Icu Medical, Inc.
Amanecer San Clemente, CA
This page shows every FDA and USDA recall linked to Icu Medical, Inc.. Each entry includes the product involved, when the recall happened, and how serious it was. If a company has had multiple recalls over the years, you can see the full history here in one place — including whether any were Class I, which is the most serious type.
586
Total Recalls
2006
First Recall
2026
Most Recent
Tego Connector: REF: 011-D1000, 01C-D1000, 055-D1000, D1000; Conector Tego: REF: LAT-D1000
Jan 16, 2026
· Device
Open, Classified
ICU Medical
ChemoLock" Port, Bulk, Non-Sterile
REF: CL2100-NS
Oct 27, 2025
· Device
Open, Classified
ICU Medical
ChemoLock Universal Vented Vial Spike
REF: CL-70
Oct 27, 2025
· Device
Open, Classified
ICU Medical
Oncology Transfer Kit w/ChemoClave and ChemoLock Port; Spiros w/Red Cap; ChemoLock Port
REF: CL413...
Oct 27, 2025
· Device
Open, Classified
ICU Medical
31" (79 cm) Appx 3.4 ml, Admin Set w/20 Drop Integrated ChemoLock Drip Chamber, Spiros", Purple Ca...
Oct 27, 2025
· Device
Open, Classified
ICU Medical
ChemosafeLock Bag Spike
REF: KL-BS001U3
Oct 27, 2025
· Device
Open, Classified
ICU Medical
Chemo Lock Universal Vented Vial Spike
REF: CL-70-10
Oct 27, 2025
· Device
Open, Classified
ICU Medical
Double ChemoLock Port Syringe Transfer Set
REF: CL-33
Oct 27, 2025
· Device
Open, Classified
ICU Medical
Syringe Transfer Set w/MicroClave, ChemoLock Port
REF: CL-34
Oct 27, 2025
· Device
Open, Classified
ICU Medical
Oncology Kit w/2 ChemoLock", 13mm Closed Vial Spike w/ChemoLock" Port, ChemoLock" Bag Spike, Ext S...
Oct 27, 2025
· Device
Open, Classified
ICU Medical
45" (114 cm) Appx 1.7 ml, Smallbore Ext Set w/Spiros w/Red Cap, Anti-Siphon Valve, Clamp, Y-Connec...
Oct 27, 2025
· Device
Open, Classified
ICU Medical
Graduated Connector w/ChemoLock Port
REF: CL3900
Oct 27, 2025
· Device
Open, Classified
ICU Medical
ChemoLock Bag Spike
REF: CL-10
Oct 27, 2025
· Device
Open, Classified
ICU Medical
Oncology Kit w/31" (79 cm) 20 Drop Admin Set w/Integrated ChemoLock" Port Drip Chamber, Spiros"; C...
Oct 27, 2025
· Device
Open, Classified
ICU Medical
ChemoLock Port w/Spiros, Red Cap
REF: CL-35
Oct 27, 2025
· Device
Open, Classified
ICU Medical
ChemoLock 13mm Closed Vial Spike
REF: CL-82
Oct 27, 2025
· Device
Open, Classified
ICU Medical
ChemosafeLock Connecter
REF: KL-FNU3
Oct 27, 2025
· Device
Open, Classified
ICU Medical
ChemoLock Vented Vial Spike, 13mm
REF: CL-72
Oct 27, 2025
· Device
Open, Classified
ICU Medical
ChemoLock Vented Vial Spike, 20mm, 20 Units
REF: 011-CL-70S-20
Oct 27, 2025
· Device
Open, Classified
ICU Medical
7.5" (19 cm) Appx 1.5 ml, Ext Set w/ChemoLock" Port, Clamp, Graduated Adapter
REF: CL3967
Oct 27, 2025
· Device
Open, Classified
ICU Medical
ChemoLock Bag Spike with Clave Additive Port
REF: CL3940
Oct 27, 2025
· Device
Open, Classified
ICU Medical
6" (15 cm) Ext Set w/MicroClave" Clear, ChemoLock" Port, Y-Connector, Rotating Luer
REF: CL4118
Oct 27, 2025
· Device
Open, Classified
ICU Medical
30" (76 cm) Appx 3.3 mL, Admin Set w/20 Drop Integrated ChemoLock Drip Chamber, Spiros", Hanger, D...
Oct 27, 2025
· Device
Open, Classified
ICU Medical
ChemoLock Port
REF: CL2100
Oct 27, 2025
· Device
Open, Classified
ICU Medical
6.5" Bag Spike w/ChemoLock Port Additive Port, ChemoLock Port
REF: CL3955
Oct 27, 2025
· Device
Open, Classified
ICU Medical
30" (76 cm) Appx 3.6 ml, 20 Drop Admin Set w/Integrated ChemoLock Port Drip Chamber, ChemoLock w/...
Oct 27, 2025
· Device
Open, Classified
ICU Medical
73" (185 cm) Appx 2.5 ml, Ext Set, Smallbore w/ChemoLock Port, Clamp, ChemoLock w/Red Cap
REF: CL4...
Oct 27, 2025
· Device
Open, Classified
ICU Medical
21" Ext Set w/ChemoLock Port, Clamp, Graduated Connector
REF: CL3360
Oct 27, 2025
· Device
Open, Classified
ICU Medical
8" (20 cm) Ext Set w/MicroClave Clear, ChemoLock Port, Y-Connector, Rotating Luer,
REF: CL-3950
Oct 27, 2025
· Device
Open, Classified
ICU Medical
ChemoLock w/Mini Bag Spike
REF: C-17
Oct 27, 2025
· Device
Open, Classified
ICU Medical
60" (152 cm) Appx 1.2 ml, Ext Set, Smallbore w/ChemoLock Port, Clamp, Spiros w/Red Cap
REF: CL4173
Oct 27, 2025
· Device
Open, Classified
ICU Medical
Oncology Kit w/ChemoLock, ChemoLock Port
REF: CL4136
Oct 27, 2025
· Device
Open, Classified
ICU Medical
ChemoLock Closed Vial Spike
REF: CL-80
Oct 27, 2025
· Device
Open, Classified
ICU Medical
ChemoLock Closed Vial Spike w/Skirt, 5 Units
REF: CL-80S-5
Oct 27, 2025
· Device
Open, Classified
ChemoLock Bag Spike, 01 units
REF: CL-10-10
Oct 27, 2025
· Device
Open, Classified
ICU Medical
Clave Bag Spike w/ChemoLock Port
REF: CL2150
Oct 27, 2025
· Device
Open, Classified
ICU Medical
ChemosafeLock Vial Adapter
REFs: KL-VA001U3 KL-VA002U3 KL-VA131U3 KL-VA201U3 KL-VA202U3 KL-VA321U...
Oct 27, 2025
· Device
Open, Classified
ICU Medical
ChemoLock Vial Spike, 20mm
REF: CL-80S
Oct 27, 2025
· Device
Open, Classified
ICU Medical
ChemoLock Vented Vial Spike, 20mm
REF: CL-70S
Oct 27, 2025
· Device
Open, Classified
IV Administration sets.
23" (58 cm) 150 mL Burette Set (Clave, Shut Off) w/Clave, Luer Lock, REF: B33359;
23...
Oct 23, 2025
· Device
Open, Classified
SwabCap Disinfecting Cap for Needlefree Connectors: SwabSleeve, REF: SCXT3-5-2000; SwabCap, 200-ct. Box, REF:...
Jul 11, 2025
· Device
Open, Classified
ChemoLock Close Vial Spike REF CL-80
The Chemolock Closed System Transfer Device prevents the transfer of env...
Dec 9, 2024
· Device
Open, Classified
6" (15 cm) Appx 0.85 ml, Smallbore Trifuse Ext Set w/3 MicroClave Clear, 2 Check Valve, 3 Clamps, Rotating Lue...
Aug 1, 2022
· Device
Open, Classified
6.5" (17 cm) Appx 0.84 ml, Smallbore Bifuse Ext Set w/2 MicroClave Clear, 2 Check Valves, Luer Lock;
Aug 1, 2022
· Device
Open, Classified
8.5" (22 cm) Appx 0.85 ml, Bifuse Pressure Infusion (400 psig) Ext Set w/2 Remv MicroClave Clear, 2 Purple Cla...
Aug 1, 2022
· Device
Open, Classified
MicroClave Clear Neutral Connector;
MicroClave Clear Connector;
MicroClave Clear Neutral Connector, Approx P...
Aug 1, 2022
· Device
Open, Classified
MicroClave Clear Neutral Connector. A bidirectional connector used as an accessory to an intravascular cathete...
Aug 1, 2022
· Device
Open, Classified
6.5 IN (17 cm) APPX 0.78 ml, EXT SET w/Clave CLEAR, Clave 4-WAY Stopcock, Spiros, RED CAP.
Accessory for in...
Aug 1, 2022
· Device
Open, Classified
Product Description/Item: ChemoLock Vial Spike, 20mm/011-CL-80S;
ChemoLock Bag Spike/CL-10;
ChemoLock w/Mini B...
Jun 27, 2022
· Device
Open, Classified
Product Description/Item: ChemoLock Bag Spike, 10 units/CL-10-10;
ChemoLock BAG SPIKE w/ ADDITIVE PORT, DRY SP...
Jun 27, 2022
· Device
Open, Classified