CLASS II ONGOING Device recall · Reported 6 Aug 2025 · FDA Enforcement Report
SwabFlush Prefilled Syringe with ICU Medical SwabCaps recalled
Medline Industries LP - Northfield is recalling SwabFlush Prefilled Syringe with ICU Medical SwabCaps, distributed nationwide in the US. The recall was initiated on 16 Jun 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2199-2025
- FDA event ID
- 97169
- Recalling firm
- Medline Industries LP - Northfield, Northfield, IL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 16 Jun 2025
- FDA classified
- 30 Jul 2025
- Reported
- 6 Aug 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Foreign Material
- Device type
- Syringes & Needles
Timeline
| 16 Jun 2025 | Recall initiated by company | |
| 30 Jul 2025 | Classified by FDA | +44 days |
| 6 Aug 2025 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
SwabFlush Prefilled Syringe with ICU Medical SwabCaps, 10mL Model no. EMZE010301
Where it was distributed
Worldwide distribution - US Nationwide and the countries of Canada and Panama.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
UDI-DI 00363807103016 (ea) 10363807103013 (box) 20363807103010 (case) Lots 3144609 3144857 3144886 3144967 3145090 3145186
Where was it sold?
Worldwide distribution - US Nationwide and the countries of Canada and Panama.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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