SwabCap Disinfecting Cap for Needlefree Connectors: SwabSleeve — Class II medical device recall Z-2116-2025
Ongoing recall by ICU Medical, Inc., reported 2025-07-23, distributed nationwide. Due to a manufacturing issue, disinfecting cap for needle-free connectors may have an incomplete seal between
| Recall number | Z-2116-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | ICU Medical, Inc., San Clemente, CA, United States |
| Recall initiated | 2025-06-03 |
| Classified | 2025-07-11 |
| Reported by FDA | 2025-07-23 |
| Distributed | Nationwide (US) |
| Quantity | 1,445,600 |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 10887709097107, 20887709079162 |
| Lot numbers | SCXT3 |
| Model numbers | SCXT3, SCXT3-2000 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2116-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.