SOL-M™ Hypodermic Needle 112215Recalls & 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 00818392015126), received between May 16, 2025 and May 16, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (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
- Break1
Patient problems
- Device Embedded In Tissue or Plaque1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 16, 2025Break; Break
CUSTOMER REPORTED DURING HYSTEROSCOPY PROCEDURE, SURGICAL RESIDENT WAS INJECTING LOCAL ANESTHETIC INTO THE CERVIX, UPON REMOVAL THE NEEDLE HAD BROKEN OFF THE NEEDLE HUB. WAS LOCATED INTACT IN CERVICAL TISSUE AND REMOVED FROM PATIENT.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 22035540 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.