SOL-M SyringeRecalls & reported problems across all models
Sol-Millennium Medical, Inc. · 5 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one SOL-M Syringe model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 15
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 1
We found 5 models of SOL-M Syringe by Sol-Millennium Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 15 adverse event reports in the FDA's MAUDE database, received between May 16, 2025 and Mar 5, 2026 — classified as 15 malfunctions.
The most frequently reported specific device problem is “Contamination” (4 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-M Syringe 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, 2024Open, 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-3078-2024 · Root cause: Other · Recall details · FDA record ↗
Most reported SOL-M Syringe problems
Device problems
- Contamination4
- Crack4
- Material Discolored3
- Break2
- Difficult to Fold, Unfold or Collapse2
- Compatibility Problem1
- Component Missing1
- Fluid/Blood Leak1
Patient problems
- No Clinical Signs, Symptoms or Conditions15
SOL-M Syringe models
5 models, most reported first. Each model has its own page with its reports, recalls and device details.
- SOL-M Syringe P180001PPSyringe, piston1 recall5 reports
- SOL-M Syringe P180003Syringe, piston4 reports
- SOL-M Syringe P180060Syringe, piston3 reports
- SOL-M Syringe P180020Syringe, piston2 reports
- SOL-M Syringe P180030Syringe, piston1 report
Recent SOL-M Syringe adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionMar 5, 2026Break; Crack
CUSTOMER REPORTED TWO OCCURRENCES WHERE THE SYRINGE TIP OF THE 60 ML LUER-LOCK SYRINGE FRACTURED WHILE UNSCREWING THE LUER-LOCK CONNECTION FROM THE EASYPUMP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24518040 ↗MalfunctionSep 18, 2025Break; Break
CUSTOMER REPORTED TWO INCIDENTS THAT THE HUB OF THE SYRINGE BROKE OFF WHILE PREPARING A STENT, SO WE HAD TO OPEN AN ADDITIONAL STENT. NO SAMPLES AVAILABLE. UPON CONNECTING 20ML L/L SYRINGE TO A CORONARY STENT SHEATH, THE LUER LOCK SNAPPED AND REMAINED INSIDE THE STENT SHEATH ENTRY PORT RENDERING THE STENT UNUSABLE. NO SAMPLES AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23082772 ↗MalfunctionJul 23, 2025Crack; Crack
CUSTOMER REPORTED THAT THE BARREL CRACKED DOWN LENGTH OF BARREL SO LEAKS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22574108 ↗MalfunctionJul 3, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse
CUSTOMER REPORTED THAT THEY GOT A WHOLE BOX OF SOL-M 1ML LUER LOCK SYRINGES WITHOUT NEEDLES FROM THE PHARMACY AS I MUST GIVE MYSELF AN INJECTION EVERY WEEK. MY USUAL PHARMACY CARRIES A DIFFERENT BRAND, BUT I COULDN'T GET THEM IN BULK FROM THERE, SO THIS WAS MY FIRST TIME USING SOL-M SYRINGES. (PREVIOUSLY I HAD USED BD SYRINGES). I'M INJECTING TESTOSTERONE ENANTHATE (IN SESAME OIL) AND MY ONLY GUESS IS THAT IT'S TOO THICK TO INJECT SMOOTHLY. I MUST PRESS DOWN REALLY HARD TO GET THE PLUNGER TO MOVE AT ALL AND WHEN IT DOES IT'S JERKY. I'VE TRIED WARMING THE FILLED SYRINGE WITH MY HANDS AND A LITTLE WITH MY SPACE HEATER, BUT IT HASN'T HELPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22392117 ↗MalfunctionJun 20, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse
AS A REPLACEMENT FOR THE INITIAL PRODUCT WHICH IS OUT OF STOCK, WE ARE RECEIVING THE COMPANY SOL-MILLENIUM MEDICAL. THE PISTON OF THESE SYRINGES <SLIDE> AND IT IS VERY DIFFICULT TO ADJUST A VOLUME. THE PISTON MOVES AS SOON AS WE NO LONGER HOLD IT IN PLACE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22295927 ↗MalfunctionJun 11, 2025Contamination; Contamination
CUSTOMER REPORTED THAT THE BROWN RESIDUE ON THE INSIDE OF THE BARREL OF THIS SYRINGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22182344 ↗MalfunctionMay 16, 2025Material Discolored; Compatibility Problem; Material Discolored; Compatibility Problem
CUSTOMER REPORTED THAT THE MEDICATION CHANGES COLOR WHEN IN SYRINGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22035726 ↗MalfunctionMay 16, 2025Material Discolored; Material Discolored
CUSTOMER REPORTED THAT THE ISSUE IS THAT AFTER MEDICATION IS BEING DRAWN INTO THE SYRINGES, THE MEDICATION IS TURNING COLORS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22035704 ↗MalfunctionMay 16, 2025Fluid/Blood Leak; Fluid/Blood Leak
CUSTOMER REPORTED: NEEDLE LEAKED ALL THE BOTOX OUT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22035688 ↗MalfunctionMay 16, 2025Crack; Crack
"CUSTOMER REPORTED PT CAME FOR MODERNA COVID INJECTION TONIGHT. AS I WAS INJECTING THE VACCINE INTO THE PT., THE NEEDLE WAS IN THE PTS DELTOID MUSCLE CORRECTLY, WHEN I STARTED TO PRESS ON THE SYRINGE. THEN THE HUB OF THE SYRINGE SPRAYED OUTWARD THE VACCINE, SPRAYING THE PTS WIFE AND MYSELF. THE PT DID NOT GET THE VACCINE. THE NEEDLE POINT WAS REMOVED FROM THE PT., AND COTTON BALL APPLIED TO THE SITE. A SECOND SHOT WAS GIVEN TO THE PT., AS HE ACCEPTED THE SYRINGE WAS DEFECTIVE. PT DID NOT SUFFER ANY PAIN OR DISCOMFORT, ONLY THE FACT OF HAVING A SECOND COVID VACCINATION. THIS WAS FINE ACCORDING TO THE PT. AND CHARTED AS SUCH. ON INSPECTION AFTERWARDS, THE HUB OF THE 1 CC SINGLE USE SYRINGE HAD A CRACK IN IT AND WAS DEEMED DEFECTIVE. "
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22035645 ↗MalfunctionMay 16, 2025Contamination; Contamination
CUSTOMER REPORTED: WE FOUND THAT THERE IS A HAIR INSIDE THE PISTON OF THE SYRINGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22035527 ↗MalfunctionMay 16, 2025Crack; Component Missing; Crack; Component Missing
"CUSTOMER REPORTED: WE RECEIVED A COMPLAINT FROM RIVM FOR ITEM P180001PP WITH BATCH 04105025. IT HAD SEVERAL DEFECTS: SYRINGE WITHOUT GRADUATION MARKS: 1 PIECE. SYRINGE WITHOUT PLUNGER: 1 PIECE. CLOSED PACKAGING WITHOUT SYRINGE: 1 PIECE. SYRINGE EXPANDED AND WITH FISSURES; FRACTURE CRACKS: 3 PIECES."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22035476 ↗MalfunctionMay 16, 2025Contamination; Contamination
CUSTOMER REPORTED: FOR YOU INFORMATION AND TO BE DOCUMENTED, LAST BATCH THAT DELIVERED TO (B)(6) HOSPITAL THROUGH ARABIAN HEALTH CARE HAS QUALITY ISSUE ( 2 SYRINGES HAS A PLASTIC PARTICLE INSIDE THE SYRINGE PLUNGER) BLOW MORE DETAILS REGARDING THE ITEMS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22035445 ↗MalfunctionMay 16, 2025Material Discolored; Material Discolored
"CUSTOMER REPORTED THAT THE MEDICATION CHANGES COLOR WHEN IN SYRINGE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22035437 ↗MalfunctionMay 16, 2025Contamination; Contamination
"CUSTOMER REPORTED: "IN OUR NICU THEY WERE OPENING A 30CC LUER LOCK SYRINGE AND FOUND A STRAND OF HAIR INSIDE THE PACKAGING. THIS THEN TRIGGERED A STERILE INCIDENT REPORT WITH OUR QUALITY DEPARTMENT."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22035415 ↗
Other Sol-Millennium Medical, Inc. products
- 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
- 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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