--- title: "ICU Medical, Inc. Recalls: Agency-Reported Status and History (Oct 1, 2026) | Is It on Recall" description: "Search ICU Medical, Inc. recall records, lots, firms and dates. Reported status can be incomplete; use the linked agency notice for current instructions." url: https://isitonrecall.com/brand/icu-medical-inc/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Home](https://isitonrecall.com/) / Brand archive # ICU Medical, Inc. recall records **96** reported ongoing 96 records in this archive. Latest source date Aug 20, 2026. FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## Records and reported status Aug 20, 2026 FDA device enforcement ### [CADD Yellow Medication Cassette Reservoir with NRFit connector US Product Codes: 21-7600-24, 21-7609-24 OUS Product Codes: 21-7609-24 21-7600-24 21-7600-24 21-7600-24 21-7609-24...](https://isitonrecall.com/recall/fda-device-z-3212-2026-cadd-yellow-medication-cassette-reservoir-with-nrfit-connector-us-product-codes-21-7600-24-21-7609-2/) 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 medication, exposure to infectious or toxic agents, or air embolus. Class II Reported ongoing Distribution: Worldwide - US Nationwide distribution in the states of AR, CA, FL, IL, IN, LA, MI, MO, MS, TN, TX, VA, WI and the countries of Austria, Australia, Belgium, Costa Rica, Germany,... [Official source for CADD Yellow Medication Cassette Reservoir with NRFit connector US Product Codes: 21-7600-24, 21-7...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-3212-2026%22) Jun 24, 2026 FDA device enforcement ### [Hotline Fluid Warming Set, single use device, is designed to warm blood and intravenous fluids and deliver them to the patient's intravenous access site at normothermic temperat...](https://isitonrecall.com/recall/fda-device-z-2759-2026-hotline-fluid-warming-set-single-use-device-is-designed-to-warm-blood-and-intravenous-fluids-and-del/) 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 the tubing to return connector bond. Class II Reported ongoing Distribution: Worldwide - US Nationwide distribution. [Official source for Hotline Fluid Warming Set, single use device, is designed to warm blood and intravenous fluids an...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2759-2026%22) Jun 10, 2026 FDA device enforcement ### [ICU Medical Plum Duo Infusion Pump, v1.2.3: 1) Item Number 400020401 and 2) Item Number 400020403; infusion pump](https://isitonrecall.com/recall/fda-device-z-2723-2026-icu-medical-plum-duo-infusion-pump-v1-2-3-1-item-number-400020401-and-2-item-number-400020403-infusi/) 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 programmed rate. Class II Reported ongoing Distribution: Worldwide distribution - US Nationwide and the country of Canada. [Official source for ICU Medical Plum Duo Infusion Pump, v1.2.3: 1) Item Number 400020401 and 2) Item Number 400020403...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2723-2026%22) Jun 10, 2026 FDA device enforcement ### [ICU Medical Plum Solo Precision IV Pump, v1.0.3, Item Number 400010401; infusion pump](https://isitonrecall.com/recall/fda-device-z-2724-2026-icu-medical-plum-solo-precision-iv-pump-v1-0-3-item-number-400010401-infusion-pump/) 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 programmed rate. Class II Reported ongoing Distribution: Worldwide distribution - US Nationwide and the country of Canada. [Official source for ICU Medical Plum Solo Precision IV Pump, v1.0.3, Item Number 400010401; infusion pump](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2724-2026%22) May 12, 2026 FDA device enforcement ### [Plum administration sets](https://isitonrecall.com/recall/fda-device-z-3156-2026-plum-administration-sets/) Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride (PVC) material within the drip chamber wall. The presence of discoloration and particulate matte... Class II Reported ongoing Distribution: Worldwide - US Nationwide distribution including in the states and territories of ND, TX, CT, KY, CO, AR, NC, NJ, VA, MD, OK, AK, IA, IN, KS, OR, CA, OH, WA, GA, AL, SC, MA, HI,... [Official source for Plum administration sets](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-3156-2026%22) May 12, 2026 FDA device enforcement ### [IV Non-Dedicated Gravity Administration Sets with drip chambers](https://isitonrecall.com/recall/fda-device-z-3157-2026-iv-non-dedicated-gravity-administration-sets-with-drip-chambers/) Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride (PVC) material within the drip chamber wall that does not enter the fluid path, which if seen by... Class II Reported ongoing Distribution: Worldwide - US Nationwide distribution including in the states and territories of ND, TX, CT, KY, CO, AR, NC, NJ, VA, MD, OK, AK, IA, IN, KS, OR, CA, OH, WA, GA, AL, SC, MA, HI,... [Official source for IV Non-Dedicated Gravity Administration Sets with drip chambers](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-3157-2026%22) May 12, 2026 FDA device enforcement ### [Oncology sets with drip chambers](https://isitonrecall.com/recall/fda-device-z-3158-2026-oncology-sets-with-drip-chambers/) Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride (PVC) material within the drip chamber wall that does not enter the fluid path, which if seen by... Class II Reported ongoing Distribution: Worldwide - US Nationwide distribution including in the states and territories of ND, TX, CT, KY, CO, AR, NC, NJ, VA, MD, OK, AK, IA, IN, KS, OR, CA, OH, WA, GA, AL, SC, MA, HI,... [Official source for Oncology sets with drip chambers](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-3158-2026%22) May 12, 2026 FDA device enforcement ### [Oncology sets with drip chambers](https://isitonrecall.com/recall/fda-device-z-3159-2026-oncology-sets-with-drip-chambers/) Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride (PVC) material within the drip chamber wall that does not enter the fluid path, which if seen by... Class II Reported ongoing Distribution: Worldwide - US Nationwide distribution including in the states and territories of ND, TX, CT, KY, CO, AR, NC, NJ, VA, MD, OK, AK, IA, IN, KS, OR, CA, OH, WA, GA, AL, SC, MA, HI,... [Official source for Oncology sets with drip chambers](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-3159-2026%22) May 12, 2026 FDA device enforcement ### [IV Sets with drip chambers](https://isitonrecall.com/recall/fda-device-z-3160-2026-iv-sets-with-drip-chambers/) Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride (PVC) material within the drip chamber wall. The presence of discoloration and particulate matte... Class II Reported ongoing Distribution: Worldwide - US Nationwide distribution including in the states and territories of ND, TX, CT, KY, CO, AR, NC, NJ, VA, MD, OK, AK, IA, IN, KS, OR, CA, OH, WA, GA, AL, SC, MA, HI,... [Official source for IV Sets with drip chambers](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-3160-2026%22) May 12, 2026 FDA device enforcement ### [IV Sets with drip chambers](https://isitonrecall.com/recall/fda-device-z-3161-2026-iv-sets-with-drip-chambers/) Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride (PVC) material within the drip chamber wall. The presence of discoloration and particulate matte... Class II Reported ongoing Distribution: Worldwide - US Nationwide distribution including in the states and territories of ND, TX, CT, KY, CO, AR, NC, NJ, VA, MD, OK, AK, IA, IN, KS, OR, CA, OH, WA, GA, AL, SC, MA, HI,... [Official source for IV Sets with drip chambers](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-3161-2026%22) May 12, 2026 FDA device enforcement ### [IV Sets with drip chambers](https://isitonrecall.com/recall/fda-device-z-3162-2026-iv-sets-with-drip-chambers/) Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride (PVC) material within the drip chamber wall. The presence of discoloration and particulate matte... Class II Reported ongoing Distribution: Worldwide - US Nationwide distribution including in the states and territories of ND, TX, CT, KY, CO, AR, NC, NJ, VA, MD, OK, AK, IA, IN, KS, OR, CA, OH, WA, GA, AL, SC, MA, HI,... [Official source for IV Sets with drip chambers](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-3162-2026%22) May 12, 2026 FDA device enforcement ### [IV Sets with drip chambers](https://isitonrecall.com/recall/fda-device-z-3163-2026-iv-sets-with-drip-chambers/) Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride (PVC) material within the drip chamber wall. The presence of discoloration and particulate matte... Class II Reported ongoing Distribution: Worldwide - US Nationwide distribution including in the states and territories of ND, TX, CT, KY, CO, AR, NC, NJ, VA, MD, OK, AK, IA, IN, KS, OR, CA, OH, WA, GA, AL, SC, MA, HI,... [Official source for IV Sets with drip chambers](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-3163-2026%22) Apr 29, 2026 FDA device enforcement ### [Plum Solo Precision IV Pump, 40001-0401](https://isitonrecall.com/recall/fda-device-z-2311-2026-plum-solo-precision-iv-pump-40001-0401/) 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 delivery. This may potentially lead to under- or over-delivery. Class II Reported ongoing Distribution: Worldwide - US Nationwide distribution in the states of ID, IL, IN, KS, MA, MD, NM, NY, PA, TN, TX and the country of Canada. [Official source for Plum Solo Precision IV Pump, 40001-0401](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2311-2026%22) Apr 29, 2026 FDA device enforcement ### [Plum Duo Infusion Pump, 40002-0401](https://isitonrecall.com/recall/fda-device-z-2312-2026-plum-duo-infusion-pump-40002-0401/) 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 delivery. This may potentially lead to under- or over-delivery. Class II Reported ongoing Distribution: Worldwide - US Nationwide distribution in the states of ID, IL, IN, KS, MA, MD, NM, NY, PA, TN, TX and the country of Canada. [Official source for Plum Duo Infusion Pump, 40002-0401](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2312-2026%22) Apr 29, 2026 FDA device enforcement ### [Plum Duo Precision IV Pump, 40002-0403](https://isitonrecall.com/recall/fda-device-z-2313-2026-plum-duo-precision-iv-pump-40002-0403/) 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 delivery. This may potentially lead to under- or over-delivery. Class II Reported ongoing Distribution: Worldwide - US Nationwide distribution in the states of ID, IL, IN, KS, MA, MD, NM, NY, PA, TN, TX and the country of Canada. [Official source for Plum Duo Precision IV Pump, 40002-0403](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2313-2026%22) Mar 24, 2026 FDA device enforcement ### [Oncology Kit w/60" (152 cm) Appx 2.2 ml, Smallbore Ext Set w/ChemoLock Port, Clamp, Anti-Siphon Valve, Spiros; ChemoLock; Syringe Transfer Set w/MicroClave, ChemoLock Port, REF:...](https://isitonrecall.com/recall/fda-device-z-2210-2026-oncology-kit-w-60-152-cm-appx-2-2-ml-smallbore-ext-set-w-chemolock-port-clamp-anti-siphon-valve-spir/) 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 during therapy this may result in therapy interruption with the potential for the patient to... Class II Reported ongoing Distribution: US Nationwide distribution in the states of GA, MA, OH, NC, CA, ND, MI, TX, FL, AR, CT, PA, WA, WI, CO, VT, NY, NH, KY, IA, KS, AL, NM, IL, MO, NJ. [Official source for Oncology Kit w/60" (152 cm) Appx 2.2 ml, Smallbore Ext Set w/ChemoLock Port, Clamp, Anti-Siphon V...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2210-2026%22) Dec 19, 2025 FDA device enforcement ### [Pulsator Arterial Blood Sampling Kit, Item Numbers 4044EG-1 4080P-2 4084P-1 4080PE 4080PG](https://isitonrecall.com/recall/fda-device-z-1100-2026-pulsator-arterial-blood-sampling-kit-item-numbers-4044eg-1-4080p-2-4084p-1-4080pe-4080pg/) 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 leakage during sampling of arterial blood or leakage during fluid delivery. Class II Reported ongoing Distribution: US Nationwide distribution in the states of CA, FL, IL, IN, MA, MI, MN, MO, NE, NJ, NY, OH, OK, TX, WA. [Official source for Pulsator Arterial Blood Sampling Kit, Item Numbers 4044EG-1 4080P-2 4084P-1 4080PE 4080PG](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1100-2026%22) Dec 19, 2025 FDA device enforcement ### [Portex Spinal Tray, Item No. A3729-24 A3595](https://isitonrecall.com/recall/fda-device-z-1101-2026-portex-spinal-tray-item-no-a3729-24-a3595/) 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 leakage during sampling of arterial blood or leakage during fluid delivery. Class II Reported ongoing Distribution: US Nationwide distribution in the states of CA, FL, IL, IN, MA, MI, MN, MO, NE, NJ, NY, OH, OK, TX, WA. [Official source for Portex Spinal Tray, Item No. A3729-24 A3595](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1101-2026%22) Dec 19, 2025 FDA device enforcement ### [Tego Connector: REF: 011-D1000, 01C-D1000, 055-D1000, D1000; Conector Tego: REF: LAT-D1000](https://isitonrecall.com/recall/fda-device-z-1111-2026-tego-connector-ref-011-d1000-01c-d1000-055-d1000-d1000-conector-tego-ref-lat-d1000/) 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 bulge at the top, separate from the body, tear; may result in fluid leaks, occluded fluid... Class II Reported ongoing Distribution: Worldwide - US Nationwide distribution including in the states of FL, AZ, RI, TN, KS, NJ, NY, VA, SC, GA, CA, MS, TX, OH, NC, MA, WA, IL, PA, NV, NH, LA, MI, NE, ME, MN, NM, OK,... [Official source for Tego Connector: REF: 011-D1000, 01C-D1000, 055-D1000, D1000; Conector Tego: REF: LAT-D1000](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1111-2026%22) Dec 15, 2025 FDA device enforcement ### [Plum Duo Infusion System, List Number 40002-04-01](https://isitonrecall.com/recall/fda-device-z-1094-2026-plum-duo-infusion-system-list-number-40002-04-01/) 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 Pump fails, the pump may not produce audible alarms, alerts, or provide audible feedback... Class II Reported ongoing Distribution: Worldwide - US Nationwide distribution. [Official source for Plum Duo Infusion System, List Number 40002-04-01](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1094-2026%22) ## Reasons in these listed records - 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 medication, exposure to infectious or toxic agents, or air embolus. - 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 the tubing to return connector bond. - 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 programmed rate. - Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride (PVC) material within the drip chamber wall. The presence of discoloration and particulate matter in the fluid path ... These examples come from this result page and are not a ranking of every recall reason. ## Checking ICU Medical, Inc. ### Is there a recall on icu medical, inc. right now? This archive contains 96 records, including 96 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product. ### How do I check my package or product? Compare the product, firm and lot, date, model or serial identifiers with the notice. [Use the label-check guide](https://isitonrecall.com/guides/read-lot-codes/) if you need help locating an identifier. ### Does a matching name mean every item is included? A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall. ### What if the search finds no matching record? This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. [Check source coverage](https://isitonrecall.com/sources/) and the agency's current notices. ### Where can I find older records? Use [monthly archives](https://isitonrecall.com/archives/) or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page. ## Keep checking [Search ICU Medical, Inc.](https://isitonrecall.com/check/?q=ICU%20Medical%2C%20Inc.) [Browse related products](https://isitonrecall.com/products/) [Review source dates](https://isitonrecall.com/sources/)