Medline SYR101010Recalls & reported problems
Medline Industries, Inc. · SYRINGE, LUER LOCK, 1ML · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 12
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 30884389596313), received between Mar 7, 2024 and Apr 4, 2024 — classified as 12 malfunctions.
The most frequently reported specific device problem is “Mechanical Problem” (7 reports).
1 FDA recall record name this device's identifier, 1 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, 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
Recalls naming this device
- Apr 22, 2024Class IIOpen, Classified
It has been identified that testing documentation does not support that the syringes can successfully deliver accurate volumes across the full range of their claimed graduated capacity and may pose a risk to patient health.
Z-1937-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported problems
Device problems
- Mechanical Problem7
- Contamination2
- Detachment of Device or Device Component2
- Connection Problem1
- Fluid/Blood Leak1
- Material Too Soft/Flexible1
Patient problems
- No Clinical Signs, Symptoms or Conditions12
Recent adverse event reports
The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 4, 2024Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT THE SYRINGE PLUNGER WAS NOT "PUSHING THROUGH SMOOTHLY AND THEY SEEM TO GET STUCK."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19047532 ↗MalfunctionApr 4, 2024Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT THE SYRINGE PLUNGER WAS "STICKING" AND "DOES NOT MOVE SMOOTHLY."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19046452 ↗MalfunctionApr 4, 2024Fluid/Blood Leak; Detachment of Device or Device Component; Fluid/Blood Leak; Detachment of Device or Device Component
IT WAS REPORTED THAT THE BLACK STOPPER OF THE SYRINGE PLUNGER WAS "LOOSE AND UN-USABLE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19040699 ↗MalfunctionApr 1, 2024Material Too Soft/Flexible; Material Too Soft/Flexible
IT WAS REPORTED THAT THE SYRINGE PLUNGER WAS "FLEXIBLE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19016884 ↗MalfunctionApr 1, 2024Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT "THE RUBBER STOPPER IS GETTING CAUGHT" WITHIN THE SYRINGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19016846 ↗MalfunctionMar 29, 2024Connection Problem; Connection Problem
IT WAS REPORTED THAT NEEDLES "ARE NOT PROPERLY LOCKING" WITH THE SYRINGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19008737 ↗MalfunctionMar 29, 2024Contamination; Contamination
IT WAS REPORTED THAT "FIBER/HAIR" WAS NOTED WITHIN THE SYRINGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19008735 ↗MalfunctionMar 25, 2024Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT THE SYRINGE PLUNGER WAS HARD TO PUSH AND THAT IT "FELT STUCK."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18975566 ↗MalfunctionMar 24, 2024Contamination; Contamination
IT WAS REPORTED THAT HAIR WAS NOTED WITHIN THE SYRINGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18966404 ↗MalfunctionMar 18, 2024Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT SYRINGE PLUNGER BECOMES "STUCK" WHEN INJECTING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18922277 ↗MalfunctionMar 18, 2024Mechanical Problem; Detachment of Device or Device Component; Mechanical Problem; Detachment of Device or Device Component
IT WAS REPORTED THAT THE SYRINGE PLUNGER "LOCKS UP" AND THAT NEEDLE DETACHMENT OCCURRED WHEN APPLYING TOO MUCH PRESSURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18922155 ↗MalfunctionMar 7, 2024Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT "WHILE IN USE, THE PLUNGER WAS STICKING TO THE SYRINGE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18861588 ↗
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 13, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page