Excelsior recallZ-2199-2025 · MEDLINE INDUSTRIES, LP - Northfield · initiated Jun 16, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from MEDLINE INDUSTRIES, LP - Northfield or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was 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.
FDA root cause category: Process control
What the company is doing
On June 16, 2025, the firm notified customers of the affected product. Customers were instructed to destroy the affected product for credit.
Recall details
- Recall number
- Z-2199-2025
- Status
- Open, Classified
- Initiated by the company
- Jun 16, 2025
- Posted by the FDA
- Jul 30, 2025
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Quantity
- 1,427,100 eaches
- Product code
- QBP
- FDA submissions
- K130975
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada and Panama.
Product description
SwabFlush Prefilled Syringe with ICU Medical SwabCaps, 10mL Model no. EMZE010301
Code information (models, lots, serial numbers)
UDI-DI 00363807103016 (ea) 10363807103013 (box) 20363807103010 (case) Lots 3144609 3144857 3144886 3144967 3145090 3145186
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Excelsior E0103-01Medline Industries, Inc. · Saline, vascular access flush1 recall1 report
Product lines
Other devices under the same FDA submission
2 devices cleared under K130975 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- SwabSleeve™ SCXT3-5-2000Icu Medical, Inc. · Cap, device disinfectant1 recall0 reports
- Excelsior 711-600Medline Industries, Inc. · Saline, vascular access flush1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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