Medline SYR110010Recalls & reported problems
Medline Industries, Inc. · SYRINGE, LUER LOCK, 10ML · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 23
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 30080196310191), received between Feb 20, 2024 and Sep 30, 2026 — classified as 23 malfunctions.
The most frequently reported specific device problem is “Suction Problem” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Suction Problem7
- Contamination5
- Detachment of Device or Device Component3
- Connection Problem2
- Decrease in Suction2
- Leak/Splash2
- Break1
- Device Contamination with Chemical or Other Material1
Patient problems
- No Clinical Signs, Symptoms or Conditions19
- Insufficient Information4
Recent adverse event reports
The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Break
It was reported that "I have a box of 10cc syringes that have some damaged ones, it looks like about 20 ea" and "It's the side of the syringe that is broken, they are still in the package but you can see the side handle broken."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50948551 ↗MalfunctionDec 6, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT "THERE HAVE BEEN OCCASIONS" AFTER THEY DRAW UP "SALINE" AND "CONTRAST" INTO THE SYRINGE, THAT A "BLACK" PARTICULATE IS VISUALIZED INSIDE THE SYRINGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20860643 ↗MalfunctionJul 2, 2024Leak/Splash; Leak/Splash
IT WAS REPORTED ON (B)(6) 2024 THE SYRINGE WAS LEAKING "BELOW RUBBER PIECE IN SYRINGE" AND LEAKING "BELOW THE PLUNGER".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19656712 ↗MalfunctionApr 12, 2024Suction Problem; Suction Problem
MalfunctionApr 12, 2024Suction Problem; Suction Problem
MalfunctionApr 11, 2024Decrease in Suction; Decrease in Suction
MalfunctionApr 9, 2024Decrease in Suction; Decrease in Suction
LACK OF SUCTION WHEN DRAWING BLOOD INTO SYRINGE.
Patient problems: Insufficient Information
MAUDE report 19073790 ↗MalfunctionApr 4, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem
IT WAS REPORTED THAT THE MARKINGS ON THE SYRINGE WERE "RUBBING OFF."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19047533 ↗MalfunctionApr 4, 2024Contamination; Contamination
IT WAS REPORTED THAT A "WHITE CLOUDY FILM" WAS NOTED ON THE SYRINGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19040696 ↗MalfunctionApr 4, 2024Contamination; Contamination
IT WAS REPORTED THAT "BLACK PARTICLES" WERE NOTED WITHIN THE SYRINGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19039038 ↗MalfunctionApr 1, 2024Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT THE SYRINGE HANDLE WAS "LOOSE AND RATTLES" AND THAT THE BLACK PLUNGER STOPPER "DOES NOT GIVE GOOD CONSISTENT RESISTANCE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19016849 ↗MalfunctionMar 31, 2024Contamination; Contamination
IT WAS REPORTED THAT A "LIGHT BROWN FLAKE" WAS NOTED WITHIN A SYRINGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19009241 ↗MalfunctionMar 28, 2024Suction Problem; Suction Problem
IT WAS REPORTED THAT THE SYRINGE WAS NOTED TO HAVE "A LACK OF VACUUM."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19001534 ↗MalfunctionMar 28, 2024Gas/Air Leak; Gas/Air Leak
IT WAS REPORTED THAT THE SYRINGE PLUNGER IS "NOT ATTACHED PROPERLY" AND RESULTED IN AIR LEAKAGE INTO THE BARREL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19001397 ↗MalfunctionMar 24, 2024Contamination; Contamination
IT WAS REPORTED THAT FOREIGN PARTICULATE WAS NOTED WITHIN THE SYRINGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18966554 ↗MalfunctionMar 24, 2024Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT A SMALL PIECE OF SYRINGE RUBBER SEAL TORE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18966434 ↗MalfunctionMar 24, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE RUBBER TIP OF THE SYRINGE PLUNGER DETACHED AND WAS "STICKING TO THE BOTTOM OF THE BARREL."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18966407 ↗MalfunctionMar 18, 2024Suction Problem; Detachment of Device or Device Component; Suction Problem; Detachment of Device or Device Component
IT WAS REPORTED THAT THE BLACK STOPPER OF THE SYRINGE PLUNGER DETACHED AND THAT THE SYRINGE HAD INADEQUATE SUCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18922088 ↗MalfunctionMar 18, 2024Suction Problem; Detachment of Device or Device Component; Suction Problem; Detachment of Device or Device Component
IT WAS REPORTED THAT THE SYRINGE DID NOT CREATE A SUCTION AND THAT NEEDLE DETACHMENT OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18922029 ↗MalfunctionMar 18, 2024Leak/Splash; Connection Problem; Leak/Splash; Connection Problem
IT WAS REPORTED THAT THE PLUNGER OF THE SYRINGE WAS LOOSE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18921867 ↗MalfunctionMar 18, 2024Suction Problem; Suction Problem
IT WAS REPORTED THAT A "LACK OF VACUUM" WAS NOTED WITH THE SYRINGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18921817 ↗MalfunctionMar 8, 2024Suction Problem; Connection Problem; Suction Problem; Connection Problem
IT WAS REPORTED THAT THE SYRINGE IS "NOT AIRTIGHT" AND THAT NEEDLE DETACHMENT OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18865273 ↗MalfunctionFeb 20, 2024Contamination; Contamination
IT WAS REPORTED THAT RED PARTICULATE WAS IDENTIFIED AT THE BOTTOM OF THE SYRINGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18743449 ↗
Other Syringe, piston devices
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- 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
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- 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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