Recall archive
54 recalls · page 1 of 3
Reported Sep 23, 2026
Plum administration sets
Moderate riskThis product could cause temporary or reversible health problems — stop using it.ICU Medical, Inc.
Matched: Brand — Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored…
7 more products in this recall
FDA (weekly enforcement report)
Reported Sep 2, 2026Updated Sep 16, 2026
IV Sets with drip chambers
Moderate riskThis product could cause temporary or reversible health problems — stop using it.ICU Medical, Inc.
Matched: Brand — Product may have black specks which could result in a delay in therapy.
FDA (weekly enforcement report)
Reported Jul 22, 2026
ICU Medical Plum Duo Infusion Pump, v1.2.3: 1) Item Number 400020401 and 2) Item Number 400020403; infusion pump
Moderate riskThis product could cause temporary or reversible health problems — stop using it.ICU Medical, Inc.
Matched: Brand · Product · Product details — 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…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jun 17, 2026
Plum Solo Precision IV Pump, 40001-0401
Moderate riskThis product could cause temporary or reversible health problems — stop using it.ICU Medical, Inc.
Matched: Brand — 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…
2 more products in this recall
FDA (openFDA device enforcement)
Reported May 27, 2026
Oncology Kit w/60" (152 cm) Appx 2.2 ml, Smallbore Ext Set w/ChemoLock Port, Clamp, Anti-Siphon Valve, Spiros;…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.ICU Medical, Inc.
Matched: Brand — Oncology sets/closed system transfer devices with extension sets may leak resulting in therapy delayed if noticed and corrected during setup, but if…
FDA (openFDA device enforcement)
Reported Jan 28, 2026
Tego Connector: REF: 011-D1000, 01C-D1000, 055-D1000, D1000; Conector Tego: REF: LAT-D1000
Moderate riskThis product could cause temporary or reversible health problems — stop using it.ICU Medical, Inc.
Matched: Brand — Needle free access device intended as accessory to vascular access used in hemodialysis or accessory to intravascular administration sets has a…
3 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 21, 2026
Plum Duo Infusion System, List Number 40002-04-01
Moderate riskThis product could cause temporary or reversible health problems — stop using it.ICU Medical, Inc.
Matched: Brand · Reason for recall — 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…
FDA (openFDA device enforcement)
Reported Dec 31, 2025
LifeShield Drug Library Management (DLM); LifeShield Infusion Safety Software Suite v2.2 List Number 17003-02
Moderate riskThis product could cause temporary or reversible health problems — stop using it.ICU Medical, Inc.
Matched: Brand — For certain customers, the Change Summary review option ceases to operate as expected for any migrated library after the migration has been…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Nov 26, 2025
POTASSIUM CHLORIDE Inj., 20 mEq total in 50 mL Flexible Container, Highly concentrated 400 mEq/L, Rx Only, ICU Medical,…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Otsuka ICU Medical LLC
Matched: Brand · Product · Product details — Labeling: Label Error on Declared Strength-The overwrap label may incorrectly identify the product as POTASSIUM CHLORIDE Inj. 10 mEq instead of…
1 more product in this recall
FDA (openFDA drug enforcement)
Reported Nov 5, 2025
ChemoLock Bag Spike, 01 units REF: CL-10-10
Moderate riskThis product could cause temporary or reversible health problems — stop using it.ICU Medical, Inc.
Matched: Brand — Port weld of drug transfer device may separate or break during use and potentially result in a leak.
37 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 5, 2025
0.9% SODIUM CHLORIDE Injection, USP, 100 mL, Rx only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Otsuka ICU Medical LLC
Matched: Brand · Product · Product details — Lack of Assurance of Sterility: Potential for flexible container leaks.
FDA (openFDA drug enforcement)
Reported Oct 29, 2025
IV Administration sets. 23" (58 cm) 150 mL Burette Set (Clave, Shut Off) w/Clave, Luer Lock, REF: B33359; 23" (58 cm)…
High riskUsing this product could cause serious injury, illness or death — stop using it now.ICU Medical, Inc.
Matched: Brand — IV Gravity burette administration set burette component is missing an internal shutoff valve intended to stop fluid flow, which if used may result in…
FDA (openFDA device enforcement)
Reported Aug 13, 2025
Plum Duo Infusion System, List Number: 400020401
High riskUsing this product could cause serious injury, illness or death — stop using it now.ICU Medical, Inc.
Matched: Brand · Reason for recall — ICU Medical identified two sequences of programming events and alarm interactions that may cause the user interface to become unresponsive.
FDA (openFDA device enforcement)
Reported Jul 23, 2025
SwabCap Disinfecting Cap for Needlefree Connectors: SwabSleeve, REF: SCXT3-5-2000; SwabCap, 200-ct. Box, REF: SCXT3-2000
Moderate riskThis product could cause temporary or reversible health problems — stop using it.ICU Medical, Inc.
Matched: Brand — Due to a manufacturing issue, disinfecting cap for needle-free connectors may have an incomplete seal between the foil lid and plastic container,…
FDA (openFDA device enforcement)
Reported Jun 25, 2025
ICU Medical Plum Duo, Item numbers: 1) 400020401, 2) 400021001 , and 3) 400021003; infusion pump
Moderate riskThis product could cause temporary or reversible health problems — stop using it.ICU Medical, Inc.
Matched: Brand · Product · Product details — 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…
1 more product in this recall
FDA (openFDA device enforcement)
Reported May 21, 2025
LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software SUite v2.1 and v2.2
Moderate riskThis product could cause temporary or reversible health problems — stop using it.ICU Medical, Inc.
Matched: Brand — Firm has identified Drug Library Management defects in the software: 1) DLM software does not allow user to create percentage dose rate or rate…
FDA (openFDA device enforcement)
Reported Mar 19, 2025
POTASSIUM CHLORIDE Inj., 20 mEq total in 100 mL flexible container 24 x case, 200 mEq/L, Rx Only, ICU Medical, Inc.,…
High riskUsing this product could cause serious injury, illness or death — stop using it now.ICU Medical, Inc.
Matched: Brand · Product · Product details — Labeling: Label Error on Declared Strength. Cases labeled POTASSIUM CHLORIDE 20 mEq, may contain flexible containers with overwrap mislabeled as 10…
1 more product in this recall
FDA (openFDA drug enforcement)
Reported Dec 18, 2024
ChemoLock Close Vial Spike REF CL-80 The Chemolock Closed System Transfer Device prevents the transfer of environmental…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.ICU Medical, Inc.
Matched: Brand — Due to finished goods incorrectly packaged and labeled.
FDA (openFDA device enforcement)
Reported Nov 27, 2024
Allegedly counterfeit batteries manufactured by CSB batteries being used with Plum Infusion Systems: Plum 360" Infusion…
High riskUsing this product could cause serious injury, illness or death — stop using it now.ICU Medical, Inc.
Matched: Brand · Reason for recall — ICU Medical has received reports of allegedly counterfeit CSB batteries being used with Plum Infusion Systems. While these non-OEM batteries are…
FDA (openFDA device enforcement)
Reported Nov 23, 2022
0.9% Sodium Chloride Injection, USP, 100 mL flexible container bag, Rx Only, ICU Medical, Inc., Lake Forest, Illinois,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.ICU Medical Inc.
Matched: Brand · Product · Product details — Lack of assurance of sterility: Bags have the potential to leak in the flexible containers which may compromise sterility.
FDA (openFDA drug enforcement)
Reported Sep 21, 2022
MicroClave Clear Neutral Connector. A bidirectional connector used as an accessory to an intravascular catheter placed…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.ICU Medical, Inc.
Matched: Brand — Due to a manufacturing defect which results in a visible gap between the connector's top and bottom housing.
5 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 14, 2022
Product Description/Item: ChemoLock Bag Spike, 10 units/CL-10-10; ChemoLock BAG SPIKE w/ ADDITIVE PORT, DRY…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.ICU Medical, Inc.
Matched: Brand — Ports have a potential for unintended disconnection, inability to connect to or fully engage with injectors, due to a variation in the spring inside…
1 more product in this recall
FDA (openFDA device enforcement)
Reported May 19, 2021
REF CH3397 Oncology Kit w/Spiros¿, Red Cap, Bag Spike w/Clave Additive Port LOT 5118610 - Product Usage: for use in the…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.ICU Medical, Inc.
Matched: Brand — 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…
25 more products in this recall
FDA (openFDA device enforcement)
Reported Mar 31, 2021
0.9% SODIUM CHLORIDE Irrigation, USP 1000 mL Semi-Rigid Bottle, Rx only, Manufactured for ICU Medical, Inc., Lake…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.ICU Medical Inc.
Matched: Brand · Product · Product details — Presence of particulate matter.one confirmed customer report of particulate matter within two semi-rigid bottles identified prior to use
FDA (openFDA drug enforcement)
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