# FDA recall Z-2116-2025

> **ICU Medical, Inc.** · Class II · device recall initiated 2025-06-03.

## Product

SwabCap Disinfecting Cap for Needlefree Connectors: SwabSleeve, REF: SCXT3-5-2000;  SwabCap, 200-ct. Box, REF: SCXT3-2000

## Reason for recall

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.

## Distribution

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, MD, PA, NJ, NY, WA, GA, UT, MI, MS, AR, AL, NV, KS, IA, WV, HI, KY, NM and the country of CA.

## Key facts

- **Recall number:** Z-2116-2025
- **Recalling firm:** ICU Medical, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-06-03
- **Report date:** 2025-07-23

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** San Clemente, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2116-2025

## Citation

> AI Analytics. FDA recall Z-2116-2025. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-2116-2025. Source: US FDA. Licensed CC0.

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