MEDLINE SSN100187Recalls & reported problems
Medline Industries, Inc. · NEEDLE,HYPODERM,SAFETY,18GX1.5 · Class 2
- Adverse event reports
- 13
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10193489031874), received between Jun 28, 2024 and Sep 30, 2026 — classified as 13 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component7
- Off-Label Use2
- Packaging Problem2
- Particulates2
- Insufficient Device Problem Information1
Patient problems
- No Clinical Signs, Symptoms or Conditions10
- Needle Stick/Puncture3
- Hemorrhage/Blood Loss/Bleeding1
Recent adverse event reports
The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949053 ↗MalfunctionSep 30, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50948438 ↗MalfunctionSep 30, 2026Particulates
It was reported that "The Medline sure-snap needles are leaving bits of the "stopper" inside the lidocaine bottles when we draw it up."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50946080 ↗MalfunctionSep 25, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50906215 ↗MalfunctionSep 17, 2026Particulates; Off-Label Use
It was reported that "These needles have been coring the tops of medication vials, resulting in tiny plastic particles being released into the vial or the drawing syringe."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50801901 ↗MalfunctionSep 17, 2026Detachment of Device or Device Component
It was reported that "the plastic caps coming off" and "safety device not attached to the needle. Malfunction when opening."
Patient problems: Hemorrhage/Blood Loss/Bleeding; Needle Stick/Puncture
MAUDE report 50797332 ↗MalfunctionSep 16, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50786007 ↗MalfunctionSep 14, 2026Packaging Problem
Patient problems: Needle Stick/Puncture
MAUDE report 50761827 ↗MalfunctionSep 14, 2026Detachment of Device or Device Component
It was reported that "The plastic caps fall off when they are opened and can fall off prior to giving the injections."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50754506 ↗MalfunctionSep 12, 2026Packaging Problem
Patient problems: Needle Stick/Puncture
MAUDE report 50746876 ↗MalfunctionSep 12, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50744735 ↗MalfunctionSep 9, 2026Off-Label Use
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50692802 ↗MalfunctionJun 28, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
CAPS ARE NOT SECURE WHEN OPENING THE THE NEEDLE GETS EXPOSED. THIS OCCURRED ON THREE SEPARATE OCCASIONS AND ON ALL 3, THE NEEDLE WAS TOUCHED BY THE PROVIDER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19639993 ↗
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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.