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ICU Medical Inc.

369 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Hotline Fluid Warming Set, single use device, is designed to warm blood and intravenous fl recall (Z-2759-2026)ICU Medical Inc.2026-07-17
ICU Medical Plum Duo Infusion Pump, v1.2.3: 1) Item Number 400020401 and 2) Item Number 40 recall (Z-2723-2026)ICU Medical, Inc.2026-07-10
ICU Medical Plum Solo Precision IV Pump, v1.0.3, Item Number 400010401; infusion pump recall (Z-2724-2026)ICU Medical, Inc.2026-07-10
Plum Solo Precision IV Pump, 40001-0401 recall (Z-2311-2026)ICU Medical, Inc.2026-06-05
Plum Duo Infusion Pump, 40002-0401 recall (Z-2312-2026)ICU Medical, Inc.2026-06-05
Plum Duo Precision IV Pump, 40002-0403 recall (Z-2313-2026)ICU Medical, Inc.2026-06-05
Oncology Kit w/60" (152 cm) Appx 2.2 ml, Smallbore Ext Set w/ChemoLock Port, Clamp, Anti-S recall (Z-2210-2026)ICU Medical, Inc.2026-05-18
Tego Connector: REF: 011-D1000, 01C-D1000, 055-D1000, D1000; Conector Tego: REF: LAT-D1000 recall (Z-1111-2026)ICU Medical, Inc.2026-01-16
ICU Medical Plum Duo Infusion Pump, List Numbers: 400020401 (US), 400021001 (Philippines) recall (Z-1118-2026)ICU Medical, Inc.2026-01-16
ICU Medical Plum Duo Precision IV Pump, List Numbers: 400020403 (US), 400021003 (Philippin recall (Z-1119-2026)ICU Medical, Inc.2026-01-16
ICU Medical Plum Solo Precision IV Pump, List Numbers: 400010401 (US), 400011001 (Philippi recall (Z-1120-2026)ICU Medical, Inc.2026-01-16
Plum Duo Infusion System, List Number 40002-04-01 recall (Z-1094-2026)ICU Medical, Inc.2026-01-15
Pulsator Arterial Blood Sampling Kit, Item Numbers 4044EG-1 4080P-2 4084P-1 4080PE 4080PG recall (Z-1100-2026)ICU Medical Inc.2026-01-15
Portex Spinal Tray, Item No. A3729-24 A3595 recall (Z-1101-2026)ICU Medical Inc.2026-01-15
LifeShield Drug Library Management (DLM); LifeShield Infusion Safety Software Suite v2.2 L recall (Z-0965-2026)ICU Medical, Inc.2025-12-19
LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software Suite v2.2 P recall (Z-0966-2026)ICU Medical, Inc.2025-12-19
ChemoLock Bag Spike, 01 units REF: CL-10-10 recall (Z-0328-2026)ICU Medical, Inc.2025-10-27
ICU Medical Chemo Lock Universal Vented Vial Spike REF: CL-70-10 recall (Z-0329-2026)ICU Medical, Inc.2025-10-27
ICU Medical ChemoLock" Port, Bulk, Non-Sterile REF: CL2100-NS recall (Z-0330-2026)ICU Medical, Inc.2025-10-27
ICU Medical Clave Bag Spike w/ChemoLock Port REF: CL2150 recall (Z-0331-2026)ICU Medical, Inc.2025-10-27
ICU Medical 30" (76 cm) Appx 3.3 mL, Admin Set w/20 Drop Integrated ChemoLock Drip Chamber recall (Z-0332-2026)ICU Medical, Inc.2025-10-27
ICU Medical 30" (76 cm) Appx 3.6 ml, 20 Drop Admin Set w/Integrated ChemoLock Port Drip Ch recall (Z-0333-2026)ICU Medical, Inc.2025-10-27
ICU Medical Oncology Kit w/31" (79 cm) 20 Drop Admin Set w/Integrated ChemoLock" Port Drip recall (Z-0334-2026)ICU Medical, Inc.2025-10-27
ICU Medical ChemoLock Bag Spike with Clave Additive Port REF: CL3940 recall (Z-0335-2026)ICU Medical, Inc.2025-10-27
ICU Medical Oncology Kit w/ChemoLock, ChemoLock Port REF: CL4136 recall (Z-0336-2026)ICU Medical, Inc.2025-10-27
ICU Medical Oncology Transfer Kit w/ChemoClave and ChemoLock Port; Spiros w/Red Cap; Chemo recall (Z-0337-2026)ICU Medical, Inc.2025-10-27
ICU Medical 45" (114 cm) Appx 1.7 ml, Smallbore Ext Set w/Spiros w/Red Cap, Anti-Siphon Va recall (Z-0338-2026)ICU Medical, Inc.2025-10-27
ICU Medical 60" (152 cm) Appx 1.2 ml, Ext Set, Smallbore w/ChemoLock Port, Clamp, Spiros w recall (Z-0339-2026)ICU Medical, Inc.2025-10-27
ICU Medical 73" (185 cm) Appx 2.5 ml, Ext Set, Smallbore w/ChemoLock Port, Clamp, ChemoLoc recall (Z-0340-2026)ICU Medical, Inc.2025-10-27
ICU Medical ChemoLock Bag Spike REF: CL-10 recall (Z-0341-2026)ICU Medical, Inc.2025-10-27
ICU Medical Double ChemoLock Port Syringe Transfer Set REF: CL-33 recall (Z-0342-2026)ICU Medical, Inc.2025-10-27
ICU Medical ChemoLock Universal Vented Vial Spike REF: CL-70 recall (Z-0343-2026)ICU Medical, Inc.2025-10-27
ICU Medical ChemoLock Vented Vial Spike, 20mm REF: CL-70S recall (Z-0344-2026)ICU Medical, Inc.2025-10-27
ICU Medical ChemoLock Vented Vial Spike, 13mm REF: CL-72 recall (Z-0345-2026)ICU Medical, Inc.2025-10-27
ICU Medical ChemoLock Closed Vial Spike REF: CL-80 recall (Z-0346-2026)ICU Medical, Inc.2025-10-27
ICU Medical ChemoLock Vial Spike, 20mm REF: CL-80S recall (Z-0347-2026)ICU Medical, Inc.2025-10-27
ICU Medical ChemoLock Closed Vial Spike w/Skirt, 5 Units REF: CL-80S-5 recall (Z-0348-2026)ICU Medical, Inc.2025-10-27
ICU Medical ChemoLock 13mm Closed Vial Spike REF: CL-82 recall (Z-0349-2026)ICU Medical, Inc.2025-10-27
ICU Medical ChemoLock Port REF: CL2100 recall (Z-0350-2026)ICU Medical, Inc.2025-10-27
ICU Medical 21" Ext Set w/ChemoLock Port, Clamp, Graduated Connector REF: CL3360 recall (Z-0351-2026)ICU Medical, Inc.2025-10-27
ICU Medical Graduated Connector w/ChemoLock Port REF: CL3900 recall (Z-0352-2026)ICU Medical, Inc.2025-10-27
ICU Medical 6.5" Bag Spike w/ChemoLock Port Additive Port, ChemoLock Port REF: CL3955 recall (Z-0353-2026)ICU Medical, Inc.2025-10-27
ICU Medical ChemoLock Vented Vial Spike, 20mm, 20 Units REF: 011-CL-70S-20 recall (Z-0354-2026)ICU Medical, Inc.2025-10-27
ICU Medical ChemoLock w/Mini Bag Spike REF: C-17 recall (Z-0355-2026)ICU Medical, Inc.2025-10-27
ICU Medical Syringe Transfer Set w/MicroClave, ChemoLock Port REF: CL-34 recall (Z-0356-2026)ICU Medical, Inc.2025-10-27
ICU Medical ChemoLock Port w/Spiros, Red Cap REF: CL-35 recall (Z-0357-2026)ICU Medical, Inc.2025-10-27
ICU Medical 8" (20 cm) Ext Set w/MicroClave Clear, ChemoLock Port, Y-Connector, Rotating L recall (Z-0358-2026)ICU Medical, Inc.2025-10-27
ICU Medical 31" (79 cm) Appx 3.4 ml, Admin Set w/20 Drop Integrated ChemoLock Drip Chamber recall (Z-0359-2026)ICU Medical, Inc.2025-10-27
ICU Medical 7.5" (19 cm) Appx 1.5 ml, Ext Set w/ChemoLock" Port, Clamp, Graduated Adapter recall (Z-0360-2026)ICU Medical, Inc.2025-10-27
ICU Medical 6" (15 cm) Ext Set w/MicroClave" Clear, ChemoLock" Port, Y-Connector, Rotating recall (Z-0361-2026)ICU Medical, Inc.2025-10-27
ICU Medical Oncology Kit w/2 ChemoLock", 13mm Closed Vial Spike w/ChemoLock" Port, ChemoLo recall (Z-0362-2026)ICU Medical, Inc.2025-10-27
ICU Medical ChemosafeLock Bag Spike REF: KL-BS001U3 recall (Z-0363-2026)ICU Medical, Inc.2025-10-27
ICU Medical ChemosafeLock Connecter REF: KL-FNU3 recall (Z-0364-2026)ICU Medical, Inc.2025-10-27
ICU Medical ChemosafeLock Vial Adapter REFs: KL-VA001U3 KL-VA002U3 KL-VA131U3 KL-VA201U3 K recall (Z-0365-2026)ICU Medical, Inc.2025-10-27
IV Administration sets. 23" (58 cm) 150 mL Burette Set (Clave, Shut Off) w/Clave, Luer Loc recall (Z-0154-2026)ICU Medical, Inc.2025-10-23
Smiths Medical CADD Medication Cassette Reservoir with clamp and female Luer. Nonvented st recall (Z-2522-2025)ICU Medical Inc.2025-09-04
Smiths Medical CADD Medication Cassette Reservoir with clamp and female Luer. Non-vented s recall (Z-2523-2025)ICU Medical Inc.2025-09-04
Smiths Medical CADD" Yellow Medication Cassette Reservoir with flow stop, clamp and female recall (Z-2524-2025)ICU Medical Inc.2025-09-04
Smiths Medical CADD" Medication Cassette Reservoir with flow stop, clamp and female Luer. recall (Z-2525-2025)ICU Medical Inc.2025-09-04
Smiths Medical CADD Medication Cassette Reservoir with flow stop, clamp and female Luer. N recall (Z-2526-2025)ICU Medical Inc.2025-09-04
Smiths Medical NRFit CADD Yellow Medication Cassette Reservoir with NRFit connector with f recall (Z-2527-2025)ICU Medical Inc.2025-09-04
Plum Duo Infusion System, List Number: 400020401 recall (Z-2129-2025)ICU Medical, Inc.2025-08-06
SwabCap Disinfecting Cap for Needlefree Connectors: SwabSleeve, REF: SCXT3-5-2000; SwabCap recall (Z-2116-2025)ICU Medical, Inc.2025-07-11
ICU Medical Plum Duo, Item numbers: 1) 400020401, 2) 400021001 , and 3) 400021003; infusio recall (Z-1990-2025)ICU Medical, Inc.2025-06-18
ICU Medical Plum Solos, Item number 400011001; infusion pump recall (Z-1991-2025)ICU Medical, Inc.2025-06-18
LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software SUite v2.1 a recall (Z-1763-2025)ICU Medical, Inc.2025-05-14
ChemoLock Close Vial Spike REF CL-80 The Chemolock Closed System Transfer Device prevents recall (Z-0652-2025)ICU Medical, Inc.2024-12-09
Allegedly counterfeit batteries manufactured by CSB batteries being used with Plum Infusio recall (Z-0482-2025)ICU Medical, Inc.2024-11-21
Replacement Battery List Number SUB0000864, found in Plum 360 Infusion System, List Number recall (Z-2447-2024)ICU Medical Inc2024-08-09
Replacement Battery List Number SUB0000594 and SUB0000864 found in Plum A+ & Plum A+3 Infu recall (Z-2448-2024)ICU Medical Inc2024-08-09
Plum 360/A+ spare batteries. Item Number: SUB0000864. recall (Z-2449-2024)ICU Medical Inc2024-08-09
Plum 360 Infusion System, List Numbers: 300100405, 300100409, 300100413, 300100414, 300100 recall (Z-2430-2023)ICU Medical Inc2023-08-18
Replacement Battery List Number SUB0000864, found in Plum 360 Infusion System, List Number recall (Z-1565-2023)ICU Medical Inc2023-05-16
Replacement Battery List Number SUB0000594 found in Plum A+ & Plum A+3 Infusion Systems, L recall (Z-1566-2023)ICU Medical Inc2023-05-16
ASM Replacement Battery, Component Number SUB0000864 recall (Z-1567-2023)ICU Medical Inc2023-05-16
ASM Replacement Battery, Component Number SUB0000594 recall (Z-1568-2023)ICU Medical Inc2023-05-16
Plum 360 Infusion System With MedNet/ Smart Card Plug And Play Module, Model # 30010. Infu recall (Z-0171-2020)ICU Medical Inc2019-10-22
icumedical ChemoClave Vented Vial Spike, 20 mm, REF CH-70S . Used in IV administration set recall (Z-1092-2019)ICU Medical, Inc.2019-04-15
icumedical ChemoClave Vented Vial Spike, 20 mm, REF CH-80S. Used in IV administration sets recall (Z-1093-2019)ICU Medical, Inc.2019-04-15
icumedical Oncology Kit w/12" Ext Set w/Spiros w/Red Cap, Clamp, Graduated Adapter; ChemoC recall (Z-1094-2019)ICU Medical, Inc.2019-04-15
icumedical Oncology Kit w/12" (30cm) Ext Set w/Spiros w/Red Cap, Clamp, Graduated Adapter; recall (Z-1095-2019)ICU Medical, Inc.2019-04-15
icumedical ChemoLock, 20mm, (a) REF CL-80S (b) REF CL-80S-10 (10 units). Used in IV admini recall (Z-1096-2019)ICU Medical, Inc.2019-04-15
icumedical ChemoLock Closed Vial Spike w/Skirt, (a) REF CL-80S-4 (4 units) (b) REF CL-80S- recall (Z-1097-2019)ICU Medical, Inc.2019-04-15
SetSource ChemoClave Vented Vial Spike, 20mm, REF Z7148. Used in IV administration sets. T recall (Z-1098-2019)ICU Medical, Inc.2019-04-15
icumedical ChemoLock Vial Spike, 20mm, REF CL-80S The ChemoLock Closed System Drug Transfe recall (Z-0805-2019)ICU Medical, Inc.2019-02-22
SURPLUG MICRO CONNECTOR Item No. 066-C3352; 111" (282 cm) Appx 13.9 ml, 15 Drop Admin Set recall (Z-0106-2018)ICU Medical, Inc.2017-11-17
18 cm (7") PUR Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, NanoClave, Rota recall (Z-2716-2017)ICU Medical, Inc.2017-06-26
168 cm (66") Appx 2.6 ml, PVC/PUR Smallbore Ext Set w/6-Port NanoClave Manifold, Check Val recall (Z-2717-2017)ICU Medical, Inc.2017-06-26
28 cm (11") PUR Bifuse Ext Set w/6-Port NanoClave Manifold, Check Valve, 2 NanoClave, Rota recall (Z-2718-2017)ICU Medical, Inc.2017-06-26
28 cm (11") PUR Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, NanoClave, Rot recall (Z-2719-2017)ICU Medical, Inc.2017-06-26
PROXIMALE - 28 cm (11") Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, NanoCl recall (Z-2720-2017)ICU Medical, Inc.2017-06-26
Kit w/3 Ext Sets, 3 Drop-In MicroClave Clear. Product Usage: The device is a single use, s recall (Z-2721-2017)ICU Medical, Inc.2017-06-26
10" Smallbore Ext Set w/6-Port NanoClave Manifold (Orange, Red, Blue, Purple, Yellow Rings recall (Z-2722-2017)ICU Medical, Inc.2017-06-26
10" Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, Clamp, Rotating Luer. Prod recall (Z-2723-2017)ICU Medical, Inc.2017-06-26
10" Smallbore Ext Set w/6-Port NanoClave Manifold (Orange, Red, Blue, Purple, Yellow Rings recall (Z-2724-2017)ICU Medical, Inc.2017-06-26
133" 60 Drop 24 Hour Primary Set w/2 Bravo24, 2 Gang 1o2 Manifold, Rotating Luer, 1 Ext, I recall (Z-0980-2017)ICU Medical, Inc.2017-01-10
Tego Connector, Item No. D1000, NM1000 The Tego Needle Free Access Device is intended for recall (Z-0988-2017)ICU Medical, Inc.2017-01-10
4 Port "ON" Manifold (600 psi) w/4 ft. Transpac IV, Item No. 46300-14NS The Transpac Dispo recall (Z-0414-2017)ICU Medical, Inc.2016-11-15
TRANSPAC IV MONITORING KIT, DISPOSABLE TRANSDUCER, 3 ML SQUEEZE FLUSH, MACRODRIP, Item No. recall (Z-0415-2017)ICU Medical, Inc.2016-11-15
Transpac IV Bifurcated Monitoring Kit 48", 2 Disposable Transducers, 2 03 ml Intraflo Flus recall (Z-0416-2017)ICU Medical, Inc.2016-11-15
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