ICU Medical, Inc. 2025-07-23 Health serious FDA
Health · FDA · Recall #FDA-Z-2116-2025
SwabCap Disinfecting Cap for Needlefree Connectors: SwabSleeve, REF: SCXT3-5-2000; … Recall
Issued July 23, 2025 · ICU Medical, Inc.
In July 2025, ICU Medical, Inc. recalled the SwabCap Disinfecting Cap for Needlefree Connectors: SwabSleeve, REF: SCXT3-5-2000; …, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Due to a manufacturing issue, disinfecting cap for needle-free connectors may have an incomplete seal between the foil lid and plastic container, which may result in isopropyl alcohol evaporation from the sponge, which may result in inadequate disinfection.
What you should do
- 1 Stop using SwabCap Disinfecting Cap for Needlefree Connectors: SwabSleeve, REF: SCXT3-5-2000; … 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
- July 23, 2025
- Units affected
- Not reported
- Sold at
- Worldwide - US Nationwide distribution including in the states of TX, SD, ID, LA, IN, CO, OK, MO, MN, OR, AZ, NC, TN, VA, CA, IL, FL, MA, OH
- Recall number
- FDA-Z-2116-2025
- 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.