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Medline SYR120010Recalls & reported problems

Medline Industries, Inc. · SYRINGE, LUER LOCK, 20ML · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
17
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 30080196310221), received between Mar 18, 2024 and Sep 23, 2026 — classified as 17 malfunctions.

The most frequently reported specific device problem is “Contamination” (4 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

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 8 reportsApr 2024: 8 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 1 reportsOct 2026: 0 reports2024202520268
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Contamination4
  • Fluid/Blood Leak3
  • Break2
  • Crack2
  • Suction Problem2
  • Component Missing1
  • Detachment of Device or Device Component1
  • Gas/Air Leak1

Patient problems

  • No Clinical Signs, Symptoms or Conditions17

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

  • MalfunctionSep 23, 2026Material Integrity Problem

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50862973 ↗
  • MalfunctionApr 15, 2024Break; Break

    IT WAS REPORTED THAT THERE WERE MULTIPLE INCIDENTS WHERE THE SYRINGES WERE "BROKEN WHILE STILL IN THE PACKAGE, HAD HOLES IN THE TIPS, OR WERE TOO BRITTLE AND BROKE WHEN TRYING TO USE THEM".

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19111317 ↗
  • MalfunctionApr 3, 2024Break; Break

    IT WAS REPORTED THAT THE SYRINGE PLUNGER WAS "GOING SIDEWAYS AND BREAKING."

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19038473 ↗
  • MalfunctionApr 3, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

    IT WAS REPORTED THAT THE SYRINGE "MEASUREMENTS WERE OFF."

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19038472 ↗
  • MalfunctionApr 2, 2024Gas/Air Leak; Gas/Air Leak

    IT WAS REPORTED THAT AIR LEAKED INTO THE SYRINGE "FROM THE TOP OF THE PLUNGER."

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19016939 ↗
  • MalfunctionApr 1, 2024Suction Problem; Suction Problem

    IT WAS REPORTED THAT THE SYRINGE WAS "BACK DRAWING BLOOD BY ITSELF."

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19009706 ↗
  • MalfunctionApr 1, 2024Contamination; Contamination

    IT WAS REPORTED THAT "BLACK PARTICLES" WERE NOTED IN A MEDICATION VIAL AFTER THE SYRINGE DREW UP ITS CONTENTS.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19009703 ↗
  • MalfunctionApr 1, 2024Crack; Crack

    IT WAS REPORTED THAT THE SYRINGE SPLIT "AT THE BACK END AND THEN DOWN THE LENGTH" OF THE BARREL DURING USE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19009643 ↗
  • MalfunctionApr 1, 2024Fluid/Blood Leak; Loose or Intermittent Connection; Detachment of Device or Device Component; Fluid/Blood Leak; Loose or Intermittent Connection; Detachment of Device or Device Component

    IT WAS REPORTED THAT THE SYRINGE PLUNGER WAS "TOO LOOSE" AND IT "REFLUXES BACK UP THE IV LINE."

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19009640 ↗
  • MalfunctionMar 31, 2024Contamination; Contamination

    IT WAS REPORTED THAT HAIR WAS NOTED WITHIN THE SYRINGE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19009244 ↗
  • MalfunctionMar 30, 2024Contamination; Contamination

    IT WAS REPORTED THAT HAIR WAS NOTED WITHIN THE SYRINGE WHEN ITS PACKAGING WAS OPENED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19009149 ↗
  • MalfunctionMar 28, 2024Contamination; Contamination

    IT WAS REPORTED THAT HAIR WAS NOTED WITHIN THE SYRINGE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19001430 ↗
  • MalfunctionMar 28, 2024Crack; Crack

    IT WAS REPORTED THAT THE SYRINGE CRACKED DURING USE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19001398 ↗
  • MalfunctionMar 28, 2024Suction Problem; Component Missing; Suction Problem; Component Missing

    IT WAS REPORTED THAT THE SYRINGE WAS MISSING ITS PLUNGER.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19001396 ↗
  • MalfunctionMar 25, 2024Fluid/Blood Leak; Fluid/Blood Leak

    IT WAS REPORTED THAT LEAKAGE AROUND THE SYRINGE PLUNGER WAS NOTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18975567 ↗
  • MalfunctionMar 25, 2024Fluid/Blood Leak; Fluid/Blood Leak

    IT WAS REPORTED THAT THE SYRINGE WAS LEAKING AT THE TIP.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18968790 ↗
  • MalfunctionMar 18, 2024Mechanical Problem; Mechanical Problem

    IT WAS REPORTED THAT THE PLUNGER OF THE SYRINGE WAS DIFFICULT TO PUSH.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18921843 ↗

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