open, ClassifiedPosted Oct 27, 2025·Initiated Sep 8, 2025
ICU 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
Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Root cause: Under Investigation by firm
Recalling firm: ICU Medical, Inc.Type: Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer SystemDistribution: Worldwide distribution: US (Nationwide) including states of: AK AL AR AZ CA CO CT DE FL GA IA ID IL KS KY LA MA MD MI MN MS MT NC NE NJ NM NV NY OH OK OR PA SD TN TX VA WA WY and OUS (foreign) to countries of: Canada, France, and Japan.Recall #Z-0334-2026
Open, ClassifiedPosted Oct 27, 2025·Initiated Sep 8, 2025
ICU Medical
ChemoLock Bag Spike with Clave Additive Port
REF: CL3940
Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Root cause: Under Investigation by firm
Recalling firm: ICU Medical, Inc.Type: Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer SystemDistribution: Worldwide distribution: US (Nationwide) including states of: AK AL AR AZ CA CO CT DE FL GA IA ID IL KS KY LA MA MD MI MN MS MT NC NE NJ NM NV NY OH OK OR PA SD TN TX VA WA WY and OUS (foreign) to countries of: Canada, France, and Japan.Recall #Z-0335-2026
Open, ClassifiedPosted Oct 27, 2025·Initiated Sep 8, 2025
ICU Medical
Oncology Kit w/ChemoLock, ChemoLock Port
REF: CL4136
Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Root cause: Under Investigation by firm
Recalling firm: ICU Medical, Inc.Type: Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer SystemDistribution: Worldwide distribution: US (Nationwide) including states of: AK AL AR AZ CA CO CT DE FL GA IA ID IL KS KY LA MA MD MI MN MS MT NC NE NJ NM NV NY OH OK OR PA SD TN TX VA WA WY and OUS (foreign) to countries of: Canada, France, and Japan.Recall #Z-0336-2026
Open, ClassifiedPosted Oct 27, 2025·Initiated Sep 8, 2025
ICU Medical
Oncology Transfer Kit w/ChemoClave and ChemoLock Port; Spiros w/Red Cap; ChemoLock Port
REF: CL4138
Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Root cause: Under Investigation by firm
Recalling firm: ICU Medical, Inc.Type: Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer SystemDistribution: Worldwide distribution: US (Nationwide) including states of: AK AL AR AZ CA CO CT DE FL GA IA ID IL KS KY LA MA MD MI MN MS MT NC NE NJ NM NV NY OH OK OR PA SD TN TX VA WA WY and OUS (foreign) to countries of: Canada, France, and Japan.Recall #Z-0337-2026
Open, ClassifiedPosted Oct 27, 2025·Initiated Sep 8, 2025
ICU 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
Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Root cause: Under Investigation by firm
Recalling firm: ICU Medical, Inc.Type: Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer SystemDistribution: Worldwide distribution: US (Nationwide) including states of: AK AL AR AZ CA CO CT DE FL GA IA ID IL KS KY LA MA MD MI MN MS MT NC NE NJ NM NV NY OH OK OR PA SD TN TX VA WA WY and OUS (foreign) to countries of: Canada, France, and Japan.Recall #Z-0338-2026
Open, ClassifiedPosted Oct 27, 2025·Initiated Sep 8, 2025
ICU Medical
60" (152 cm) Appx 1.2 ml, Ext Set, Smallbore w/ChemoLock Port, Clamp, Spiros w/Red Cap
REF: CL4173
Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Root cause: Under Investigation by firm
Recalling firm: ICU Medical, Inc.Type: Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer SystemDistribution: Worldwide distribution: US (Nationwide) including states of: AK AL AR AZ CA CO CT DE FL GA IA ID IL KS KY LA MA MD MI MN MS MT NC NE NJ NM NV NY OH OK OR PA SD TN TX VA WA WY and OUS (foreign) to countries of: Canada, France, and Japan.Recall #Z-0339-2026
Open, ClassifiedPosted Oct 27, 2025·Initiated Sep 8, 2025
ICU Medical
73" (185 cm) Appx 2.5 ml, Ext Set, Smallbore w/ChemoLock Port, Clamp, ChemoLock w/Red Cap
REF: CL4176
Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Root cause: Under Investigation by firm
Recalling firm: ICU Medical, Inc.Type: Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer SystemDistribution: Worldwide distribution: US (Nationwide) including states of: AK AL AR AZ CA CO CT DE FL GA IA ID IL KS KY LA MA MD MI MN MS MT NC NE NJ NM NV NY OH OK OR PA SD TN TX VA WA WY and OUS (foreign) to countries of: Canada, France, and Japan.Recall #Z-0340-2026
Open, ClassifiedPosted Oct 27, 2025·Initiated Sep 8, 2025
ICU Medical
ChemoLock Bag Spike
REF: CL-10
Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Root cause: Under Investigation by firm
Recalling firm: ICU Medical, Inc.Type: Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer SystemDistribution: Worldwide distribution: US (Nationwide) including states of: AK AL AR AZ CA CO CT DE FL GA IA ID IL KS KY LA MA MD MI MN MS MT NC NE NJ NM NV NY OH OK OR PA SD TN TX VA WA WY and OUS (foreign) to countries of: Canada, France, and Japan.Recall #Z-0341-2026
Open, ClassifiedPosted Oct 27, 2025·Initiated Sep 8, 2025
ICU Medical
Double ChemoLock Port Syringe Transfer Set
REF: CL-33
Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Root cause: Under Investigation by firm
Recalling firm: ICU Medical, Inc.Type: Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer SystemDistribution: Worldwide distribution: US (Nationwide) including states of: AK AL AR AZ CA CO CT DE FL GA IA ID IL KS KY LA MA MD MI MN MS MT NC NE NJ NM NV NY OH OK OR PA SD TN TX VA WA WY and OUS (foreign) to countries of: Canada, France, and Japan.Recall #Z-0342-2026
Open, ClassifiedPosted Oct 27, 2025·Initiated Sep 8, 2025
ICU Medical
ChemoLock Universal Vented Vial Spike
REF: CL-70
Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Root cause: Under Investigation by firm
Recalling firm: ICU Medical, Inc.Type: Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer SystemDistribution: Worldwide distribution: US (Nationwide) including states of: AK AL AR AZ CA CO CT DE FL GA IA ID IL KS KY LA MA MD MI MN MS MT NC NE NJ NM NV NY OH OK OR PA SD TN TX VA WA WY and OUS (foreign) to countries of: Canada, France, and Japan.Recall #Z-0343-2026
Open, ClassifiedPosted Oct 27, 2025·Initiated Sep 8, 2025
ICU Medical
ChemoLock Vented Vial Spike, 20mm
REF: CL-70S
Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Root cause: Under Investigation by firm
Recalling firm: ICU Medical, Inc.Type: Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer SystemDistribution: Worldwide distribution: US (Nationwide) including states of: AK AL AR AZ CA CO CT DE FL GA IA ID IL KS KY LA MA MD MI MN MS MT NC NE NJ NM NV NY OH OK OR PA SD TN TX VA WA WY and OUS (foreign) to countries of: Canada, France, and Japan.Recall #Z-0344-2026
Open, ClassifiedPosted Oct 27, 2025·Initiated Sep 8, 2025
ICU Medical
ChemoLock Vented Vial Spike, 13mm
REF: CL-72
Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Root cause: Under Investigation by firm
Recalling firm: ICU Medical, Inc.Type: Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer SystemDistribution: Worldwide distribution: US (Nationwide) including states of: AK AL AR AZ CA CO CT DE FL GA IA ID IL KS KY LA MA MD MI MN MS MT NC NE NJ NM NV NY OH OK OR PA SD TN TX VA WA WY and OUS (foreign) to countries of: Canada, France, and Japan.Recall #Z-0345-2026
Open, ClassifiedPosted Oct 27, 2025·Initiated Sep 8, 2025
ICU Medical
ChemoLock Closed Vial Spike
REF: CL-80
Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Root cause: Under Investigation by firm
Recalling firm: ICU Medical, Inc.Type: Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer SystemDistribution: Worldwide distribution: US (Nationwide) including states of: AK AL AR AZ CA CO CT DE FL GA IA ID IL KS KY LA MA MD MI MN MS MT NC NE NJ NM NV NY OH OK OR PA SD TN TX VA WA WY and OUS (foreign) to countries of: Canada, France, and Japan.Recall #Z-0346-2026
Open, ClassifiedPosted Oct 27, 2025·Initiated Sep 8, 2025
ICU Medical
ChemoLock Vial Spike, 20mm
REF: CL-80S
Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Root cause: Under Investigation by firm
Recalling firm: ICU Medical, Inc.Type: Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer SystemDistribution: Worldwide distribution: US (Nationwide) including states of: AK AL AR AZ CA CO CT DE FL GA IA ID IL KS KY LA MA MD MI MN MS MT NC NE NJ NM NV NY OH OK OR PA SD TN TX VA WA WY and OUS (foreign) to countries of: Canada, France, and Japan.Recall #Z-0347-2026
Open, ClassifiedPosted Oct 27, 2025·Initiated Sep 8, 2025
ICU Medical
ChemoLock Closed Vial Spike w/Skirt, 5 Units
REF: CL-80S-5
Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Root cause: Under Investigation by firm
Recalling firm: ICU Medical, Inc.Type: Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer SystemDistribution: Worldwide distribution: US (Nationwide) including states of: AK AL AR AZ CA CO CT DE FL GA IA ID IL KS KY LA MA MD MI MN MS MT NC NE NJ NM NV NY OH OK OR PA SD TN TX VA WA WY and OUS (foreign) to countries of: Canada, France, and Japan.Recall #Z-0348-2026