Use cautionMedical device recall · FDA · Published June 16, 2025
Medline SwabFlush Syringes Recall: Risk of Patient Infection from Poor Disinfection
Medline recalls SwabFlush Prefilled Syringes with ICU Medical SwabCaps due to a seal issue that may reduce disinfection, risking patient infection. Affected units include specific model numbers and lots.
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.
Take action
Contact the company
📍Recalling firmMEDLINE INDUSTRIES, LP - Northfield3 Lakes Dr · Northfield, IL 60093-2753
“Medline SwabFlush Syringes Recall: Risk of Patient Infection from Poor Disinfection.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/52041-medline-swabflush-syringes-recall-risk-of-patient-infection-from-poor. Based on FDA recall #Z-2199-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2199-2025%22&limit=1).
The FDA announced on June 16, 2025, that Medline Industries LP is recalling SwabFlush Prefilled Syringes with ICU Medical SwabCaps due to a manufacturing issue affecting the cap seal. This defect may result in reduced disinfection of the luer access valve, potentially causing patient infection or sepsis.
How to tell if you have it
Brand: Medline
Product: SwabFlush Prefilled Syringe with ICU Medical SwabCaps, 10mL
The recall addresses a manufacturing issue affecting the seal between the foil lid and plastic container of the SwabCap Disinfecting Cap. This issue may result in a reduced level of disinfection of the luer access valve, potentially resulting in patient infection/sepsis.
Context
GovInfoNow's records show MEDLINE INDUSTRIES, LP - Northfield has 119 other recalls on record since 2021-10-22. Recent Medline recalls include medical kits with light failure in intubation trays (2025-07-25), Foley Tray Kits with incorrect labeling risk (2025-07-23), and reprocessed St. Jude Catheters that may contain particulates (2025-07-14). Other recent recalls of similar products include Medline Convenience Kits Recall: Risk of Sterile Packaging Breach (2026-06-12), Medline Convenience Kits Recall: Risk of Microbial Contamination from Packaging Wrinkles (2026-06-12), and Medline Medical Kits Recall: Open Seal Risk in BD ChloraPrep Swabsticks (2025-12-24).
How to tell if you have this one
Check for model number EMZE010301 on the syringe. Affected units include specific lot numbers: 3144609, 3144857, 3144886, 3144967, 3145090, 3145186.
Brand
Medline
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Details
Identify the model number (EMZE010301) and lot numbers (3144609, 3144857, etc.) on the syringe packaging.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Worldwide distribution - US Nationwide and the countries of Canada and Panama.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 51 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-2199-2025 (June 16, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2199-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.