Medline EMZCCS10500Recalls & reported problems
Medline Industries, Inc. · SYRINGE, 10ML, SODIUM CHLORIDE · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00363807011175), received between Feb 9, 2026 and May 15, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Air/Gas in Device” (2 reports).
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
- Air/Gas in Device2
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 15, 2026Break
WHEN CONNECTING THE STERILE FLUSH FROM THE ACCESS KIT TO THE INJECTION CAP, THE TIP OF THE SYRINGE BROKE OFF IN THE INJECTION CAP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25184531 ↗MalfunctionFeb 10, 2026Air/Gas in Device
IT WAS REPORTED THAT "BUBBLES HAVE BEEN NOTED TO BE LEFT IN THE SYRINGE AFTER FOLLOWING MEDLINE'S INSTRUCTIONS ON HOW TO PRIME SYRINGE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24309463 ↗MalfunctionFeb 9, 2026Air/Gas in Device
ACCORDING TO THE FACILITY, BUBBLES WERE NOTED TO REMAIN IN THE SYRINGE AFTER FOLLOWING MEDLINE'S INSTRUCTIONS FOR PRIMING SYRINGES. THE FACILITY REPORTED THAT REMOVING ALL BUBBLES WAS NOT EFFECTIVE AND THAT THE BUBBLES UNABLE TO BE EXPELLED WERE LARGER THAN PIN SIZE. THE FACILITY FURTHER REPORTED THAT SIGNIFICANT EFFORT WAS REQUIRED TO EXPEL THE BUBBLES, RESULTING IN THE WASTING OF APPROXIMATELY 1-3 ML OF SALINE AT TIMES. THE FACILITY STATED THAT THE SYRINGES WITH BUBBLES WERE NOT USED AND THAT STAFF OBTAINED ALTERNATIVE PREFILLED SYRINGES FROM PAR WALLS. THE REPORTED SYRINGES DID NOT REACH THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24292343 ↗
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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