SOL-M Hypodermic Needle 21G*50mm 112120Recalls & reported problems
Sol-Millennium Medical, Inc. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- 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 00818392015751), received between Sep 12, 2025 and Sep 12, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Patient Device Interaction Problem” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Patient Device Interaction Problem1
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.
MalfunctionSep 12, 2025Patient Device Interaction Problem; Patient Device Interaction Problem
CUSTOMER REPORTED THAT SINCE THE END OF 2024, ALL NUCLEAR MEDICINE PHYSICIANS IN THE DEPARTMENT HAVE NOTICED THE APPEARANCE OF PULMONARY SPOTS ON BONE SCINTIGRAPHY SCANS IN CERTAIN PATIENTS. INITIALLY, 9 CASES WERE REPORTED TO CURIUM, THE MANUFACTURER OF THE RADIOPHARMACEUTICAL USED FOR THESE EXAMINATIONS. A QUALITY DEFECT IN THE BATCHES OF THE RADIOPHARMACEUTICAL CONCERNED WAS RULED OUT BY THE MANUFACTURER, WHO INSTEAD SUGGESTED A CAUSE RELATED TO INJECTION (BLOOD CLOTS). THIS HYPOTHESIS SEEMS UNLIKELY, AS WE NOW HAVE 60 PATIENTS AFFECTED BY THESE PULMONARY SPOTS. BLOOD CLOTS ARE DESCRIBED IN THE SCIENTIFIC LITERATURE BUT REMAIN RELATIVELY RARE (LESS THAN 1/1000). WE HAVE LOOKED FOR OTHER POSSIBLE CAUSES, AND IT TURNS OUT THAT SINCE EARLY DECEMBER 2024, WE HAVE CHANGED THE REFERENCE OF HYPODERMIC NEEDLES USED BOTH FOR THE PREPARATION OF THE RADIOPHARMACEUTICAL AND FOR DRAWING THE DOSES TO BE ADMINISTERED. WE THEREFORE WONDER WHETHER THERE COULD BE AN INTERACTION BETWEEN THE METAL OF THE NEEDLES AND THE RADIOPHARMACEUTICAL DURING ITS PREPARATION.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 23035216 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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