Medline SYRS103255Recalls & reported problems
Medline Industries, Inc. · SAFETY SYRINGE, 3ML 25GX1" · Class 2
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 30888277222599), received between Mar 11, 2024 and Sep 11, 2026 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Recalls naming this device
- May 9, 2024Open, Classified
Products in distribution were found by FDA to be to be substantially different from the current cleared 510(k)s with a major change or modification to the device s intended use.
Z-3074-2024 · Root cause: Other · FDA record ↗
Most reported problems
Device problems
- Detachment of Device or Device Component2
- Break1
- Connection Problem1
- Contamination1
- Infusion or Flow Problem1
- Material Twisted/Bent1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 11, 2026Break; Material Twisted/Bent
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50733978 ↗MalfunctionApr 6, 2024Contamination; Contamination
IT WAS REPORTED THAT "PARTICLES" WERE NOTED WITHIN THE SYRINGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19056516 ↗MalfunctionMar 25, 2024Connection Problem; Detachment of Device or Device Component; Connection Problem; Detachment of Device or Device Component
IT WAS REPORTED THAT NEEDLES DETACH FROM THE SYRINGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18976246 ↗MalfunctionMar 25, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE SYRINGE WAS "FLIMSY" AND THAT "NEEDLES ARE NOT LOCKING ONTO" THE DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18976244 ↗MalfunctionMar 11, 2024Infusion or Flow Problem; Infusion or Flow Problem
IT WAS REPORTED THAT WHEN MEDICATION IS DRAWN INTO THE SYRINGE, IT CANNOT BE PUSHED BACK OUT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18881921 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.