SOL-CARE Safety Needle 25G*1 SN2510Recalls & reported problems
Sol-Millennium Medical, Inc. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00810018090333), received between Jun 18, 2025 and Aug 13, 2025 — classified as 3 malfunctions.
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
- Dull, Blunt1
- Fluid/Blood Leak1
Patient problems
- Needle Stick/Puncture1
- No Clinical Signs, Symptoms or Conditions1
- Pain1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 13, 2025Fluid/Blood Leak; Fluid/Blood Leak
CUSTOMER REPORTED THAT WRITER SECURELY ATTACHED SOL-CARE NEEDLE TIP TO SYRINGE (309657) AND PRIMED TO CORRECT DOSE. CLIENT PRESENT AND WITNESSED AND VERIFIED DOSE. WHILE SELF-INJECTING MEDICATION IM, MEDICATION BEGAN LEAKING OUT OF NEEDLE TIP, POOLING IN LUER LOCK. SMALL AMOUNT OF MEDICATION (ESTIMATED 5 MG) WASTED. NEW NEEDLE TIP APPLIED, AND CLIENT SELF ADMINISTERED REMAINDER OF DOSE WITH NO FURTHER ISSUES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22790980 ↗MalfunctionJun 18, 2025Dull, Blunt; Dull, Blunt
CUSTOMER REPORTED THAT THEY DIFFICULT TO INJECT NEEDLE. FEELS LIKE IT IS NOT LUBRICATED AND THERE IS A LOT OF FRICTION. INJECTIONS ARE NOT SMOOTH AND CAUSING INCREASED PAIN TO CLIENTS. MOST CLIENTS ARE BABIES AND CHILDREN. INCREASED CRYING NOTED IN CLINICS AFTER CHANGING NEEDLES.
Patient problems: Pain
MAUDE report 22269587 ↗MalfunctionJun 18, 2025Defective Component; Defective Component
CUSTOMER REPORTED THAT THEY TRIED TO ENGAGE THE SAFETY LOCK AFTER DRAWING THE VACCINE, THE ORANGE SAFETY LOCK FELL OFF THE SYRINGE AND ALMOST STAB MY THUMB WITH THE NEEDLE.
Patient problems: Needle Stick/Puncture
MAUDE report 22269570 ↗
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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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