SOL-CARE™ Safety Needle SN3012Recalls & reported problems
Sol-Millennium Medical, Inc. · The SOL-CARE™ Safety Needle is used for general purpose injection and aspiration of fluids from vials, ampules, and parts of the body below the surface of the skin. · Class 2
All models of SOL-CARE Safety Needle (11)
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 00818392010404), received between May 16, 2025 and May 16, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Defective Component” (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
- Defective Component1
Patient problems
- Needle Stick/Puncture1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 16, 2025Defective Component; Defective Component
"THE SOL-CARE SAFETY NEEDLE FOLDS UP AFTER THE NEEDLE GUARD IS FOLDED OVER THE NEEDLE, SO THAT THE NEEDLE POINTS UP AT A 90 DEGREE ANGLE AND IS NOT COVERED BY THE GUARD. HIGH RISK OF STABBING INJURY! THIS HAS HAPPENED SEVERAL TIMES AND IT CANNOT THEREFORE BE RULED OUT THAT IT IS ONLY FROM PACKAGING WITH THE SPECIFIED LOT NUMBER. THE CONTACT PERSON DOES NOT KNOW HOW THE SAFETY ARM HAS BEEN ACTIVATED REGARDING THE CANNULA IN THE PHOTO BUT USUALLY ACTIVATES IT THROUGH A HARD SURFACE.
Patient problems: Needle Stick/Puncture
MAUDE report 22035564 ↗
Other Needle, hypodermic, single lumen devices
- BD Nano 2nd Gen 320550Becton Dickinson Pen Limited · Needle, hypodermic, single lumen2,044 reports
- BD SafetyGlide 305916Becton, Dickinson And Company · Needle, hypodermic, single lumen1,767 reports
- BD Nano Ultra-Fine 320122Becton Dickinson Pen Limited · Needle, hypodermic, single lumen601 reports
- N/A 305106Becton, Dickinson And Company · Needle, hypodermic, single lumen1 recall467 reports
- N/A 305110Becton, Dickinson And Company · Needle, hypodermic, single lumen418 reports
- BD Safe-Clip 328235Becton, Dickinson and Company Inc · Needle, hypodermic, single lumen268 reports
- BD Ultra-Fine 320109Becton Dickinson Pen Limited · Needle, hypodermic, single lumen229 reports
- BD AutoShield Duo 329515Becton, Dickinson And Company · Needle, hypodermic, single lumen208 reports
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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