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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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High RiskFDA Device
Medical Devices

SwabFlush Prefilled Syringes Recalled for Infection and Sepsis Risks

Agency Publication Date: July 30, 2025
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Summary

Medline Industries is recalling 1,427,100 units of SwabFlush Prefilled Syringes with ICU Medical SwabCaps (10mL) because the disinfecting caps may have a faulty seal. This manufacturing defect involves the seal between the foil lid and plastic container, which can prevent the cap from properly disinfecting medical access valves. While no injuries have been reported, this issue could lead to serious medical complications for patients.

Risk

A compromised seal on the disinfecting cap reduces the level of sterilization for luer access valves, which can directly lead to serious patient infections or sepsis. This risk is especially high for patients requiring frequent intravenous access.

What You Should Do

  1. The recalled products are SwabFlush Prefilled Syringes with ICU Medical SwabCaps, 10mL (Model EMZE010301) with lot numbers 3144609, 3144857, 3144886, 3144967, 3145090, or 3145186.
  2. Stop using the recalled product immediately.
  3. Identify affected products by checking for UDI-DI codes 00363807103016 (individual syringe), 10363807103013 (box), or 20363807103010 (case) and the lot numbers listed above.
  4. Contact Medline Industries, LP or your medical distributor to arrange for the return, replacement, or correction of the affected units.
  5. If you are a healthcare provider and suspect a patient has been harmed by this device, report the incident to your facility's safety officer and the FDA.
  6. Call the FDA Consumer Complaint hotline at 1-888-463-6332 (1-888-INFO-FDA) for additional assistance.

Your Remedy Options

๐Ÿ“‹Other Action

Correction or Replacement

How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: SwabFlush Prefilled Syringe with ICU Medical SwabCaps (10mL)
Variants: 10mL
Model / REF:
EMZE010301
Lot Numbers:
3144609
3144857
3144886
3144967
3145090
3145186
UDI:
00363807103016
10363807103013
20363807103010

Recall #: Z-2199-2025; Includes individual eaches, boxes, and cases.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97169
Status: Active
Manufacturer: MEDLINE INDUSTRIES, LP - Northfield
Sold By: Medical distributors; Healthcare facilities
Manufactured In: United States
Units Affected: 1,427,100 eaches
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.