Excelsior E0100-01Recalls & reported problems
Medline Industries, Inc. · 0.9% Sodium Chloride Injection, USP · Class 2
Quick summary
This Medline Excelsior saline flush syringe is a prefilled syringe used to flush IV lines. The 24 reports mostly describe plungers cracking, breaking or coming apart and syringes leaking, with recent reports also mentioning mold contamination. The reports mention no deaths and 2 injuries. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 28
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 10363807100012), received between Jan 20, 2022 and Sep 30, 2026 — classified as 2 injuries, 26 malfunctions.
The most frequently reported specific device problem is “Break” (7 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Break7
- Mechanical Problem5
- Appropriate Device Problem Term/Code Not Available4
- Connection Problem2
- Contamination /Decontamination Problem2
- Crack2
- Contamination1
- Detachment of Device or Device Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions23
- Dyspnea2
- Insufficient Information2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Chest Pain1
- Nausea1
Recent adverse event reports
The 25 most recent of 28 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Physical Resistance/Sticking
It was reported that "The problem is; once the syringe is primed, the plunger still sticks. Which causes the physician to apply too much pressure to force the saline out when rinsing the eye after injections."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50945213 ↗MalfunctionSep 25, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50905114 ↗MalfunctionSep 25, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50904689 ↗MalfunctionSep 23, 2026Disconnection
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50873070 ↗MalfunctionFeb 2, 2026Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT A DEVICE WAS FOUND TO BE CONTAMINATED WITH MOLD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24242041 ↗MalfunctionJan 27, 2026Contamination /Decontamination Problem
MalfunctionOct 22, 2025Material Integrity Problem; Material Integrity Problem
ACCORDING TO THE FACILITY ON (B)(6) 2025 "REGISTERED NURSE ATTEMPTED TO FLUSH AN IV AND THE PLUNGER CRACKED, NO FORCE WAS USED, PATIENT WAS UNHARMED, AND THE RN USED ANOTHER FLUSH TO FINISH THE JOB".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23358705 ↗MalfunctionAug 11, 2025Material Puncture/Hole; Material Puncture/Hole
ACCORDING TO THE FACILITY, ON 7/9/2025, "HOLE IN PLUNGER NOTICED WHILE INJECTING" WITH SYRINGE. "PARTIAL AMOUNT OF PRODUCT WAS INJECTED INTO PORT." PER THE FACILITY, "RN OBTAINED A SECOND SYRINGE TO COMPLETE THE FLUSH PROCEDURE" AND PATIENT IS BEING MONITORED FOR INFECTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22777659 ↗MalfunctionJun 3, 2025Crack; Crack
IT WAS REPORTED THAT ON (B)(6) 2025 THE "PLUNGER" WAS "SPLINTERING AND CRACKING WHEN TRYING TO PUSH".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22131454 ↗MalfunctionDec 2, 2024Crack; Leak/Splash; Crack; Leak/Splash
IT WAS REPORTED THAT STARTING ON (B)(6) 2024 THERE WERE MULTIPLE INCIDENTS WHERE THE SALINE SYRINGES WERE FOUND TO BE "CRACKED AND LEAKING" PRIOR TO UTILIZATION ON A PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20824811 ↗MalfunctionSep 16, 2024Connection Problem; Connection Problem
IT WAS REPORTED THAT WHEN "PUSHING NACL INTO A BAXTER NEEDLESS CONNECTOR" ON (B)(6) 2024, THE "FLUSH CONNECTOR BECAME DISCONNECTED IN THE BAXTER ONE-LINE NEEDLESS PORT".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20232073 ↗MalfunctionMay 15, 2024Break; Break
IT WAS REPORTED THAT THE PLUNGER IS "BECOMING DISCONNECTED FROM THE SYRINGE UPON PULLING BACK WHEN OBTAINING BLOOD FROM PATIENT'S PORT/PICC".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19320700 ↗MalfunctionApr 24, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem
IT WAS REPORTED THAT THERE IS A DISCOLORATION OF THE SALINE INSIDE THE SYRINGE. IN ADDITION, THERE IS ORANGE RESIDUE ON INSIDE/BOTTOM OF THE SYRINGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19177005 ↗MalfunctionMar 19, 2024Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT THE CAP OF THE SALINE FLUSH SYRINGE WAS DIFFICULT TO REMOVE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18937357 ↗MalfunctionMar 19, 2024Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT THE CAP OF THE SALINE FLUSH SYRINGE WAS DIFFICULT TO REMOVE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18937353 ↗MalfunctionMar 19, 2024Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT THE CAP OF THE SALINE FLUSH SYRINGE WAS DIFFICULT TO REMOVE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18937350 ↗MalfunctionMar 19, 2024Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT THE CAP OF THE SALINE FLUSH SYRINGE WAS DIFFICULT TO REMOVE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18937349 ↗MalfunctionMar 13, 2024Contamination; Contamination
IT WAS REPORTED THAT "DEBRIS" WAS NOTED WITHIN THE PRE-FILLED SYRINGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18896907 ↗MalfunctionMar 8, 2024Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT THE "RUBBER" OF THE SYRINGE PLUNGER IS STICKING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18865246 ↗MalfunctionMar 8, 2024Connection Problem; Connection Problem
IT WAS REPORTED THAT THE PRE-FILLED SALINE FLUSH SYRINGE WOULD NOT FULLY THREAD ONTO A STOPCOCK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18865239 ↗MalfunctionMar 7, 2024Break; Break
IT WAS REPORTED THAT WHEN ATTEMPTING TO "FLUSH AN OCCLUDED PICC" THE SYRINGE BROKE "WHERE THE HUB ATTACHES TO THE CATHETER".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18856948 ↗MalfunctionMar 6, 2024Break; Break
IT WAS REPORTED THAT WHILE "FLUSHING PICC LINE" THE "WING ON THE FLUSH SNAPPED OFF".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18852379 ↗MalfunctionFeb 7, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT A PATIENT EXPERIENCED A "NEGATIVE REACTION."
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Chest Pain; Nausea
MAUDE report 18659097 ↗InjuryOct 23, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
ACCORDING TO THE FACILITY THE PATIENT WAS GIVEN "2L OF OXYGEN NASAL CANNULA" AFTER "BOTH LUMENS WERE FLUSHED WITH THE PRE-FILLED SYRINGE TO KEEP CATHETER PATENT" AND PATIENT COMPLAINED OF BEING SHORT OF BREATH AND THEIR CHEST BEING HEAVY.
Patient problems: Dyspnea
MAUDE report 17986585 ↗InjuryOct 23, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
ACCORDING TO THE FACILITY THE PATIENT WAS GIVEN "2L OF OXYGEN NASAL CANNULA" AFTER "BOTH LUMENS WERE FLUSHED WITH THE PRE-FILLED SYRINGE TO KEEP CATHETER PATENT" AND PATIENT COMPLAINED OF BEING SHORT OF BREATH AND THEIR CHEST BEING HEAVY.
Patient problems: Dyspnea
MAUDE report 17986345 ↗
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
- McKesson 191-MIS-1130Mckesson Medical-Surgical Inc. · Saline, Vascular Access Flush1 recall0 reports
- Halyard SS005Owens & Minor Distribution, Inc. · Saline, vascular access flush1 recall0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.