SOL-CARE™ Safety Needle SN2515Recalls & 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
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00818392010503), received between May 16, 2025 and May 16, 2025 — classified as 2 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
- Fluid/Blood Leak1
Patient problems
- Needle Stick/Puncture1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 16, 2025Fluid/Blood Leak; Fluid/Blood Leak
CUSTOMER REPORTED: AHS MDIP REFERENCE NUMBER (ID): (B)(4). DATE OF INCIDENT (YYYY-MM-DD): (B)(6) 2024 INCIDENT DETAILS: ITEM LEAKS AT THE HUB WHEN INJECTED. LEVEL OF HARM: NO APPARENT HARM - REACHED PATIENT/PERSON, INCONVENIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22035607 ↗MalfunctionMay 16, 2025Defective Component; Defective Component
CUSTOMER REPORTED: PRODUCT CONCERN TICKET NUMBER: (B)(4) , DATE OF INCIDENT: (B)(6) 2023 CONCERN DESCRIPTION: DO NOT WANT THIS PRODUCT ORDERED AGAIN, DUE TO MULTIPLE REPORTS OF NEEDLE STICK INJURIES DUE TO NEEDLE GOING THROUGH SAFETY COVER AND WHEN RECAPPING AFTER DRAWING UP VACCINE BEFORE ADMINISTERING THE VACCINE.
Patient problems: Needle Stick/Puncture
MAUDE report 22035605 ↗
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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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