MEDLINE SSN100225Recalls & reported problems
Medline Industries, Inc. · NEEDLE,HYPODERM,SAFETY,22GX1 · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10193489031935), received between Sep 14, 2026 and Sep 29, 2026 — classified as 6 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component2
- Fluid/Blood Leak2
- Connection Problem1
- Difficult to Open or Close1
- Disconnection1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- Insufficient Information1
- Needle Stick/Puncture1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Difficult to Open or Close
Patient problems: Needle Stick/Puncture
MAUDE report 50934683 ↗MalfunctionSep 22, 2026Detachment of Device or Device Component
It was reported that THE PLASTIC SAFETY COVER FOR THE NEEDLES IS NOT REMAINING ON THE NEEDLE WHEN PLACED ONTO THE USED NEEDLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50854794 ↗MalfunctionSep 21, 2026Disconnection; Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50841227 ↗MalfunctionSep 16, 2026Connection Problem
It was reported that "They are not creating a good seal between the needle and syringe, and they are leaking all over therefore the full dose is not being injected."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50789469 ↗MalfunctionSep 15, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50779933 ↗MalfunctionSep 14, 2026Detachment of Device or Device Component
Patient problems: Insufficient Information
MAUDE report 50756165 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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