MEDLINE SSN100217Recalls & reported problems
Medline Industries, Inc. · NEEDLE,HYPODERM,SAFETY,21GX1.5 · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10193489031928), received between Sep 15, 2026 and Sep 17, 2026 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Packaging Problem” (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
- Packaging Problem2
- Break1
- Dull, Blunt1
- Material Twisted/Bent1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Needle Stick/Puncture1
- Pain1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 17, 2026Packaging Problem
It was reported that the caps on safety needle 21G x 1.5 are not properly attached to the needle.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50801969 ↗MalfunctionSep 15, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50779123 ↗MalfunctionSep 15, 2026Dull, Blunt; Material Twisted/Bent
It was reported that ¿It feels as if they're not as sharp as they should be. Normally when I inject someone, the needle goes in like butter, but these needs I can feel them stall at first then I almost feel them going through the muscle.¿
Patient problems: Pain
MAUDE report 50773350 ↗MalfunctionSep 15, 2026Packaging Problem
It was reported that "clear cap not on needle."
Patient problems: Needle Stick/Puncture
MAUDE report 50766546 ↗
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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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