ExcelsiorRecalls & reported problems across all models

We found 8 models of Excelsior by Medline Industries, Inc. in the FDA's device registry (GUDID). Together they are named in 47 adverse event reports in the FDA's MAUDE database, received between Oct 11, 2017 and Sep 30, 2026 — classified as 3 injuries, 44 malfunctions.

The most frequently reported specific device problem is “Break” (7 reports).

3 FDA recall records name at least one of these models by its device identifier, 3 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Excelsior recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. 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 ↗

2. Jun 16, 2025Open, Classified

   SwabFlush syringes are affected by the ICU Medical recall of their SwabCap Disinfecting Cap due to a manufacturing issue which affects the seal between the foil lid and plastic container of the Swab Cap. The issue may result in a reduced level of disinfection of the luer access valve, potentially resulting in patient infection/sepsis.

   Z-2199-2025 · Root cause: Process control · Recall details · FDA record ↗

3. May 25, 2022Open, Classified

   Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.

   Z-1596-2022 · Root cause: Environmental control · Recall details · FDA record ↗

Most reported Excelsior problems

Excelsior models

8 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Excelsior 10011

  Saline, vascular access flush
  1 recall6 reports
• Excelsior E0103-01

  Saline, vascular access flush
  1 recall1 report
• Excelsior 60051

  Heparin, vascular access flush
  1 recall0 reports
• Excelsior E0100-01

  Saline, vascular access flush
  28 reports
• Excelsior E0100-30

  Saline, vascular access flush
  7 reports
• Excelsior 10051

  Saline, vascular access flush
  2 reports
• Excelsior E0100-55

  Saline, vascular access flush
  2 reports
• Excelsior 711-600

  Saline, vascular access flush
  1 report

Recent Excelsior adverse event reports

The 15 most recent reports across all models, 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 29, 2026Improper or Incorrect Procedure or Method

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50936039 ↗
• 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, 2026Packaging Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50873833 ↗
• MalfunctionSep 23, 2026Disconnection

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50873070 ↗
• MalfunctionSep 23, 2026Unsealed Device Packaging

  It was reported that Posiflush we received have no plastic bag covering them therefore making them non-sterile.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50868754 ↗
• 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 ↗
• MalfunctionAug 21, 2026Insufficient Device Problem Information

  Patient problems: Dry Mouth; No Clinical Signs, Symptoms or Conditions

  MAUDE report 50379296 ↗
• 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

  MOLDY SYRINGE.

  Patient problems: Insufficient Information

  MAUDE report 24190978 ↗
• 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 18, 2025Short Fill; Short Fill

  IT WAS REPORTED THAT THE SYRINGE WAS FILLED TO "1 ML INSTEAD OF 2.5 ML".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22835768 ↗
• 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 12, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE FACILITY ON 05/23/2025 THEY WERE "PREPARING FOR INJECTION TO PATIENT'S CENTRAL LINE" THE SALINE FLUSH WAS MISSING THE SALINE FLUID.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22196506 ↗

Other Medline Industries, Inc. products

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