ICU Medical, Inc. 2025-11-05 Health serious FDA
Health · FDA · Recall #FDA-Z-0348-2026
ICU Medical ChemoLock Closed Vial Spike w/Skirt, 5 Units REF: CL-80S-5 Recall
Issued November 5, 2025 · ICU Medical, Inc.
In November 2025, ICU Medical, Inc. recalled the ICU Medical ChemoLock Closed Vial Spike w/Skirt, 5 Units REF: CL-80S-5, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
What you should do
- 1 Stop using ICU Medical ChemoLock Closed Vial Spike w/Skirt, 5 Units REF: CL-80S-5 right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact ICU Medical, Inc. to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- ICU Medical, Inc.
- Category
- Health
- Recall date
- November 5, 2025
- Units affected
- Not reported
- Sold at
- Worldwide distribution: US (Nationwide) including states of: AK AL AR AZ CA CO CT DE FL GA IA ID IL KS KY LA MA MD MI MN MS MT NC NE NJ NM N
- Recall number
- FDA-Z-0348-2026
- Made in
- United States
- Issuing agency
- FDA
In context
- ICU Medical, Inc. has 5 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 691st Health recall we've logged in 2025.