MEDLINE INDUSTRIES, INC. SYR105205Recalls & reported problems
Medline Industries, Inc. · SYR W/NDLE,HYPODERM,LL,20GX1", 5ML · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10080196309535), received between Mar 25, 2024 and Apr 1, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 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
- Detachment of Device or Device Component2
- Fluid/Blood Leak1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 1, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE "BLACK STOPPER" OF THE SYRINGE PLUNGER DETACHED DURING USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19016238 ↗MalfunctionMar 25, 2024Fluid/Blood Leak; Detachment of Device or Device Component; Fluid/Blood Leak; Detachment of Device or Device Component
IT WAS REPORTED THAT THE NEEDLE BROKE OFF FROM THE SYRINGE INTO A BAG OF SOLUTION AND THAT LEAKAGE AT THE NEEDLE-SYRINGE SITE WAS NOTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18966665 ↗
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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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