SwabFlush Prefilled Syringe with ICU Medical SwabCaps — Class II medical device recall Z-2199-2025
Ongoing recall by MEDLINE INDUSTRIES, LP - Northfield, reported 2025-08-06, distributed nationwide. SwabFlush syringes are affected by the ICU Medical recall of their SwabCap Disinfecting Cap due to a manufactu
| Recall number | Z-2199-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | MEDLINE INDUSTRIES, LP - Northfield, Northfield, IL, United States |
| Recall initiated | 2025-06-16 |
| Classified | 2025-07-30 |
| Reported by FDA | 2025-08-06 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, PA |
| Quantity | 1,427,100 eaches |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 00363807103016, 10363807103013, 20363807103010 |
| Lot numbers | 3144609, 3144857, 3144886, 3144967, 3145090, 3145186 |
| Model numbers | EMZE010301 |
Product
SwabFlush Prefilled Syringe with ICU Medical SwabCaps, 10mL Model no. EMZE010301
Reason for recall
SwabFlush syringes are affected by the ICU Medical recall of their SwabCap Disinfecting Cap due to a manufacturing issue which affects the seal between the foil lid and plastic container of the Swab Cap. The issue may result in a reduced level of disinfection of the luer access valve, potentially resulting in patient infection/sepsis.
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-2199-2025. 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.