ICU Medical, Inc. is a leading manufacturer of medical devices and equipment. We provide innovative solutions for healthcare professionals.
ICU Medical identified two sequences of programming events and alarm interactions that may cause the user interface to become unresponsive.
ICU Medical, Inc. is a leading manufacturer of medical devices and equipment. We provide innovative solutions for healthcare professionals. Read more at govinfonow.com/recall/51803-icu-medical-inc-medical-devices.
Source Summary by GovInfoNow · govinfonow.com/recall/51803-icu-medical-inc-medical-devices · Updated August 10, 2026 · FDA enforcement record: FDA #Z-2129-2025
“ICU Medical, Inc. - Medical Devices.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/51803-icu-medical-inc-medical-devices. Based on FDA recall #Z-2129-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2129-2025%22&limit=1).
The FDA has classified an ongoing recall by ICU Medical, Inc. as Class I.
The provided text does not specify the hazard for this particular recall; it only lists hazards for other recalls involving ICU Medical or similar products.
ICU Medical, Inc. has 60 other recalls on record since 2017-06-15.
Check the product names field for specific medical devices. Ensure that the product is approved by regulatory bodies such as the FDA.
ICU Medical, Inc. is a well-known manufacturer of medical devices and equipment. Check their official website for more information.
Ensure that the specific medical device is approved by regulatory bodies such as the FDA before use.
Check the product documentation for safety instructions and warnings.
Where it was distributed
Distributed nationwide.
FDA distribution: “US Nationwide.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 33 days after the firm started it.
Dates from the agency record only; steps without a date are left out.
Contact the company's customer support or the FDA if you experience any issues with the product.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.