ICU Medical, Inc. is a medical device manufacturer registered with the FDA. This page provides information on their medical device registrations.
Due to a manufacturing defect from the battery supplier, affected batteries may experience a loss of capacity earlier in the battery lifecycle than expected and overall battery runtime may decrease earlier in the battery lifecycle than expected.
ICU Medical, Inc. is a medical device manufacturer registered with the FDA. This page provides information on their medical device registrations.
This is a low-risk registration for a medical device manufacturer. ICU Medical, Inc. is a legitimate medical device manufacturer registered with the FDA.
All users of medical devices from ICU Medical, Inc.
Check the product names and product codes on the device itself to ensure it matches the registered products.
Verify the product name and product code on the device matches the registered products listed on the FDA website.
Go to the FDA's website and search for the product name and product code to confirm it is registered.
Yes, ICU Medical, Inc. is a legitimate medical device manufacturer registered with the FDA.
Check the product name and product code on the device against the FDA's registered products.
We’ve drafted a message you can send ICU Medical, Inc. to request your refund or repair — edit it as you like.
Subject: Recall Z-2447-2024 — ICU Medical, Inc. ICU Medical, Inc. Hello, I own a ICU Medical, Inc. that is covered by recall Z-2447-2024 from ICU Medical, Inc.. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
