SOL-CARE Safety NeedleRecalls & reported problems across all models
Sol-Millennium Medical, Inc. · 11 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 48
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 0
We found 11 models of SOL-CARE Safety Needle by Sol-Millennium Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 48 adverse event reports in the FDA's MAUDE database, received between May 16, 2025 and May 13, 2026 — classified as 48 malfunctions.
The most frequently reported specific device problem is “Defective Component” (17 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 Safety Needle problems
Device problems
- Defective Component17
- Fluid/Blood Leak16
- Decoupling5
- Dull, Blunt3
- Material Twisted/Bent3
- Break2
- Activation Problem1
- Complete Blockage1
Patient problems
- No Clinical Signs, Symptoms or Conditions25
- Needle Stick/Puncture17
- Intraoperative Cardiac Valve Injury3
- Pain2
- Device Embedded In Tissue or Plaque1
- Skin Tears1
SOL-CARE Safety Needle models
11 models, most reported first. Each model has its own page with its reports, recalls and device details.
- SOL-CARE™ Safety Needle SN2510Needle, hypodermic, single lumen28 reports
- SOL-CARE™ Safety Needle SN2558Needle, hypodermic, single lumen10 reports
- SOL-CARE™ Safety Needle SN2515Needle, hypodermic, single lumen2 reports
- SOL-CARE™ Safety Needle SN3012Needle, hypodermic, single lumen1 report
- SOL-CARE™ Safety Needle SN2310Needle, hypodermic, single lumen1 report
- SOL-CARE™ Safety Needle SN2315Needle, hypodermic, single lumen1 report
- SOL-CARE™ Safety Needle SN2215Needle, hypodermic, single lumen1 report
- SOL-CARE™ Safety Needle SN2115Needle, hypodermic, single lumen1 report
- SOL-CARE™ Safety Needle SN2010Needle, hypodermic, single lumen1 report
- SOL-CARE™ Safety Needle SN1815Needle, hypodermic, single lumen1 report
- SOL-CARE Safety Needle PSN2515Needle, hypodermic, single lumen1 report
Recent SOL-CARE Safety Needle adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionMay 13, 2026Activation Problem
CUSTOMER REPORTED THAT THE SECURITY DID NOT CLOSE CORRECTLY AND THE NEEDLE HURT THE USER ON THE HAND.
Patient problems: Needle Stick/Puncture
MAUDE report 25158751 ↗MalfunctionAug 22, 2025Fluid/Blood Leak; Fluid/Blood Leak
CUSTOMER REPORTED THAT WHEN ADMINISTERING THE MEN-C-C VACCINE TO A 2-MONTH-OLD INFANT, THE VACCINE CONTENTS LEAKED OUT FROM BASE OF THE 1-INCH NEEDLE (WHERE CONNECTED TO THE SYRINGE/ VACCINE) UPON DEPRESSING THE PLUNGER/ ADMINISTERING.NO VACCINE WAS ADMINISTERED INTO THE MUSCLE
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22870263 ↗MalfunctionJul 29, 2025Defective Component; Defective Component
CUSTOMER REPORTED THAT THE SAFETY CAP DID NOT SECURE PROPERLY WHEN CLICKED AND RESULTED IN NURSE NEEDLESTICK INJURY. ORANGE SAFETY CAP IS VERY FLIMSY, AND PLASTIC DOES NOT LATCH SECURELY OR RELIABLY. DESIGN OF ORANGE SAFETY CAP IS THIN AND SMOOTH AND NOT SAFE TO CLOSE.
Patient problems: Needle Stick/Puncture
MAUDE report 22641358 ↗MalfunctionJul 23, 2025Fluid/Blood Leak; Fluid/Blood Leak
CUSTOMER REPORTED THAT THE VACCINE SPRAYED OUT FROM BETWEEN THE NEEDLE AND SYRINGE AND DID NOT GET INJECTED INTO PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22574110 ↗MalfunctionJun 30, 2025Decoupling; Defective Component; Decoupling; Defective Component
CUSTOMER REPORTED THAT THEY AFTER THE NURSE FINISHED DRAWING UP VACCINE AND RECAPPED THE NEEDLE, SHE FELT A POKE AND REALIZED THE NEEDLE HAD POKED THROUGH THE PLASTIC CAP. THERE ARE TWO ISSUES WITH THESE NEEDLES: 1. THE NEEDLE IS FLIMSY AND FLEXIBLE AND MOVES SIDE TO SIDE AND, 2. THE PLASTIC CAP IS MADE WITH INFERIOR PLASTIC THAT IS SOFT.
Patient problems: Needle Stick/Puncture
MAUDE report 22356358 ↗MalfunctionJun 30, 2025Fluid/Blood Leak; Fluid/Blood Leak
CUSTOMER REPORTED THAT WHEN ATTACHING 5/8" NEEDLE TO SYRINGE, SAFETY MECHANISM PULLED OFF. WRITER ATTEMPTED TO CHANGE NEEDLE BUT WAS UNABLE TO TWIST FROM LUER LOCK SYSTEM. WRITER INSPECTED NEEDLE AND NO CONCERNS NOTED (OTHER THAN SAFETY MECHANISM OFF), SO INSTEAD OF WASTING VACCINE, WRITER CHOSE TO VACCINATE WITHOUT SAFETY MECHANISM. UPON INJECTION, VACCINE SQUIRTED OUT OF SIDES OF LUER LOCK AND NEEDLE HUB. MORE THAN HALF OF THE DOSE WAS NOT ADMINISTERED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22356332 ↗MalfunctionJun 24, 2025Defective Component; Defective Component
CUSTOMER REPORTED HYPODERMIC NEEDLE WAS USED FOR AN IM INJECTION AND POST INJECTION, PRACTITIONER FOLDED THE SECURE ORANGE COVER UP, PUSHING IT TO SECURE IT, BUT IT DID NOT LOCK WHICH RESULTED IN THE PRACTITIONER ENDING UP WITH A NEEDLE STICK INJURY FORM A DIRTY NEEDLE POST INJECTION.
Patient problems: Needle Stick/Puncture
MAUDE report 22318545 ↗MalfunctionJun 23, 2025Defective Component; Defective Component
CUSTOMER REPORTED THAT THE NEEDLES ARE DIFFICULT TO USE, AND UNCAPPING/RECAPPING IS LEADING TO NEEDLE STICK INJURIES AMONG STAFF.
Patient problems: Needle Stick/Puncture
MAUDE report 22306645 ↗MalfunctionJun 23, 2025Defective Component; Defective Component
CUSTOMER REPORTED THAT THE MULTIPLE ISSUES WITH SAFETY. WE ORDER THE OTHER ONES, AND THEY KEEP SENDING THESE. THEY ARE NOT SAFE. A NEEDLESTICK INJURY OCCURRED TODAY BUT MANY OTHER TIMES THESE HAVE BEEN A SAFETY RISK.
Patient problems: Needle Stick/Puncture
MAUDE report 22305999 ↗MalfunctionJun 17, 2025Decoupling; Decoupling
CUSTOMER REPORTED THAT THE SYRINGE DOES NOT ATTACH TO NEEDLE SECURELY. THE SYRINGE POPS OFF EASILY CAUSING INJURIES. THE NEEDLE BENDS EASILY WHICH CAN CAUSE INJURY TO THE PATIENT AND IMMUNIZER. NO ADVERSE EVENT REPORTED.
Patient problems: Needle Stick/Puncture
MAUDE report 22226585 ↗MalfunctionMay 16, 2025Break; Break
CUSTOMER REPORTED: THE ISSUE THEY HAVE HAD IS THAT THE NEEDLE REFERENCE (B)(6) BROKE WHILE BEING USED INSIDE THE PATIENT. WE ARE CHECKING WITH THE CUSTOMER IF THEY HAVE RAISED AN MHRA COMPLAINT. OBVIOUSLY THIS IS A CONCERNING ISSUE, AND FOR THE MOMENT, THE CUSTOMER HAS QUARANTINED THE PACKS WITH THIS REFERENCE, BUT OBVIOUSLY WE NEED TO KNOW THE LOT NUMBER OF THE NEEDLE AS THERE MAY BE OTHER LOTS OF PACKS AFFECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22035824 ↗MalfunctionMay 16, 2025Material Twisted/Bent; Material Twisted/Bent
CUSTOMER REPORTED: AHS MDIP REFERENCE NUMBER (ID): (B)(4). DATE OF INCIDENT (YYYY-MM-DD): 2024-07-05 INCIDENT DETAILS: CLIENT SEEN IN WELL CHILD CLINIC. I ATTACHED SYRINGE (REF SN2510, LOT 07108039) TO TDAP-IPV. NO PROBLEMS NOTED WITH NEEDLE AT THAT TIME. I IMMUNIZED THE CLIENT IN THE LEFT ARM. NOTHING ABNORMAL HAPPENED DURING IMMUNIZATION. I DID NOT HIT THE BONE. THERE WAS NO PROBLEMS INJECTING. NO LEAKING AROUND NEEDLE. BUT WHEN I PULLED OUT THE NEEDLE FROM CLIENT'S ARM, IT WAS BENT WHERE THE METAL NEEDLE ATTACHES TO THE PLASTIC HUB. IMPACT OF INCIDENT: NO HARM TO CLIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22035706 ↗MalfunctionMay 16, 2025Defective Component; Material Twisted/Bent; Defective Component; Material Twisted/Bent
CUSTOMER REPORTED: NEEDLES HAVE SEVERAL ISSUES. NEEDLES ARE FLIMSY AND BEND EASILY. SAFETY CAP DOESNT SNAP IN PLACE CLEANLY AND SOMETIMES DOESNT OFFER PROTECTION AND NEEDLE HUB DOESNT HOLD TO SYRINGE WELL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22035701 ↗MalfunctionMay 16, 2025Defective Component; Defective Component
CUSTOMER REPORTED: AHS MDIP REFERENCE NUMBER (ID): (B)(4), DATE OF INCIDENT (YYYY-MM-DD): (B)(6) 2024, INCIDENT DETAILS: NEEDLE/SYRINGE FAILURE. NEEDLE (SOL-CARE 25GX5/8", LOT#02011050) TWISTED IN SYRINGE (BD 3ML LUER-LOK TIP, LOT#0217372) TO INJECT MMR VACCINE. CONNECTION FAILED AND ENTIRE CONTENTS OF SYRINGE SPRAYED OUT AT CONNECTION SITE. IMPACT OF INCIDENT: NEW DOSE OF MMR WAS ADMINISTERED IN A DIFFERENT SITE. CLIENT SUSTAINED AN ADDITION NEEDLE POKE AS A RESULT OF THE FAILURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22035681 ↗MalfunctionMay 16, 2025Fluid/Blood Leak; Fluid/Blood Leak
ATTEMPTING TO DISPEL AIR FROM SYRINGE. VACCINE SPRAYED FROM CONNECTION OF NEEDLE TO VACCINE SYRINGE. 4 DOSES OF HEXA, 2 DOSES OF BOOSTRIX POLIO AND 1 DOSE OF MEN C WASTED. SUSPECT BLOCKED NEEDLES. IMPACT OF INCIDENT: NO PATIENT AFFECTED LEVEL OF HARM: NO EFFECT - DID NOT REACH PATIENT - DETECTED BEFORE USE OR DOES NOT TOUCH PERSON DURING USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22035670 ↗
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 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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