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 Inc. is recalling 88,960 bags of 0.45% Sodium Chloride Injection due to a lack of assurance of sterility and potential for leaking.
ICU Medical is recalling 941,496 bags of 0.9% Sodium Chloride Injection due to a lack of assurance of sterility and potential for leaking.
ICU Medical is recalling 525,984 bags of 0.9% Sodium Chloride Injection due to potential leaks that compromise sterility. The product was distributed nationwide and in Canada.
ICU Medical Inc is recalling 0.9% Sodium Chloride Injection bags because they may leak, compromising sterility. The recall covers lots distributed nationwide and in Canada.
ICU Medical is recalling 5% Dextrose Injection bags because they may leak, compromising sterility. The recall covers 267,288 bags distributed nationwide and in Canada.
ICU Medical is recalling 36 hemodynamic monitoring systems because the catheter thermal coil may continue operating while in Pause mode.
ICU Medical is recalling 250 pouches of 7-inch intravascular administration sets because they were manufactured with an incorrect spin collar.
ICU Medical is recalling 2,950 sterile 7-inch smallbore infusion sets because they were manufactured with an incorrect spin collar. The affected lots were distributed in the US, Canada, and Japan.
ICU Medical is recalling 100 pouches of 5-inch Smallbore Extension Sets because they were manufactured with an incorrect spin collar.
ICU Medical is recalling 11,500 smallbore extension sets manufactured with incorrect spin collars. The affected units were distributed in the US, Canada, and Japan.
ICU Medical is recalling 7,600 sterile intravascular administration sets because they were manufactured with an incorrect spin collar. The sets were distributed in the US, Canada, and Japan.
ICU Medical is recalling specific lots of sterile intravascular administration sets because they were manufactured with an incorrect spin collar.
ICU Medical Inc is recalling MedNet 6.1 and 6.21 software because it may alter piggyback medication settings without user notice.
ICU Medical is recalling specific IV administration sets because stopcocks may contain metallic burrs. The recall covers 24,475 units distributed in the US and Thailand.
ICU Medical is recalling 21,461 Plum 360 Infusion Systems because a software defect can prevent users from stopping the pump or restarting delivery under specific conditions.
ICU Medical Inc. is recalling 436,716 units of 0.9% Sodium Chloride Injection due to the presence of stainless steel particulate matter.
ICU Medical is recalling 68,559 Plum 360 Infusion Systems because the Connectivity Engine Module may disengage, causing the unit to shut down without an alarm and interrupting therapy.
ICU Medical is recalling 100 units of MicroClave extension set kits because the connection between the Female Luer and the NanoClave manifold may develop a leak.
ICU Medical is recalling 304 units of 18 cm Smallbore Extension Sets because the connection between the Female Luer and NanoClave manifold may leak.
ICU Medical is recalling 900 units of 10-inch smallbore extension sets because the connection between the Female Luer and the NanoClave manifold may develop a leak.
ICU Medical is recalling 70 units of Proximale Smallbore Extension Sets because the connection between the Female Luer and NanoClave manifold may develop a leak.
ICU Medical is recalling 120 units of smallbore extension sets because the connection between the Female Luer and NanoClave manifold may develop a leak.
ICU Medical is recalling 100 units of 10-inch smallbore extension sets because the connection between the Female Luer and the NanoClave manifold may develop a leak.
ICU Medical is recalling 6 units of 28 cm Smallbore Extension Sets because the connection between the Female Luer and NanoClave manifold may develop a leak.
ICU Medical is recalling 50 units of 28 cm Bifuse Extension Sets because the connection between the Female Luer and the NanoClave manifold may develop a leak.
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.