MEDLINE EMZE010001Recalls & reported problems
Medline Industries, Inc. · SYRINGE, 10ML SALINE IN 10ML · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 30888277675814), received between Sep 11, 2018 and Sep 22, 2026 — classified as 3 injuries, 1 malfunction.
The most frequently reported specific device problem is “Contamination” (1 report).
1 other recall cover devices cleared under the same FDA submission (K173348); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
- Contamination1
- Insufficient Device Problem Information1
Patient problems
- Unspecified Infection3
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 22, 2026Contamination
It was reported that "CONTAMINATED ITEM" and "SYRINGE LOOKS TO HAVE DIRT LIKE SUBSTANCE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50854898 ↗InjurySep 11, 2018Insufficient Device Problem Information
IT WAS REPORTED THAT THE PATIENT WAS DIAGNOSED WITH AN UNIDENTIFIED INFECTION AFTER USE OF THE SALINE SYRINGE.
Patient problems: Unspecified Infection
MAUDE report 7864973 ↗InjurySep 11, 2018Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT WAS DIAGNOSED WITH AN UNIDENTIFIED INFECTION AFTER USE OF THE SALINE SYRINGE.
Patient problems: Unspecified Infection
MAUDE report 7864890 ↗InjurySep 11, 2018Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT WAS DIAGNOSED WITH AN UNIDENTIFIED INFECTION AFTER USE OF THE SALINE SYRINGE.
Patient problems: Unspecified Infection
MAUDE report 7864560 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K173348. One submission often covers many models, so check the product and lot details in each record.
- Z-0234-2026 · Sep 11, 2025 · Open, ClassifiedExcelsior Medical, 0.9% Sodium Chloride Injection, USP - 10 mL Fill, Item Number EMZ111240. Prefilled saline flush syringes
Other Saline, vascular access flush devices
- BD PosiFlush 306553Becton, Dickinson And Company · Saline, vascular access flush89 reports
- Excelsior 10011Medline Industries, Inc. · Saline, vascular access flush1 recall6 reports
- ARROW IPN927748Teleflex Incorporated · Saline, vascular access flush1 recall4 reports
- Halyard SS010Owens & Minor Distribution, Inc. · Saline, vascular access flush1 recall2 reports
- Normal Saline IV Flush Syringe 10mL in 12mL syringeMedefil, Inc. · Saline, Vascular Access Flush1 recall1 report
- Excelsior E0103-01Medline Industries, Inc. · Saline, vascular access flush1 recall1 report
- Halyard SS003Owens & Minor Distribution, Inc. · Saline, vascular access flush1 recall0 reports
- Halyard SS005Owens & Minor Distribution, Inc. · Saline, vascular access flush1 recall0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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