ICU Medical, Inc. recalls
75 recalls in our records from 2012 to 2026: 65 FDA medical devices, 10 FDA drugs.
Recalls with full detail pages
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ICU Medical, Inc. medical device recall: IV Administration sets. 23
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…
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ICU Medical, Inc. medical device recall: Plum Duo Infusion System
ICU Medical identified two sequences of programming events and alarm interactions that may cause the user interface to become unresponsive.
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ICU Medical, Inc. drug recall: POTASSIUM CHLORIDE Inj
Labeling: Label Error on Declared Strength. Cases labeled POTASSIUM CHLORIDE 20 mEq, may contain flexible containers with overwrap mislabeled as 10 mEq. The correct…
Earlier and other recalls
These link to the official agency notice.
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ICU Medical, Inc. medical device recall: CADD Yellow Medication Cassette Reservoir with NRFit connector US… Official notice ↗
Reservoirs may exhibit medication leakage at the joint between luer connector and tubing. Issue could result in delay or interruption of therapy, under delivery of…
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ICU Medical, Inc. medical device recall: Plum administration sets Official notice ↗
Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride (PVC)…
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ICU Medical Inc. medical device recall: Hotline Fluid Warming Set Official notice ↗
ICU Medical became aware of an increased likelihood of leakage in specific Lots of L-70 HOTLINE Fluid Warming Sets due to potentially inadequate solvent application at…
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ICU Medical, Inc. medical device recall: ICU Medical Plum Duo Infusion Pump Official notice ↗
In a specific scenario, the pump will not decrement the Volume to be Infused (VTBI) displayed on the Delivery screen and may deliver up to twice the VTBI at the…
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ICU Medical, Inc. medical device recall: Plum Solo Precision IV Pump Official notice ↗
Under certain conditions, the pump may not display a soft limit alert, and will not notify the clinician of a soft limit violation before confirming and starting…
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ICU Medical, Inc. medical device recall: Oncology Kit w/60 Official notice ↗
Oncology sets/closed system transfer devices with extension sets may leak resulting in therapy delayed if noticed and corrected during setup, but if the leak occurs…
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ICU Medical, Inc. medical device recall: Tego Connector: REF: 011-D1000 Official notice ↗
Needle free access device intended as accessory to vascular access used in hemodialysis or accessory to intravascular administration sets has a silicone seal which may…
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ICU Medical, Inc. medical device recall: ICU Medical Plum Duo Infusion Pump Official notice ↗
Plum Solo and Duo Infusion pumps include a feature, that when selected, automatically flushes the downstream line after a piggyback therapy. The programmed flush volume…
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ICU Medical Inc. medical device recall: Pulsator Arterial Blood Sampling Kit Official notice ↗
Affected lots of syringes may have a crack on the syringe collar, which may lead to delayed or repeated blood draw/fluid delivery. This issue may also lead to blood…
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ICU Medical, Inc. medical device recall: Plum Duo Infusion System Official notice ↗
ICU Medical received one lot of defective primary speakers from our supplier that may fail to produce an audible sound. If the primary speaker in your Plum Duo Infusion…
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ICU Medical, Inc. medical device recall: LifeShield Drug Library Management Official notice ↗
Software issue only allows Concentration Limits to be defined to one digit of precision past the decimal point (0.1) instead of three digits (0.001). If the user is…
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ICU Medical, Inc. medical device recall: LifeShield Drug Library Management Official notice ↗
For certain customers, the Change Summary review option ceases to operate as expected for any migrated library after the migration has been completed. Users must use…
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ICU Medical, Inc. medical device recall: ChemoLock Bag Spike Official notice ↗
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
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ICU Medical Inc. medical device recall: Smiths Medical CADD Medication Cassette Reservoir with clamp and… Official notice ↗
Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag welds along the bag perimeter inside the plastic housing. This could…
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ICU Medical, Inc. medical device recall: SwabCap Disinfecting Cap for Needlefree Connectors: SwabSleeve Official notice ↗
Due to a manufacturing issue, disinfecting cap for needle-free connectors may have an incomplete seal between the foil lid and plastic container, which may result in…
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ICU Medical, Inc. medical device recall: ICU Medical Plum Duo Official notice ↗
Internal testing found that Plum Duo pumps with software version 1.1.1 have a workflow that may result in bypassing the Maximum Dose Limit alert. The Maximum Dose Limit…
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ICU Medical, Inc. medical device recall: LifeShield Drug Library Management Official notice ↗
Firm has identified Drug Library Management defects in the software: 1) DLM software does not allow user to create percentage dose rate or rate change values with…
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ICU Medical, Inc. medical device recall: ChemoLock Close Vial Spike REF CL-80 The Chemolock Closed System… Official notice ↗
Due to finished goods incorrectly packaged and labeled.
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ICU Medical, Inc. medical device recall: Allegedly counterfeit batteries manufactured by CSB batteries being… Official notice ↗
ICU Medical has received reports of allegedly counterfeit CSB batteries being used with Plum Infusion Systems. While these non-OEM batteries are visually similar to the…
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ICU Medical Inc medical device recall: Replacement Battery List Number SUB0000864 Official notice ↗
Due to a manufacturing defect from the battery supplier, affected batteries may experience a loss of capacity earlier in the battery lifecycle than expected and overall…
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ICU Medical Inc medical device recall: Plum 360 Infusion System Official notice ↗
Due to a manufacturing defect of a supplier provided component, there is a potential that the audible signal for an alarm may not sound under certain conditions.
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ICU Medical Inc medical device recall: Replacement Battery List Number SUB0000864 Official notice ↗
Due to a manufacturing defect from the battery supplier, affected batteries may experience a loss of capacity earlier in the battery lifecycle than expected and overall…
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ICU Medical Inc drug recall: 0.9% Sodium Chloride Injection Official notice ↗
Lack of assurance of sterility: Bags have the potential to leak in the flexible containers which may compromise sterility.
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ICU Medical, Inc. medical device recall: MicroClave Clear Neutral Connector. A bidirectional connector used as… Official notice ↗
Due to a manufacturing defect which results in a visible gap between the connector's top and bottom housing.
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ICU Medical, Inc. medical device recall: Product Description/Item: ChemoLock Bag Spike Official notice ↗
Ports have a potential for unintended disconnection, inability to connect to or fully engage with injectors, due to a variation in the spring inside the Port, which may…
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ICU Medical Inc drug recall: AMINOSYN II 15% An Amino Acid Injection Official notice ↗
Presence of Particulate Matter: Particulate matter identified as fibers, hair, and proteinaceous material along with other particles, found in retain smples.
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ICU Medical, Inc. medical device recall: REF CH3397 Oncology Kit w/Spiros¿ Official notice ↗
Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated…
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ICU Medical Inc drug recall: 0.9% SODIUM CHLORIDE Irrigation Official notice ↗
Presence of particulate matter.one confirmed customer report of particulate matter within two semi-rigid bottles identified prior to use
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ICU Medical, Inc. medical device recall: 60 In Official notice ↗
Due to the incorrect filter assembly.
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ICU Medical, Inc. medical device recall: icumedical Cogent" Hemodynamic Monitoring System - Product Usage:… Official notice ↗
Due to a potential software issue, the display may show the incorrect continuous cardiac output (CCO) values after PulseCO calibration.
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ICU Medical, Inc. medical device recall: 42 In Official notice ↗
Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid leakage may potentially cause delay of infusion, contamination of the fluid…
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ICU Medical, Inc. medical device recall: Ref Mc330209 6 Official notice ↗
Incorrect filter assemblies in IV administration set.
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ICU Medical, Inc. medical device recall: NanoClave Connector Official notice ↗
Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with…
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ICU Medical Inc drug recall: LACTATED RINGER'S Injection Official notice ↗
Presence of Particulate Matter: confirmed customer complaint for the presence of particulate matter identified as iron oxide.
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ICU Medical, Inc. medical device recall: Central Venous Catheters are indicated for the assessment of… Official notice ↗
Inability for the guidewire to pass through the needles included with the catheter kits.
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ICU Medical, Inc. medical device recall: The Cogent Hemodynamic Monitoring System. REF58400-000 Official notice ↗
Firm identified software issues which leads to the patient ID and patient information not being stored in the system.
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ICU Medical, Inc. medical device recall: REF: AH7117 111" 10 Drop Admin Set w/2 Inj Sites Official notice ↗
There is a potential that IV administration sets contain a 15 drops/mL drop cannula instead of a 10 drops/mL drop cannula within the drip chamber. An infusion set with…
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ICU Medical, Inc. medical device recall: ICU Medical Cogent Hemodynamic Monitoring System Official notice ↗
Firm identified several software issues through internal testing of its Cogent Hemodynamic Monitoring System. These issues may result in inaccurate monitoring data, unit…
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ICU Medical Inc drug recall: LACTATED RINGER'S Injection Official notice ↗
Presence of Particulate Matter.
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ICU Medical Inc medical device recall: Plum 360 Infusion System With MedNet/ Smart Card Plug And Play Module Official notice ↗
A software malfunction of the infuser when used with a MedNet Custom Drug Library (CDL). When a new CDL is downloaded and installed on the infuser the infuser can become…
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ICU Medical Inc medical device recall: Infusion Pump I.V. Administration Official notice ↗
Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
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ICU Medical, Inc. medical device recall: icumedical ChemoClave Vented Vial Spike Official notice ↗
There is a potential for certain lots of ChemoLock and ChemoClave Vial Spikes to have plastic burr particulate originating from the protective cap used in the assembly…
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ICU Medical, Inc. medical device recall: ICU Medical Official notice ↗
Reports of pressure tubing separation between the sampling port and the high pressure tubing on certain lots of extravascular blood pressure transducers, which could…
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ICU Medical, Inc. medical device recall: icumedical ChemoLock Vial Spike Official notice ↗
There is a potential for one lot of ChemoLock Vial Spike to contain burr particulate
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ICU Medical Inc drug recall: 0.9% Sodium Chloride Injection Official notice ↗
CGMP Deviations
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ICU Medical, Inc. medical device recall: Thermoset Room Temperature Closed Loop Injectate Delivery System. 1… Official notice ↗
Potential for leakage due to defect in the thermoset check valve component.
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ICU Medical Inc medical device recall: SAPPHIRE Epidural Set Yellow-Striped Microbore Official notice ↗
There have been reports of distal occlusion alarms during the use of SAPPHIRE Epidural Set Yellow-Striped administration sets.
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ICU Medical Inc drug recall: 5% Dextrose Injection Official notice ↗
Lack of Assurance of Sterility; bags have the potential to leak
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ICU Medical, Inc. medical device recall: ICU Medical 14 Official notice ↗
Design change implemented changing the device from a blood set with a filter to a transfer set without a filter. Both devices had the same listing number. Customers may…
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ICU Medical, Inc. medical device recall: 119" Blood Set w/200 Micron Filter Official notice ↗
Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.
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ICU Medical Inc drug recall: 0.45% Sodium Chloride Injection Official notice ↗
Lack of assurance of sterility: Bags have potential to leak.
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ICU Medical, Inc. medical device recall: Hemodynamic monitoring system Official notice ↗
When continuous cardiac output monitoring with a pulmonary artery catheter is placed in the Pause mode, the catheter thermal coil may continue while in pause mode.
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ICU Medical, Inc. medical device recall: 6.5 Official notice ↗
The infusion sets were manufactured with an incorrect spin collar.
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ICU Medical Inc medical device recall: ICU Mednet(TM) Medication Management Suite 6.1 and 6.21 Official notice ↗
Issue 1: The MedNet Meds 6.1 and 6.21 programs, under certain conditions, can change the piggyback medication entry set settings for existing defined medication entries.…
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ICU Medical, Inc. medical device recall: SURPLUG MICRO CONNECTOR Item No. 066-C3352 Official notice ↗
ICU Medical has identified certain stopcocks that are incorporated in IV sets may contain a metallic burr.
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ICU Medical Inc medical device recall: Plum 360 Infusion System Official notice ↗
(1) Under certain conditions, if a malfunction alarm occurs while the pump is in the "Paused" state waiting for the distal pressure to decrease, the pump cannot be…
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ICU Medical Inc drug recall: 0.9% Sodium Chloride Injection Official notice ↗
Presence of Particulate Matter; stainless steel
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ICU Medical Inc medical device recall: Plum 360 Infusion System Official notice ↗
Potential for the Connectivity Engine Module of the affected unit to disengage from the main chassis, causing the unit to shut down without an alarm notification. This…
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ICU Medical, Inc. medical device recall: 18 cm Official notice ↗
The connection between the Female Luer and the NanoClave¿ manifold has the potential for developing a leak.
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ICU Medical, Inc. medical device recall: 133" 60 Drop 24 Hour Primary Set w/2 Bravo24¿ Official notice ↗
ICU Medical Inc. has identified an isolated event involving a 15 drop drip chamber assembled on a device which should contain a 60 drop drip chamber.
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ICU Medical, Inc. medical device recall: Tego Connector Official notice ↗
ICU Medical Inc. has identified a potential risk of leaking with certain Tego Connector devices.
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ICU Medical, Inc. medical device recall: 4 Port "ON" Manifold Official notice ↗
ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
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ICU Medical, Inc. medical device recall: Transpac IV Monitoring Kit with SafeSet 84inch Arterial Pressure… Official notice ↗
ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
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ICU Medical, Inc. medical device recall: Diana Automated Compounding System Official notice ↗
ICU Medical Inc. has received a report of compounded volumes not meeting the accuracy specification by the Diana Compounding System when mixing volumes under 5ml.
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ICU Medical, Inc. medical device recall: 74 Official notice ↗
ICU Medical has identified an issue with a connection in an isolated number of I.V. infusion administration sets that incorporate the ChemLock additive port. In these…
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ICU Medical, Inc. medical device recall: 119 Official notice ↗
ICU Medical is recalling MicroClave T-Connectors because they have potential connection separation issues that could lead to leakage.
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ICU Medical, Inc. medical device recall: STAT 2 Flow Controller Official notice ↗
ICU is recalling the ConMed Stat 2 flow controller because it may deliver a significantly higher flow rate than was intended.
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ICU Medical, Inc. medical device recall: CAP Change Kit w/MicroClave Clear Official notice ↗
ICU Medical is recalling the BD PosiFlush Sterile Field Saline Flush Syringe because some unit packages may exhibit open seals which impacts package sterility and…
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ICU Medical, Inc. medical device recall: Transpac IV Trifurcated Monitoring Kit w/84" Safeset Reservoir Official notice ↗
ICU has become aware of an issue with a component where the connection on an arterial monitoring kit may crack and cause a fluid leak.
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ICU Medical, Inc. medical device recall: NanoClave Connector Official notice ↗
ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak.
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ICU Medical, Inc. medical device recall: 3 PORT "OFF" MANIFOLD w/WASTE BAG Official notice ↗
ICU Medical, Inc. has identified a potential comingling of components where a 60 drop micro drip chamber may have been included on a 20 drop macro drip set.
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ICU Medical, Inc. medical device recall: High Pressure Stopcock Official notice ↗
The firm initiated the recall due to a molding defect in a high pressure stopcock where a small percentage of the side ports could become totally occluded.
Firm names are matched across agencies by name only. Different companies with similar names may be grouped together; check each official notice.