Manufacturer
657 recalls in our database name ICU Medical, Inc. as the manufacturing or recalling firm.
Of the 657 recalls from ICU Medical, Inc. we have scored against our rubric, 2 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 51 (8%) are Severe.
Which agencies issued them
The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.
Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.
ICU Medical is recalling 134,700 ChemosafeLock Bag Spikes because the port weld of the drug transfer device may separate or break during use and leak.
ICU Medical is recalling 400 ChemoLock connectors with Mini Bag Spike because the port weld of the drug transfer device may separate or break during use and leak.
ICU Medical is recalling 5,700 7.5-inch extension sets with a ChemoLock port and graduated adapter because the port weld may separate or break during use and leak.
ICU Medical is recalling 1,600 6-inch extension sets with MicroClave Clear and ChemoLock port because the port weld of the drug transfer device may separate or break during use and leak.
ICU Medical is recalling 23,203 IV administration sets because the burette component is missing an internal shutoff valve intended to stop fluid flow.
Smiths Medical NRFit CADD Yellow Medication Cassette Reservoirs, 100 mL, product code 21-7600-24, may have weakened medication bag welds that could allow leakage. 15,546 units are affected.
Smiths Medical CADD Medication Cassette Reservoirs may have weakened medication bag welds along the bag perimeter, which could result in medication leakage. 265,500 units are affected.
Smiths Medical CADD Medication Cassette Reservoirs with flow stop, 50 mL, product code 21-7301-24, may have weakened medication bag welds that could allow leakage. 211,750 units are affected.
Smiths Medical CADD Yellow Medication Cassette Reservoirs with flow stop, 100 mL, product code 21-7300-24, may have weakened medication bag welds that could allow leakage. 289,098 units are affected.
Smiths Medical CADD Medication Cassette Reservoirs, 50 mL, product code 21-7001-24, may have weakened medication bag welds that could allow leakage. 29,811 units are affected.
Smiths Medical CADD Medication Cassette Reservoirs with flow stop, 100 mL, product code 21-7302-24, may have weakened medication bag welds that could allow leakage. 987,911 units are affected.
The Plum Duo Infusion System is being recalled because two sequences of programming events and alarm interactions may cause the user interface to become unresponsive. 4,677 units are affected.
SwabCap Disinfecting Caps for needlefree connectors are being recalled because an incomplete seal may let isopropyl alcohol evaporate, which may result in inadequate disinfection. 1,445,600 units affected.
ICU Medical is recalling Plum Solos infusion pumps (Item 400011001) with software version 1.1.1 due to a workflow that may bypass the Maximum Dose Limit alert, which is designed to prevent overdose. The defect affects 214 units distributed across nine US states and the Philippines.
ICU Medical is recalling Plum Duo infusion pumps with software version 1.1.1 because a workflow may bypass the Maximum Dose Limit alert, potentially allowing unsafe medication doses to be programmed.
ICU Medical is recalling LifeShield Drug Library Management software v2.1 and v2.2 due to defects that could allow over-delivery of medication to patients or unauthorized modification of drug parameters.
ICU Medical recalls Potassium Chloride 20 mEq IV injection due to mislabeled overwrap showing 10 mEq instead of the correct strength. The correct dose is printed on the actual container.
ICU Medical recalls Potassium Chloride Injection (lot 1023172) whose overwrap labeled as 10 mEq may contain 20 mEq containers, creating overdose risk. Product distributed nationwide.
ICU Medical is recalling 6,000 units of ChemoLock Close Vial Spike (Model CL-80) due to incorrect packaging and labeling of finished goods. Units were distributed in Illinois and Canada.
Counterfeit CSB batteries are being used in Plum Infusion Systems. These unauthorized batteries fail to hold their charge and have not been tested for use with the pumps.
ICU Medical is recalling Plum A+ and Plum A+3 infusion pump batteries due to a manufacturing defect that may cause premature capacity loss and reduced runtime. Approximately 14,744 units were distributed worldwide.
ICU Medical is recalling 130,826 units of Plum 360/A+ spare batteries due to a manufacturing defect that causes earlier-than-expected battery capacity loss and reduced runtime.
ICU Medical is recalling Plum 360 Infusion System replacement batteries due to a manufacturing defect that may cause loss of capacity and decreased runtime earlier than expected. Approximately 11,961 units were distributed worldwide.
ICU Medical recalls approximately 93,135 Plum 360 infusion pumps due to a manufacturing defect that could prevent alarm signals from sounding. The devices were manufactured between July 2020 and December 2021.
ICU Medical Inc is recalling replacement batteries used in Plum A+ and A+3 infusion pump systems. A manufacturing defect may cause batteries to lose capacity earlier than expected.
Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.
ICU Medical
California-based company that develops, manufactures, and sells medical technologies used in vascular therapy, oncology, and critical care applications
Source: Wikidata (Q5969799), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.