SOL-CARE™ Safety Needle SN2558Recalls & 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
- 10
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00818392010480), received between May 16, 2025 and May 13, 2026 — classified as 10 malfunctions.
The most frequently reported specific device problem is “Defective Component” (5 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, 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 Component5
- Fluid/Blood Leak3
- Activation Problem1
- Decoupling1
- Material Twisted/Bent1
Patient problems
- Needle Stick/Puncture5
- No Clinical Signs, Symptoms or Conditions5
Recent adverse event reports
The 10 most recent of 10 reports, 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 ↗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 ↗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, 2025Material Twisted/Bent; Material Twisted/Bent
WHILE RECAPPING SOL CARE NEEDLE 25G 5/8""AFTER PUNCTURING MMR-VAR VACCINE VIALS TO CHANGE OUT NEEDLE, THE NEEDLE BENT AND PUNCTURE SKIN VIA THE PLASTIC CAP. NEEDLE WAS NOT USED ON CLIENT PRIOR TO INCIDENT.
Patient problems: Needle Stick/Puncture
MAUDE report 22035660 ↗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: THE SUBSTITUTE IS VERY UNSAFE! THE NEEDLE IS COMPLETELY EXPOSED PRE AND POST INJECTION. THE COVER TO GO UP OVER NEEDLE GETS IN THE WAY OF INJECTING THE SYRINGE AND HAS A HIGH RISK FOR NEEDLE STICKS. IT DOES REQUIRE TWO HANDS TO COVER THE NEEDLE WITH THE ATTACHED COVER THEREFORE INCREASING THE RISK OF A NEEDLE STICK. THIS IS AN ONGOING ISSUE AS THE SUB IS LASTING A LONG TIME. WE USE SEVERAL OF THESE NEEDLES EVERY DAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22035634 ↗MalfunctionMay 16, 2025Fluid/Blood Leak; Fluid/Blood Leak
"CUSTOMER REPORTED WRITER WAS VACCINATING CHILD WITH MMR-VAR VACCINE WITH A NEW SUPPLY OF 5/8TH NEEDLE SOL-CARE SN (B)(6). WHEN WRITER WENT TO VACCINATE CHILD, THE CUSTOMER REPORTED LIQUID SOLUTION HAD LEAKED BETWEEN THE SYRINGE AND THE NEEDLE AND SPLASHED UP INTO FATHER'S FACE WHO WAS HOLDING THE CHILD AND SPLASHED INTO HIS EYE. FATHER REPORTED HE WAS OKAY, HOWEVER CHILD RECEIVED AND INEFFECTIVE DOSE. CHILD THEN REQUIRED TO BE REIMMUNIZED WITH AN EFFECTIVE DOSE IMMEDIATELY AFTER. AFTER THE EVENT, WRITER THEN TOOK A NEW 5/8TH HYPODERMIC NEEDLE (SOL-CARE) AND TIGHTENED IT ONTO A NEW 3 ML SYRINGE; TO FURTHER INVESTIGATE/PRACTICE. I TIGHTENED IT WITH THE SAME AMOUNT OF FORCE I TYPICALLY USED WITH WITHOUT ISSUE, AND A 2ND 5/8TH SOL-CARE NEEDLE CRACKED AGAIN, CLOSE TO THE BASE OF THE SAFETY SHIELD. ANOTHER COLLEAGUE THEN TOOK ANOTHER OF THE NEW 5/8TH SOL-CARE NEEDLES AND WAS UNABLE TO TIGHTEN IT TO ANOTHER 3 ML SYRINGE, AS IT SEEMED THAT THE THREADS WERE STRIPPED ON HER 5/8TH SAFETY SOL-CARE NEEDLE AND WOULD NOT TIGHTEN ON HER SYRINGE AT ALL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22035613 ↗MalfunctionMay 16, 2025Defective Component; Defective Component
"CUSTOMER REPORTED EMS ACP RECEIVED A NEEDLE STICK INJURY POST IM INJECTION AS THE IM NEEDLE DID NOT SAFETY LOCK AFTER BEING PUSHED UP.
Patient problems: Needle Stick/Puncture
MAUDE report 22035563 ↗MalfunctionMay 16, 2025Fluid/Blood Leak; Fluid/Blood Leak
CUSTOMER REPORTED: AHS MDIP REFERENCE NUMBER (ID): (B)(4) DATE OF INCIDENT (YYYY-MM-DD): ON (B)(6) 2024 INJECTING SUBCUTANEOUS CYTOTOXIC MEDICATION USING SOL-CARE 25G X 5/8 INCHES INJECTION NEEDLE WHEN APPLYING NEEDLE TO SYRINGE TIGHTENED, HEARD SLIGHT "CLICK" INDICATING NEEDLE WAS AS TIGHT AS CAN GO? NO DEFECTS ON INSPECTION, WHEN ADMINISTERING MEDICATION MED LEAKED FROM WHERE THE SAFETY ATTACHED TO THE NEEDLE ONTO PATIENT SKIN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22035434 ↗
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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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