SOL-CARE Syringe with Safety Needle 32310SNRecalls & reported problems
Sol-Millennium Medical, Inc. · SOL-CARE 3ml Luer Lock Syringe w/Safety Needle 23Gx1 · Class 2
All models of SOL-CARE Syringe with Safety Needle (8)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00818392019049), received between May 16, 2025 and Dec 1, 2025 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Contamination” (3 reports).
1 FDA recall record name this device's identifier, 1 still open.
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
Recalls naming this device
- May 9, 2024Class IIOpen, Classified
Products in distribution were found by FDA to be to be substantially different from the current cleared 510(k)s with a major change or modification to the device s intended use.
Z-3075-2024 · Root cause: Other · Recall details · FDA record ↗
Most reported problems
Device problems
- Contamination3
- Break1
- Crack1
- Fluid/Blood Leak1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 1, 2025Break; Break
CUSTOMER REPORTED SYRINGE CRACKED AND BECAME UNUSABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23679890 ↗MalfunctionJun 19, 2025Contamination; Contamination
CUSTOMER REPORTED THAT THERE ARE BLACK SPOTS INSIDE THE NEEDLE. AFTER OPENING IT, A HAIR WAS FOUND INSIDE THE EMPTY NEEDLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22289013 ↗MalfunctionMay 22, 2025Contamination; Contamination
CUSTOMER REPORTED THAT THE NEEDLE CAP COULD NOT BE OPENED DUE TO A FOREIGN OBJECT STICKING TOIT, MAKING IT UNUSABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22073542 ↗MalfunctionMay 16, 2025Contamination; Contamination
CUSTOMER REPORTED: THERE IS DEBRIS IN THE SYRINGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22035777 ↗MalfunctionMay 16, 2025Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak
CUSTOMER REPORTED THAT THE LEAKAGE OCCURRED WHILE DRAWING THE MEDICATION AFTER OPENING, AND MULTIPLE CRACKS WERE FOUND UPON INSPECTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22035750 ↗
Other Syringe, piston devices
- BD Luer-Lok 309657Becton, Dickinson And Company · Syringe, piston1,266 reports
- BD Luer-Lok 309653Becton, Dickinson And Company · Syringe, piston948 reports
- BD Luer-Lok 309628Becton, Dickinson And Company · Syringe, piston862 reports
- N/A 302995Becton, Dickinson And Company · Syringe, piston1 recall537 reports
- BD Plastipak Syringe 300865Becton, Dickinson And Company · Syringe, piston515 reports
- N/A 302830Becton, Dickinson And Company · Syringe, piston462 reports
- N/A 302832Becton, Dickinson And Company · Syringe, piston424 reports
- BD Ultra-Fine 328468Becton, Dickinson and Company Inc · Syringe, piston323 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 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page