SOL-CARE Syringe with Safety NeedleRecalls & reported problems across all models
Sol-Millennium Medical, Inc. · 8 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names at least one SOL-CARE Syringe with Safety Needle model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 1
We found 8 models of SOL-CARE Syringe with Safety Needle by Sol-Millennium Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 7 adverse event reports in the FDA's MAUDE database, received between May 16, 2025 and Dec 1, 2025 — classified as 7 malfunctions.
The most frequently reported specific device problem is “Contamination” (3 reports).
1 FDA recall record name at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
SOL-CARE Syringe with Safety Needle recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- 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 · names 8 of these models · Recall details · FDA record ↗
Most reported SOL-CARE Syringe with Safety Needle problems
Device problems
- Contamination3
- Break2
- Fluid/Blood Leak2
- Crack1
Patient problems
- No Clinical Signs, Symptoms or Conditions7
SOL-CARE Syringe with Safety Needle models
8 models, most reported first. Each model has its own page with its reports, recalls and device details.
- SOL-CARE Syringe with Safety Needle 32310SNSyringe, piston1 recall5 reports
- SOL-CARE Syringe with Safety Needle 32510SNSyringe, piston1 recall2 reports
- SOL-CARE Syringe with Safety Needle 12558SNSyringe, piston1 recall0 reports
- SOL-CARE Syringe with Safety Needle 12705SNSyringe, piston1 recall0 reports
- SOL-CARE Syringe with Safety Needle 13005SNSyringe, piston1 recall0 reports
- SOL-CARE Syringe with Safety Needle 32110SNSyringe, piston1 recall0 reports
- SOL-CARE Syringe with Safety Needle 32215SNSyringe, piston1 recall0 reports
- SOL-CARE Syringe with Safety Needle 32558SNSyringe, piston1 recall0 reports
Recent SOL-CARE Syringe with Safety Needle adverse event reports
The 7 most recent reports across all models, 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 ↗MalfunctionNov 7, 2025Fluid/Blood Leak; Fluid/Blood Leak
CUSTOMER REPORTED THAT WHILE DRAWING UP VACCINE USING A SOL-CARE SYRINGE WITH SAFETY NEEDLE, THE VACCINE STARTED SPRAYING OUT OF THE NEEDLE AT THE HUB, SO WAS UNABLE TO DRAW UP FULL DOSE OF VACCINE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23496482 ↗MalfunctionAug 28, 2025Break; Break
CUSTOMER REPORTED THAT THEY PUT ONE OF THE NEEDLES ON A SYRINGE (THE SYRINGE IT WAS PACKAGED WITH) AND HEARD A CLICK. BECAUSE THEY ARE NEW TO ME, I HAD A CLOSE LOOK TO SEE IF IT WAS A LOCKING MECHANISM ENGAGING OR SOMETHING AND NOTICED THAT THE HUB WAS CRACKED FROM THE BOTTOM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22910724 ↗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 Sol-Millennium Medical, Inc. products
- SOL-M Syringe5 models · 15 reports · 1 recall
- SOL-M Luer Lock Syringe with Exchangeable Needle22 models · 6 reports · 1 recall
- SOL-M Luer Lock Syringe w/Exch Needle2 models · 0 reports · 1 recall
- SOL-M Luer Lock Syringe w/Exch Needle Tray2 models · 0 reports · 1 recall
- SOL-M Luer Lock Syringe with Blunt Fill Needle3 models · 0 reports · 1 recall
- SOL-CARE Safety Needle11 models · 48 reports
- SOL-CARE Luer Lock Safety Syringe with Exchangeable Needle6 models · 43 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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