Medline SYR100185Recalls & reported problems
Medline Industries, Inc. · NEEDLE,18GX1.0",REG,BEVEL,ST · Class 2
- Adverse event reports
- 10
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 30080196304947), received between Sep 9, 2026 and Sep 24, 2026 — classified as 10 malfunctions.
The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (3 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Improper or Incorrect Procedure or Method3
- Off-Label Use3
- Particulates3
- Activation Failure1
- Connection Problem1
- Material Fragmentation1
- Use of Device Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions10
Recent adverse event reports
The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 24, 2026Improper or Incorrect Procedure or Method
It was reported that "The 18-gauge needles supplied are coring vials." "Multiple technicians experienced coring vials while compounding."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50886630 ↗MalfunctionSep 18, 2026Off-Label Use
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50828437 ↗MalfunctionSep 17, 2026Off-Label Use
It was reported that the hypodermic needle was reportedly coring out when used on medication viles leaving small remnants in the medication.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50806632 ↗MalfunctionSep 17, 2026Particulates; Use of Device Problem
It was reported that particulates from a medication core leaked into the medication of a multi-dose vial.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50803471 ↗MalfunctionSep 17, 2026Material Fragmentation
It was reported that "Our staff are reporting multiple events of coring when they use these needles to draw up solutions in the IV room." "Coring" is when part of the rubber stopper on a drug vial dislodges from the core, or a piece of the stopper is sheared off, and goes into the drug liquid in the vial.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50797370 ↗MalfunctionSep 14, 2026Off-Label Use
It was reported that "When inserting the needle into the medication, the rubber top is breaking and going into the solution bottle."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50752730 ↗MalfunctionSep 13, 2026Improper or Incorrect Procedure or Method
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50746950 ↗MalfunctionSep 12, 2026Connection Problem; Activation Failure
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50746795 ↗MalfunctionSep 12, 2026Particulates; Improper or Incorrect Procedure or Method
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50744744 ↗MalfunctionSep 9, 2026Particulates
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50699126 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.