SOL-M™ Hypodermic Needle 112612Recalls & reported problems
Sol-Millennium Medical, Inc. · Sterile hypodermic needles intended to inject fluids into, or withdraw fluids from, parts of the body below the suface of the skin. · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00818392010664), received between May 16, 2025 and May 16, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Dull, Blunt” (1 report).
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
- Dull, Blunt1
Patient problems
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 16, 2025Dull, Blunt; Dull, Blunt
"CUSTOMER REPORTED NEEDLES ARE DULL/BLUNT AND CAUSING DISCOMFORT WHEN USED AS THEY NEED TO BE MUCH SHARPER FOR PENETRATION. " " " "
Patient problems: Pain
MAUDE report 22035657 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.