TERUMO SS-10L2125Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 34806017511358), received between Dec 6, 2024 and Jun 27, 2025 — classified as 3 injuries.

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

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJun 27, 2025Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED PER JANSSEN CANADA (B)(6) THAT THE PATIENT PRESENTED TODAY TO RECEIVE A SIMPONI INFUSION. HE MENTIONED HAVING GENERALIZED PAIN WHEN HE EATS TOO MUCH SUGAR. WHILE PREPARING THE MEDICATION, I WITHDREW 4 ML FROM THE FIFTH VIAL OF MEDICATION. WHEN I CAME TO WITHDRAW 4 ML FROM ANOTHER VIAL WITH THE SAME SYRINGE, I INSERTED THE NEEDLE INTO THE RUBBER STOPPER. AS I WAS ABOUT TO WITHDRAW, THE NEEDLE PARTIALLY DETACHED FROM THE SYRINGE, AND A SMALL AMOUNT OF MEDICATION THAT WAS IN THE SYRINGE AND VIAL CAME OUT AS A SPRAY. THE MEDICATION ENDED UP ON MY FACE (FOREHEAD AND CHIN) AS WELL AS ON MY FOREARMS. I IMMEDIATELY WASHED MY FACE AND HANDS IN THE SINK WITH WARM WATER AND SOAP. THE AIC WAS NOTIFIED, AND A REPORT WAS MADE. WE MANAGED TO ADMINISTER THE PRESCRIBED DOSE TO THE PATIENT WITH THE EXCESS MEDICATION IN THE OTHER VIALS. THE RPN EXPERIENCE SPLASH EXPOSURE REACTION, AND ORAL BENADRYL WAS TAKEN.

  Patient problems: Insufficient Information

  MAUDE report 22352228 ↗
• InjuryDec 6, 2024Crack; Crack

  THE USER FACILITY REPORTED A PATIENT SCHEDULED FOR IUD REPLACEMENT IN 2 WEEKS. DURING THE PREPARATION OF THE LAST VIAL OF REMICADE, THE VIAL EXPLODED, CAUSING THE MEDICATION TO SPILL ONTO THE NURSE'S FACE, NECK, AND CHEST. UPON CLOSER INSPECTION, A CRACK WAS FOUND IN THE SYRINGE, WHICH LED TO THE LEAKAGE. DESPITE THIS, THE PATIENT RECEIVED THE FULL DOSE AS ONLY A PORTION OF THE VIAL WAS NEEDED. THE NURSE EXPERIENCED A SWOLLEN AND NUMB FACE, BURNING LIPS, AND A RASH ON HER FACE AND CHEST. ORAL BENADRYL WAS TAKEN TO ADDRESS THESE SYMPTOMS. ADDITIONAL INFORMATION RECEIVED ON 12 NOV 2024: THE NURSE IS NOW STABLE AND HAS SEEN THEIR FAMILY DOCTOR, WHO PRESCRIBED PREDNISONE AND BLEXTEN. THE ACTUAL PATIENT WAS NOT IMPACTED IN ANY WAY.

  Patient problems: Numbness; Rash; Skin Burning Sensation; Swelling/ Edema

  MAUDE report 20873088 ↗
• InjuryDec 6, 2024Crack; Crack

  THE USER FACILITY REPORTED A PATIENT SCHEDULED FOR IUD REPLACEMENT IN 2 WEEKS. DURING THE PREPARATION OF THE LAST VIAL OF REMICADE, THE VIAL EXPLODED, CAUSING THE MEDICATION TO SPILL ONTO THE NURSE'S FACE, NECK, AND CHEST. UPON CLOSER INSPECTION, A CRACK WAS FOUND IN THE SYRINGE, WHICH LED TO THE LEAKAGE. DESPITE THIS, THE PATIENT RECEIVED THE FULL DOSE AS ONLY A PORTION OF THE VIAL WAS NEEDED. THE NURSE EXPERIENCED A SWOLLEN AND NUMB FACE, BURNING LIPS, AND A RASH ON HER FACE AND CHEST. ORAL BENADRYL WAS TAKEN TO ADDRESS THESE SYMPTOMS. ADDITIONAL INFORMATION RECEIVED ON 12 NOV 2024: THE NURSE IS NOW STABLE AND HAS SEEN THEIR FAMILY DOCTOR, WHO PRESCRIBED PREDNISONE AND BLEXTEN. THE ACTUAL PATIENT WAS NOT IMPACTED IN ANY WAY.

  Patient problems: Numbness; Rash; Skin Burning Sensation; Swelling/ Edema

  MAUDE report 20873058 ↗