ICU Medical, Inc. recalls
Every recall we track for ICU Medical, Inc. — 376 in all, from 2017–2026 — plus the complaints and injury reports the public filed about them. 27 are rated “stop using now”.
Recalls per year, by danger level
Recalls from ICU Medical, Inc. more than tripled in 2025 (61, up from 5 in 2024). 7% rated “stop using now”.
All FDA recall records for ICU Medical, Inc. since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 1 | 3 | 53 | 1 | 58 |
| 2018 | 1 | 8 | 10 | 4 | 23 |
| 2019 | 10 | 12 | 20 | 2 | 44 |
| 2020 | 3 | 58 | 60 | 6 | 127 |
| 2021 | 1 | 5 | 22 | 0 | 28 |
| 2022 | 0 | 5 | 4 | 0 | 9 |
| 2023 | 0 | 1 | 4 | 0 | 5 |
| 2024 | 0 | 1 | 4 | 0 | 5 |
| 2025 | 11 | 28 | 22 | 0 | 61 |
| 2026 (to date) | 0 | 6 | 10 | 0 | 16 |
Most common reasons for ICU Medical, Inc. recalls
What to do if you have a recalled ICU Medical, Inc. product
- Match the model, catalog or lot number on your device to the recall.
- Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals.
- Report problems to FDA MedWatch.
All ICU Medical, Inc. recalls
60 shown- Use cautionMedical device
ICU Medical, Inc. recalls CADD Yellow Medication Cassette Reservoir with NRFit connector US Product Codes: 21-7600-24, 21-7609-24 OUS Product
ICU Medical recalls CADD Yellow Medication Cassette Reservoirs with NRFit connector due to potential medication leakage at the joint, which could cause therapy delays, medication exposure, or air embolus.
ICU MedicalAug 20, 2026 - Use cautionMedical device
ICU Medical Inc. recalls Hotline Fluid Warming Set, single use device, is designed to warm blood and intravenous fluids and deliver them to the
ICU Medical recalls specific lots of Hotline Fluid Warming Sets due to potential leakage. Affected units may cause fluid leaks during medical use. Contact for details.
ICU MedicalJun 24, 2026 - Lower riskMedical device
ICU Medical, Inc. recalls ICU Medical Plum Duo Infusion Pump, v1.2.3: 1) Item Number 400020401 and 2) Item Number 400020403; infusion pump
ICU Medical is a leading manufacturer of medical equipment and devices, specializing in critical care solutions for hospitals and healthcare facilities.
ICU MedicalJun 10, 2026 - Lower riskMedical device
ICU Medical, Inc. recalls IV Sets with drip chambers
ICU Medical recalls IV sets with drip chambers made on or before July 4, 2026, due to potential black specks from plastic molding. Discard or return affected units to avoid risks.
ICU MedicalMay 12, 2026 - Use cautionMedical device
ICU Medical, Inc. recalls Plum Duo Precision IV Pump, 40002-0403
ICU Medical recalls Plum Duo Precision IV Pumps (40002-0403) due to potential under- or over-delivery of medications. Affected units may not alert clinicians of soft limit violations.
ICU MedicalApr 29, 2026 - Use cautionMedical device
ICU Medical, Inc. recalls Oncology Kit w/60" (152 cm) Appx 2.2 ml, Smallbore Ext Set w/ChemoLock Port, Clamp, Anti-Siphon Valve, Spiros;
ICU Medical recalls oncology kits with potential leaks during chemotherapy that could interrupt treatment and expose patients to hazardous substances. Affected kits include specific models and lots; contact for remedy.
ICU MedicalMar 24, 2026 - Lower riskMedical device
ICU Medical Inc. recalls Pulsator Arterial Blood Sampling Kit, Item Numbers 4044EG-1 4080P-2 4084P-1 4080PE 4080PG
ICU Medical recalls specific Pulsator Arterial Blood Sampling Kits with possible cracks in syringe collars that could cause blood leakage or repeated blood draws during arterial sampling.
ICU MedicalDec 19, 2025 - Use cautionMedical device
ICU Medical, Inc. recalls Tego Connector: REF: 011-D1000, 01C-D1000, 055-D1000, D1000; Conector Tego: REF: LAT-D1000
ICU Medical recalls Tego Connectors with specific model numbers due to risk of silicone seal bulging, tearing, leading to fluid leaks, blood product injection issues, or exposure to contaminants during hemodialysis.
TegoDec 19, 2025 - Use cautionMedical device
ICU Medical, Inc. recalls Plum Duo Infusion System, List Number 40002-04-01
ICU Medical recalls a specific lot of Plum Duo Infusion Systems that may fail to produce audible alarms, potentially causing missed alerts during medical use. Affected units have unique serial numbers listed in the recall notice.
ICU MedicalDec 15, 2025 - Lower riskMedical device
ICU Medical, Inc. recalls ICU Medical Plum Duo Infusion Pump, List Numbers: 400020401 (US), 400021001 (Philippines)
ICU Medical recalls Plum Duo Infusion Pumps with specific list numbers and software versions due to potential flush errors during piggyback therapy that may prevent treatment. Affected units must be checked for error messages.
ICU MedicalDec 15, 2025 - Lower riskMedical device
ICU Medical, Inc. recalls LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software Suite v2.2 Product No. 17003-02
ICU Medical recalls LifeShield Drug Library Management software v2.2 due to concentration limit precision error. This may cause incorrect drug dosing if users adjust limits beyond manufacturer recommendations.
ICU MedicalNov 24, 2025 - Lower riskMedical device
ICU Medical, Inc. recalls LifeShield Drug Library Management (DLM); LifeShield Infusion Safety Software Suite v2.2 List Number 17003-02
ICU Medical recalls LifeShield Drug Library Management v2.2.1 for migration issues that may cause infusion pump delivery errors. Affected users must use alternate methods to review changes after migration.
ICU MedicalNov 24, 2025 - Use cautionMedical device
ICU Medical, Inc. recalls IV Administration sets. 23" (58 cm) 150 mL Burette Set (Clave, Shut Off) w/Clave, Luer Lock, REF: B33359; 23" (58 cm)
ICU Medical recalls 23" 150 mL IV burette sets with missing shutoff valve that could lead to over delivery or air infusion. Affected units include specific model numbers and serial ranges.
ICU MedicalOct 2, 2025 - Stop using nowMedical device
ICU Medical, Inc. recalls ICU Medical ChemoLock Closed Vial Spike w/Skirt, 5 Units REF: CL-80S-5
ICU Medical recalls ChemoLock Closed Vial Spikes with potential port weld leaks. Affected units have specific UDI and lot numbers. Stop using immediately to prevent leaks.
ICU MedicalSep 8, 2025 - Lower riskMedical device
ICU Medical Inc. recalls Smiths Medical CADD Medication Cassette Reservoir with clamp and female Luer. Nonvented stopper included. 50mL, Product
Smiths Medical recalls 50mL medication cassette reservoirs with weakened welds that could cause medication leakage. Affected units include specific lot numbers and product codes.
Smiths MedicalAug 6, 2025 - Lower riskMedical device
ICU Medical, Inc. recalls Plum Duo Infusion System, List Number: 400020401
ICU Medical, Inc. is a leading manufacturer of medical devices and equipment. We provide innovative solutions for healthcare professionals.
ICU Medical, Inc.Jul 11, 2025 - Lower riskMedical device
ICU Medical, Inc. recalls SwabCap Disinfecting Cap for Needlefree Connectors: SwabSleeve, REF: SCXT3-5-2000; SwabCap, 200-ct. Box, REF: SCXT3-2000
ICU Medical recalls SwabCap disinfecting caps for needle-free connectors due to potential incomplete seals causing alcohol evaporation and inadequate disinfection. Affected products include SwabSleeve and 200-count boxes with specific reference numbers.
ICU MedicalJun 3, 2025 - Use cautionMedical device
ICU Medical, Inc. recalls LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software SUite v2.1 and v2.2
ICU Medical recalls LifeShield Drug Library Management software versions v2.1 and v2.2 due to potential over-delivery of drugs or incorrect therapy parameters. Affected users should contact for remedy.
ICU MedicalMay 2, 2025 - Use cautionMedical device
ICU Medical, Inc. recalls ICU Medical Plum Solos, Item number 400011001; infusion pump
ICU Medical recalls Plum Solos infusion pumps with software version 1.1.1 that may bypass maximum dose limits, risking overdose. Affected units have specific serial numbers.
ICU MedicalApr 22, 2025 - Lower riskDrug
ICU Medical, Inc. recalls POTASSIUM CHLORIDE Inj., 10 mEq total in 100 mL, 100 mEq/L flexible container, Rx Only, ICU Medical, Inc., Lake Forest,
ICU Medical recalls Potassium Chloride Inj 10 mEq due to label error indicating it may contain 20 mEq units. This could lead to incorrect dosing if used without verification.
ICU MedicalFeb 13, 2025 - Lower riskMedical device
ICU Medical, Inc. recalls ChemoLock Close Vial Spike REF CL-80 The Chemolock Closed System Transfer Device prevents the transfer of environmental
ICU Medical recalls ChemoLock Close Vial Spike REF CL-:80 due to incorrect packaging and labeling. This may cause confusion in healthcare settings. Affected units have specific lot numbers and model details.
ICU MedicalNov 6, 2024 - Use cautionMedical device
ICU Medical, Inc. recalls Allegedly counterfeit batteries manufactured by CSB batteries being used with Plum Infusion Systems: Plum 360" Infusion
ICU Medical recalls counterfeit batteries used with Plum Infusion Systems that may fail to hold charge, causing early battery replacement messages. Affected units lack ICU Medical Test Label and CE Mark.
ICU MedicalOct 22, 2024 - Lower riskMedical device
ICU Medical Inc recalls Replacement Battery List Number SUB0000594 and SUB0000864 found in Plum A+ & Plum A+3 Infusion Systems, Pump List
ICU Medical, Inc. is a medical device manufacturer that provides UDI (Unique Device Identification) information for their products. This page shows the UDI information for their devices, including product codes and serial numbers.
ICU Medical, Inc.May 7, 2024 - Use cautionMedical device
ICU Medical Inc recalls Plum 360 Infusion System, List Numbers: 300100405, 300100409, 300100413, 300100414, 300100415, 300100418, 300100451,
ICU Medical recalls Plum 360 Infusion Systems with list numbers 300100405-300109913 manufactured July 2020-Dec 2021 due to potential alarm signal failure. Consumers should contact for details.
ICU MedicalJul 13, 2023 - Lower riskMedical device
ICU Medical Inc recalls Replacement Battery List Number SUB0000864, found in Plum 360 Infusion System, List Number 30010
ICU Medical recalls Plum 360 Infusion System batteries with list number SUB0000864 that may lose capacity earlier than expected. Affected units have CSB BATTERY with first two characters 22 or lower.
ICU MedicalMar 22, 2023 - Use cautionDrug
ICU Medical Inc recalls 0.9% Sodium Chloride Injection, USP, 100 mL flexible container bag, Rx Only, ICU Medical, Inc., Lake Forest, Illinois,
ICU Medical recalls 100mL 0.9% Sodium Chloride Injection bags due to potential leakage compromising sterility. Affected lots expire MAR 2024.
ICU MedicalNov 9, 2022 - Use cautionMedical device
ICU Medical, Inc. recalls 6.5 IN (17 cm) APPX 0.78 ml, EXT SET w/Clave CLEAR, Clave 4-WAY Stopcock, Spiros, RED CAP. Accessory for intravascular
ICU Medical recalls a specific intravascular administration set due to a visible gap between connector housings that could lead to disconnections during use.
ICU MedicalAug 1, 2022 - Use cautionMedical device
ICU Medical, Inc. recalls Product Description/Item: ChemoLock Bag Spike, 10 units/CL-10-10; ChemoLock BAG SPIKE w/ ADDITIVE PORT, DRY
ICU Medical recalls ChemoLock Bag Spikes due to potential unintended disconnection, which may delay therapy and cause exposure to caustic substances. Affected items include various models with specific lot numbers.
ICU MedicalJun 27, 2022 - Stop using nowDrug
ICU Medical Inc recalls AMINOSYN II 15% An Amino Acid Injection, Sulfite-Free, 2000 mL in flexible containers, Rx ONLY, Hospira, Inc., Lake
ICU Medical recalls AMINOSYN II 15% amino acid injection due to particulate matter found in samples. This could cause serious issues for patients receiving the injection.
ICU MedicalSep 3, 2021 - Lower riskMedical device
ICU Medical, Inc. recalls REF CL3946 Oncology Kit w/5" (13 cm) Add-On Set w/ChemoLock Additive Port, Vented Cap; ChemoLock , Spinning Spiros
ICU Medical recalls specific oncology kits due to potential leakage in certain lots of Sprios male luer fittings. This could lead to fluid leakage during patient administration. Affected kits have lot number 5142959.
ICU MedicalMar 16, 2021 - Use cautionDrug
ICU Medical Inc recalls 0.9% SODIUM CHLORIDE Irrigation, USP 1000 mL Semi-Rigid Bottle, Rx only, Manufactured for ICU Medical, Inc., Lake
ICU Medical recalls 0.9% Sodium Chloride Irrigation bottles due to confirmed particulate matter in some units. Affected lots expire April 2023; check NDC 0990-7138-09 for details.
ICU MedicalMar 9, 2021 - Lower riskMedical device
ICU Medical, Inc. recalls 60" (152 cm) Appx 1.9 ml, Smallbore Ext Set w/MicroClave¿ Clear, 1.2 Micron Filter, 2 Clamps, Luer Lock REF MC330174 -
ICU Medical recalls 60" smallbore IV sets with incorrect 1.2 micron filter assembly. This could lead to improper fluid filtration during medical use. Affected units have model MC330174 and lot number 4799374.
ICU MedicalDec 2, 2020 - Lower riskMedical device
ICU Medical, Inc. recalls icumedical Cogent" Hemodynamic Monitoring System - Product Usage: intended for patients for whom the monitoring of
ICU Medical recalls Cogent Hemodynamic Monitoring System due to potential software issue causing incorrect continuous cardiac output readings after PulseCO calibration. Affected units may display wrong cardiac output values.
ICU MedicalNov 9, 2020 - Use cautionMedical device
ICU Medical, Inc. recalls 30" (76 cm) Appx 3.3 ml, 20 Drop Admin Set w/Integrated ChemoLock Drip Chamber, Spiros w/Red Cap, Hanger, REF: CL3011;
ICU Medical recalls specific IV sets with potential spinning luer leaks causing fluid contamination, exposure to hazardous medications, or blood loss. Affected models include CL3011 and others listed in the recall notice.
ICU MedicalAug 31, 2020 - Lower riskMedical device
ICU Medical, Inc. recalls APPX 0.75ml, 6-Port NanoClave Manifold (Glow, Red, Blue, Purple, Yellow Rings)BCV. 1 unit per pouch, 50 pouches per
ICU Medical recalls 50 pouches of 0.75ml 6-Port NanoClave Manifolds due to potential seal failure with spikes. Affected units may not seal properly, risking infection during medical fluid administration.
ICU MedicalJul 6, 2020 - Use cautionMedical device
ICU Medical, Inc. recalls REF MC330209 6' (15 cm) Appx 0.09 ml, Smallbore Trifuse Ext Set w/3 MicroClave Clear, 0.2 Micron Filter, 1.2 Micron
ICU Medical recalls specific IV sets with incorrect 0.2 micron filters that may cause infections during medical use. Affected units include model MC330209 with lot numbers 4447222, 4536285, 4572773, 4603405.
ICU MedicalJul 1, 2020 - Stop using nowDrug
ICU Medical Inc recalls LACTATED RINGER'S Injection, USP 1000 mL flexible container, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC
ICU Medical recalls Lactated Ringer's 1000mL injection due to iron oxide particles found in some units. Affected lots expire July 2021. No remedy specified in recall notice.
ICU MedicalMay 8, 2020 - Lower riskMedical device
ICU Medical, Inc. recalls The Cogent Hemodynamic Monitoring System. REF58400-000, GTIN 00840619099459; REF 58400-000R, GTIN 0087709094314; REF
ICU Medical recalls Cogent Hemodynamic Monitoring System with software issues causing patient ID and information not to be stored. Affected units include specific model numbers and software versions.
ICU MedicalFeb 14, 2020 - Lower riskMedical device
ICU Medical, Inc. recalls Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right
ICU Medical recalls certain central venous catheters due to guidewire not passing through needles, which may affect hemodynamic monitoring. Affected units have specific model and lot numbers.
ICU MedicalJan 2, 2020 - Stop using nowDrug
ICU Medical Inc recalls 0.9% SODIUM CHLORIDE INJECTION, USP, 250 mL VisIV Container, Rx Only, Hospira, Inc. Lake Forest, IL 60045. NDC
ICU Medical recalls 250mL 0.9% Sodium Chloride Injection (NDC 0409-7983-25) due to particulate matter risk. Affected lots expire May 2020.
ICU MedicalOct 25, 2019 - Stop using nowMedical device
ICU Medical, Inc. recalls REF: Z2812, 121" 10 Drop Primary Set w/5 MicroClave, Remv 2 Gang 4-Way Stopcocks, Rotating Luer, 2 Ext, Sterile R, UDI:
ICU Medical recalls 10-drop IV sets with potential 15-drop cannula causing under-delivery of critical medication. Affected units include specific lot numbers and model REF: Z2812. Stop using immediately to prevent serious health risks.
ICU MedicalOct 4, 2019 - Lower riskMedical device
ICU Medical Inc recalls Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as Primary
ICU Medical recalls Plum Microbore Infusion Sets with Inline Filters labeled as Primary due to potential fluid leakage from air vents. Affected units have specific product codes and lot numbers. Consumers should check their units and contact the company for details.
ICU MedicalJul 29, 2019 - Lower riskMedical device
ICU Medical, Inc. recalls ICU Medical Cogent Hemodynamic Monitoring System, Cogent Item Number 58400-000, UDI: (01)00840619079499
ICU Medical recalls Cogent Hemodynamic Monitoring System with software issues that may cause inaccurate readings, unit shutdowns, or loss of secondary parameter display. Affected units include specific serial numbers and software versions.
ICU MedicalJul 12, 2019 - Lower riskMedical device
ICU Medical, Inc. recalls icumedical ChemoLock Closed Vial Spike w/Skirt, (a) REF CL-80S-4 (4 units) (b) REF CL-80S-5 (5 units). Used in IV
ICU Medical recalls 9 units of ChemoLock Closed Vial Spikes with potential plastic burr particulate from protective caps. Stop using if you have specific lot numbers listed.
ICU MedicalFeb 21, 2019 - UnratedDrug
ICU Medical Inc recalls 0.9% Sodium Chloride Injection, USP 1000 mL flexible container, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC
ICU Medical recalls 0.9% Sodium Chloride Injection, USP 1000 mL flexible container due to CGMP deviations. This product is for prescription use only and may be unsafe for medical administration.
ICU MedicalFeb 4, 2019 - Lower riskMedical device
ICU Medical, Inc. recalls icumedical ChemoLock Vial Spike, 20mm, REF CL-80S The ChemoLock Closed System Drug Transfer Device prevents the
ICU Medical recalls ChemoLock Vial Spikes (REF CL-80S) due to potential burr particulate in one lot. Affected units may pose a risk of contamination during drug transfers.
ICU MedicalJan 3, 2019 - Use cautionMedical device
ICU Medical, Inc. recalls ICU Medical, Transpac IV Monitoring Kit With Safeset Reservoir and Blood Sampling Port, 152 cm (60") Tubing, Disposable
ICU Medical recalls Transpac IV Monitoring Kit with Safeset Reservoir and Blood Sampling Port due to risk of pressure tubing separation causing delayed therapy or blood loss, air embolism, or contamination.
ICU MedicalNov 27, 2018 - Lower riskMedical device
ICU Medical Inc recalls SAPPHIRE Epidural Set Yellow-Striped Microbore, 0.2 Micron Filter, PAV, 123 Inch, List Number 16373-02 Sapphire
ICU Medical recalls Yellow-Striped Microbore Epidural Sets with 0.2 micron filters due to reported distal occlusion alarms during use. Affected units may have distal occlusion alarms.
ICU MedicalNov 8, 2018 - Lower riskDrug
ICU Medical Inc recalls 0.9% Sodium Chloride Injection, USP Rx Only a) 250 mL NDC 0409-7983-02; b) 150 mL NDC 0409-7983-61; c) 50 mL NDC
ICU Medical recalls 250mL, 150mL, and 50mL 0.9% Sodium Chloride injections due to potential leakage risks. These products may cause infections if not sterile.
ICU MedicalOct 8, 2018 - Lower riskMedical device
ICU Medical, Inc. recalls Iced Thermoset Closed-Loop Injectate Delivery System for cold Injectate. 1 unit per Cavity #2-4"x9" Cav/20 pieces per
ICU Medical recalls 1 unit per cavity of Iced Thermoset Closed-Loop Injectate Delivery System for cold injectate due to potential leakage from a defective thermoset check valve. Affected units have specific lot numbers and expiration dates.
ICU MedicalOct 5, 2018 - Lower riskMedical device
ICU Medical, Inc. recalls ICU Medical 14" (36 cm) Appx 3.6 ml, Bifuse Transfer Set w/Rotating Luer, REF: 14237-28 The Intravascular
ICU Medical recalls 14" Bifuse Transfer Sets (REF: 14237-28) due to missing blood filter. Use as blood transfusion set without filter risks infection. Affected units sold in specific lots.
ICU MedicalAug 20, 2018 - Use cautionMedical device
ICU Medical Inc recalls Plum 360 Infusion System With MedNet/ Smart Card Plug And Play Module, Model # 30010. Infusion pump.
ICU Medical recalls Plum 360 Infusion Systems with specific software versions when used with MedNet Custom Drug Libraries, which can become inoperable and show a blank screen.
ICU MedicalAug 1, 2018 - Use cautionDrug
ICU Medical Inc recalls 0.9% Sodium Chloride Injection, USP, 250 mL bag, Rx Only, Hospira, Inc. Lake Forest, IL 60045, NDC 0409-7983-02
ICU Medical recalls 250mL 0.9% Sodium Chloride Injection bags due to potential leaks. This could compromise sterility and pose infection risks. Check your product details to see if affected.
ICU MedicalMay 31, 2018 - Lower riskMedical device
ICU Medical, Inc. recalls 6.5" (17 cm) Smallbore Ext Set w/Remv MicroClave¿ Clear, NanoClave¿ T-Connector, Clamp, Rotating Luer, Bulk
ICU Medical recalls 6.5" smallbore infusion sets with incorrect spin collars. These devices may cause improper connections during medical use. Affected units include specific lot numbers and model A1009-NS.
ICU MedicalFeb 5, 2018 - Use cautionMedical device
ICU Medical, Inc. recalls Hemodynamic monitoring system (HMS), comprised of a Patient Interface Module (Part Number 58401-000 and a User
ICU Medical recalls hemodynamic monitoring systems with Patient Interface Module (58401-000) and User Interface Module (58403-000) that may continue thermal coil activity when paused, potentially causing overheating.
ICU MedicalJan 5, 2018 - Use cautionMedical device
ICU Medical Inc recalls Plum 360 Infusion System, List number 30010.
ICU Medical recalls Plum 360 Infusion Systems with software v15.10.00.010 due to potential pump lockout during alarms and unresponsive device after 1,500 hours of use.
ICU MedicalOct 30, 2017 - UnratedMedical device
ICU Medical Inc recalls ICU Mednet(TM) Medication Management Suite 6.1 and 6.21, Product Code/List Numbers: (a) 16037-64-01; MedNet 6.1 b)
ICU Medical recalls Medication Management Suite 6.1 and 6.21 software due to potential changes to piggyback medication settings without user notice, which could affect infusion safety.
ICU MedicalOct 30, 2017 - Use cautionMedical device
ICU Medical, Inc. recalls SURPLUG MICRO CONNECTOR Item No. 066-C3352; 111" (282 cm) Appx 13.9 ml, 15 Drop Admin Set w/3-Way Stopcock, 1 Ext, Luer
ICU Medical recalls specific IV sets that may contain a metallic burr in stopcocks, which could cause injury during use. Affected products include various 15-drop admin sets with 3-way stopcocks.
ICU MedicalAug 31, 2017 - Lower riskMedical device
ICU Medical, Inc. recalls 140" (356 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, Remv 4-Way Stopcock, Clave¿, Rotating Luer, 2 Ext,
ICU Medical recalls 140" Y-Type Blood Sets with 170-micron filters due to potential DEHP contamination despite labeling as DEHP-free. Affected units may pose health risks during blood collection procedures.
ICU MedicalJul 31, 2017 - Stop using nowDrug
ICU Medical Inc recalls 0.9% Sodium Chloride Injection, USP in 1000 mL Single Dose Flexible Container, Hospira, Inc., Lake Forest, IL 60045 USA
ICU Medical recalls 1000mL 0.9% Sodium Chloride Injection due to possible stainless steel particles. Affected units have NDC# 0409-7983-09 and lot 61-841-FW expiring 01/01/2018.
ICU MedicalJul 26, 2017
ICU Medical, Inc. recall questions
How many recalls has ICU Medical, Inc. had?
376 recalls from ICU Medical, Inc. are on record with U.S. safety agencies, from 2017–2026 (359 medical device, 17 drug).
What is the most recent ICU Medical, Inc. recall?
ICU Medical, Inc. recalls CADD Yellow Medication Cassette Reservoir with NRFit connector US Product Codes: 21-7600-24, 21-7609-24 OUS Product, dated Aug 20, 2026. Every ICU Medical, Inc. recall is listed on this page, newest first.
Why are ICU Medical, Inc. products recalled?
The most common reasons on record: The infusion sets were manufactured with an incorrect spin collar. (6); Lack of assurance of sterility: Bags have potential to leak. (5); Due to the incorrect filter assembly. (4); Potential for leakage due to defect in the thermoset check valve component. (3).
What should I do if I have a recalled ICU Medical, Inc. product?
Match the model, catalog or lot number on your device to the recall. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals. Report problems to FDA MedWatch.
How do I get alerts for new ICU Medical, Inc. recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.