Excelsior 10011Recalls & reported problems
Medline Industries, Inc. · 0.9% Sodium Chloride Injection, USP · Class 2
All models of Excelsior (8)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00363807000032), received between Apr 4, 2024 and Sep 29, 2026 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Contamination” (1 report).
1 FDA recall record name this device's identifier, 1 still open.
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 16, 2026.
Reports received per month
Recalls naming this device
- Sep 11, 2025Open, Classified
Medline has identified a limited quantity of saline IV flush syringes that may not meet the required concentration of sodium chloride.
Z-0234-2026 · Root cause: Process control · Recall details · FDA record ↗
Most reported problems
Device problems
- Contamination1
- Difficult to Open or Remove Packaging Material1
- Improper or Incorrect Procedure or Method1
- Material Discolored1
- Packaging Problem1
- Structural Problem1
- Unexpected Color1
Patient problems
- No Clinical Signs, Symptoms or Conditions6
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Improper or Incorrect Procedure or Method
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50936039 ↗MalfunctionSep 23, 2026Packaging Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50873833 ↗MalfunctionSep 21, 2026Contamination
It was reported that ONE OF THE EACH FROM ONE CASE APPEARED TO BE DIRTY. SYRINGE HAD ORANGE CRYSTALS THROUGHOUT HOWEVER THE REMAINING OF CASE WAS NOT AFFECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50846142 ↗MalfunctionOct 16, 2024Unexpected Color; Unexpected Color
BROWNISH RESIDUE ON THE PLUNGER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20463648 ↗MalfunctionJul 3, 2024Material Discolored; Material Discolored
FOREIGN MATERIAL ON PLUNGER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19667645 ↗MalfunctionApr 4, 2024Structural Problem; Difficult to Open or Remove Packaging Material; Structural Problem; Difficult to Open or Remove Packaging Material
ACCORDING TO THE CUSTOMER, THE FLUSH SYRINGES ARE "ARE CUMBERSOME TO USE, DIFFICULT TO OPEN, AND THE GLIDE WHEN FLUSHING OFTEN STICKS" CAUSING THE NURSES TO "FREQUENTLY CONTAMINATE THEM AND HAVE TO GET NEW ONES".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19047337 ↗
Other Saline, vascular access flush devices
- BD PosiFlush 306553Becton, Dickinson And Company · Saline, vascular access flush89 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
- McKesson 191-MIS-1130Mckesson Medical-Surgical Inc. · Saline, Vascular Access Flush1 recall0 reports
- Halyard SS005Owens & Minor Distribution, Inc. · Saline, vascular access flush1 recall0 reports
- Halyard SS003Owens & 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 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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