SOL-CARE Luer Lock Safety Syringe with Exchangeable NeedleRecalls & reported problems across all models
Sol-Millennium Medical, Inc. · 6 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 43
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 0
We found 6 models of SOL-CARE Luer Lock Safety Syringe with Exchangeable Needle by Sol-Millennium Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 43 adverse event reports in the FDA's MAUDE database, received between May 16, 2025 and Mar 24, 2026 — classified as 43 malfunctions.
The most frequently reported specific device problem is “Decoupling” (9 reports).
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
Most reported SOL-CARE Luer Lock Safety Syringe with Exchangeable Needle problems
Device problems
- Decoupling9
- Break7
- Fluid/Blood Leak7
- Contamination5
- Defective Component5
- Retraction Problem4
- Crack3
- Difficult to Fold, Unfold or Collapse3
Patient problems
- No Clinical Signs, Symptoms or Conditions41
- Needle Stick/Puncture2
SOL-CARE Luer Lock Safety Syringe with Exchangeable Needle models
6 models, most reported first. Each model has its own page with its reports, recalls and device details.
- SOL-CARE™ Luer Lock Safety Syringe with Exchangeable Needle 160072IMSYRINGE, ANTISTICK18 reports
- SOL-CARE™ Luer Lock Safety Syringe with Exchangeable Needle 100077IMSYRINGE, ANTISTICK14 reports
- SOL-CARE™ Luer Lock Safety Syringe with Exchangeable Needle 140065IMSYRINGE, ANTISTICK8 reports
- SOL-CARE™ Luer Lock Safety Syringe with Exchangeable Needle 100079IMSYRINGE, ANTISTICK1 report
- SOL-CARE™ Luer Lock Safety Syringe with Exchangeable Needle 100076IMSYRINGE, ANTISTICK1 report
- SOL-CARE™ Luer Lock Safety Syringe with Exchangeable Needle 100078IMSYRINGE, ANTISTICK1 report
Recent SOL-CARE Luer Lock Safety Syringe with Exchangeable Needle adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionMar 24, 2026Break
CUSTOMER REPORTED THE SYRINGE WAS CRACKED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24673966 ↗MalfunctionFeb 17, 2026Break
CUSTOMER REPORTED A CRACK WAS FOUND IN THE SYRINGE BARREL DURING USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24362469 ↗MalfunctionDec 2, 2025Break; Leak/Splash; Break; Leak/Splash
CUSTOMER REPORTED THE SYRINGE RUPTURED. DURING BLOOD COLLECTION WITH AN EMPTY SYRINGE, BLOOD SPLATTERED. UPON INSPECTION, A CRACK WAS FOUND ON THE SYRINGE BARREL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23692123 ↗MalfunctionDec 2, 2025Contamination; Contamination
CUSTOMER REPORTED COTTON FIBERS WERE FOUND INSIDE THE SYRINGE, MAKING IT UNUSABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23692121 ↗MalfunctionDec 1, 2025Leak/Splash; Premature Activation; Leak/Splash; Premature Activation
CUSTOMER REPORTED DURING BLOOD COLLECTION, THE NEEDLE SUDDENLY RETRACTED, CAUSING BLOOD LEAKAGE. CUSTOMER REPORTED THE NEEDLE DETACHED, CAUSING LEAKAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23679891 ↗MalfunctionAug 20, 2025Contamination; Contamination
CUSTOMER REPORTED THAT FOREIGN OBJECT INSIDE THE SYRINGE BARREL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22847519 ↗MalfunctionJul 2, 2025Break; Break
THE REPORTED ISSUE IS BARREL BREAKAGE. THE CUSTOMER NOTICED THE BARREL WAS BROKEN AFTER DRAWING UP THE MEDICATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22382253 ↗MalfunctionJul 2, 2025Break; Break
CUSTOMER REPORTED THAT THE REAR PART OF THE NEEDLE HUB FRACTURED, RENDERING THE PRODUCT UNUSABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22382252 ↗MalfunctionJul 2, 2025Fluid/Blood Leak; Fluid/Blood Leak
CUSTOMER REPORTED THAT THE MEDICATION LEAKED FROM THE INSIDE OF THE SYRINGE TO THE AREA BEHIND THE RUBBER STOPPER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22382251 ↗MalfunctionJul 2, 2025Crack; Crack
CUSTOMER REPORTED THAT THERE IS A CRACK ON THE SYRINGE, CAUSING LEAKAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22382250 ↗MalfunctionJun 20, 2025Break; Break
CUSTOMER REPORTED THAT THE NEEDLE IS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22295037 ↗MalfunctionJun 20, 2025Decoupling; Decoupling
SOL-043 - CUSTOMER REPORTED THE NEEDLE SUDDENLY DETACHED, MAKING IT IMPOSSIBLE TO ADMINISTER THE MEDICATION. SOL-088 - CUSTOMER REPORTED THAT THE NEEDLE FELL OFF. SOL-101, SOL-102, SOL-103 - CUSTOMER REPORTED THAT THE NEEDLE DETACHED. SOL-111 - CUSTOMER REPORTED THAT THE NEEDLE HUB IS LOOSE. SOL-124 - CUSTOMER REPORTED THAT THE NEEDLE HUB IS LOOSE AND UNUSABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22295036 ↗MalfunctionJun 20, 2025Crack; Crack
CUSTOMER REPORTED THAT AFTER USING THE EMPTY SYRINGE FOR BLOOD COLLECTION, IRREGULAR CRACKSWERE FOUND ON THE OUTER BARREL OF THE SYRINGE, INDICATING A NEED TO ENHANCE QUALITY CONTROL. CUSTOMER REPORTED THAT THE SYRINGE BARREL IS CRACKED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22294681 ↗MalfunctionJun 20, 2025Contamination; Defective Component; Contamination; Defective Component
CUSTOMER REPORTED THAT THEY WHEN OPENING THE NEEDLE FOR USE, IT WAS FOUND THAT THERE WAS FOREIGN MATTER (PLASTIC BLOCK) INSIDE THE EMPTY NEEDLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22294680 ↗MalfunctionJun 19, 2025Contamination; Defective Component; Contamination; Defective Component
CUSTOMER REPORTED THAT THEY AFTER UNPACKING THE MEDICINE, I FOUND YELLOW STAINS INSIDE THE SYRINGE BOTTLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22288940 ↗
Other Sol-Millennium Medical, Inc. products
- SOL-M Syringe5 models · 15 reports · 1 recall
- SOL-CARE Syringe with Safety Needle8 models · 7 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
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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