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
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 ↗
Other Syringe, piston devices
- BD Luer-Lok 309657Becton, Dickinson And Company · Syringe, piston1,266 reports
- BD Luer-Lok 309653Becton, Dickinson And Company · Syringe, piston948 reports
- BD Luer-Lok 309628Becton, Dickinson And Company · Syringe, piston862 reports
- N/A 302995Becton, Dickinson And Company · Syringe, piston1 recall537 reports
- BD Plastipak Syringe 300865Becton, Dickinson And Company · Syringe, piston515 reports
- N/A 302830Becton, Dickinson And Company · Syringe, piston462 reports
- N/A 302832Becton, Dickinson And Company · Syringe, piston424 reports
- BD Ultra-Fine 328468Becton, Dickinson and Company Inc · Syringe, piston323 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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