SOL-M Syringe P180001PPRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00818392018165), received between May 16, 2025 and Jul 3, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Crack” (2 reports).

1 FDA recall record name this device's 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, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. 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 · FDA record ↗

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• 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 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, 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, 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 ↗