TERUMO NN2516RRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 34806017511969), received between Aug 25, 2023 and Sep 16, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (3 reports).

9 other recalls cover devices cleared under the same FDA submission (K121607); they may or may not involve this specific model.

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 16, 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.

• MalfunctionSep 16, 2025Break; Break

  TERUMO MEDICAL RECEIVED A REPORT STATING THAT DURING USE OF A NEEDLE ON A FELINE PATIENT, THE NEEDLE DISCONNECTED FROM THE SYRINGE AND REMAINED INSIDE THE PATIENT. THE INCIDENT REQUIRED APPROXIMATELY ONE ADDITIONAL HOUR OF TREATMENT, INCLUDING X-RAY IMAGING AND MANUAL MANIPULATION TO PUSH THE NEEDLE BACK OUT THROUGH THE SKIN. NO SURGERY WAS REQUIRED. ONE OPENED BOX OF PRODUCT WAS QUARANTINED AT THE CLINIC LOCATION. THE PROCEDURE WAS COMPLETED, AND THE PATIENT WAS NOT HARMED. NO BLOOD LOSS WAS REPORTED. THE EVENT OCCURRED INTRA-OPERATIVE. ADDITIONAL INFORMATION RECEIVED ON 28 AUG 2025: THE END USER CONFIRMED THAT THE PATIENT REMAINED STABLE AND EXPERIENCED NO INJURY. THE NEEDLE WAS SUCCESSFULLY BACKED OUT WITHOUT CAUSING DAMAGE.

  Patient problems: Foreign Body In Patient

  MAUDE report 23061891 ↗
• MalfunctionMar 25, 2025Break; Break

  THE USER FACILITY REPORTED THAT A 25G NEEDLE BROKE OFF COMPLETELY FROM THE HUB AND WAS STUCK UNDER THE PATIENT'S SKIN. THE NEEDLE HAD TO BE QUICKLY SHAVED AND CIRCLED, THE PATIENT ANESTHETIZED, AND THE NEEDLE RETRIEVED, WHICH HAD ALREADY MIGRATED TO A DIFFERENT LOCATION IN THE PATIENT. IT WAS VERY FORTUNATE TO HAVE LOCATED IT. THERE WAS NO BLOOD LOSS REPORTED. ADDITIONAL INFORMATION WAS RECEIVED ON 27 FEB 2025: THE NEEDLE WAS USED IN THE EPAXIAL MUSCLE TO ADMINISTER A PREMEDICATION. IT WAS GIVEN BY A STUDENT. NO IRREGULARITY WAS OBSERVED ON THE NEEDLE PRIOR TO BREAKAGE. THE PATIENT'S CONDITION IS FINE, WITH NO ISSUES NOTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 21694447 ↗
• MalfunctionAug 25, 2023Break; Break

  THE USER FACILITY REPORTED THAT ONE OF THEIR VETERINARIANS WAS ADMINISTERING A VACCINE SUBQ FOR A VETERINARY PATIENT AND NOT IM. THE NEEDLE TIP WENT IN WITH NO ISSUES AND WAS NOT BENT. WHEN THE VETERINARIAN ATTEMPTED TO PUSH THE VACCINE THROUGH THE NEEDLE IT WOULD NOT PUSH. THEREFORE, THE SYRINGE WAS REMOVED HOWEVER, THE ENTIRE NEEDLE WAS MISSING, BROKEN OFF AT THE EXIT FROM THE HUB. IT TOOK CLOSE TO TWO (2) HOURS TO REMOVE THE NEEDLE FROM THE PATIENT BY TAKING SERIAL RADIOGRAPHS TO LOCATE PRIOR TO INCISING THE SCRUFF. THE PATIENT DID NOT MOVE AT ALL DURING THE ATTEMPTED ADMINISTRATION OF THE VACCINE AND HAD A DOSE OF METHADONE ON BOARD SO WAS QUIET AND SLEEPY. THE 25 X 5/8 NEEDLE WAS NEW FROM THE BOX AND ATTACHED TO THE SYRINGE AFTER THE VACCINE HAD ALREADY BEEN DRAWN UP. THE EVENT OCCURRED INTRA-OPERATIVE. ADDITIONAL INFORMATION WAS RECEIVED ON 02 AUG 2023: THE PATIENT WAS STABLE AND DISCHARGED. THE SUTURES AT THE INCISION SITE MADE TO RETRIEVE THE NEEDLE ARE HEALING WELL. THE NEEDLE WAS ATTACHED TO A BD 3 ML LUER LOCK SYRINGE. THE MEDICATION VACCINE WAS ZOETIS VANGUARD LEPTOSPIRA. THE VACCINE DOES REQUIRE REFRIGERATION BUT IS NOT VISCOUS IN NATURE. THIS WAS A ROUTINE VACCINATION

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17628208 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K121607. One submission often covers many models, so check the product and lot details in each record.

• Z-2003-2019 · Feb 8, 2019 · Terminated
  Terumo Sur-vet Needle, 25G x 5/8", Product Code 100280
• Z-1999-2019 · Feb 8, 2019 · Terminated
  Terumo Sur-vet Needle, 22G x 1", Product Code 100211
• Z-2000-2019 · Feb 8, 2019 · Terminated
  Terumo Sur-vet Needle, 22G x 3/4", Product Code 100215
• Z-2001-2019 · Feb 8, 2019 · Terminated
  Terumo Sur-vet Needle, 25G x 5/8", Product Code 100220
• Z-2006-2019 · Feb 8, 2019 · Terminated
  Terumo Needle, 30G x 1/2", Product Code NN3013R
• Z-2002-2019 · Feb 8, 2019 · Terminated
  Terumo Sur-vet Needle, 22G x 3/4", Product Code 100279
• Z-2005-2019 · Feb 8, 2019 · Terminated
  Terumo Needle, 23G x 1", Product Code NN2325R
• Z-2004-2019 · Feb 8, 2019 · Terminated
  Terumo Needle, 18G x 1", Product Code NN1825R
• Z-1998-2019 · Feb 8, 2019 · Terminated
  Terumo Sur-vet Needle, 20G x 1", Product Code 100204