TERUMO NN1825RRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 34806017511839), received between Apr 3, 2019 and Dec 15, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (2 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. How this data works · Data updated Oct 13, 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.

• MalfunctionDec 15, 2021Corroded; Contamination /Decontamination Problem; Corroded; Contamination /Decontamination Problem

  THE USER FACILITY REPORTED THAT THE STAFF SAID THAT THE NEEDLE WAS DIFFICULT TO USE AND NOTICED RUST ON THE NEEDLE. IT WAS REPORTED THAT IT WAS NOT A PENETRATION ISSUE. THE STAFF STATED IT WAS DIFFICULT TO INJECT THE FLUIDS THROUGH, ALMOST AS IF IT WAS CLOGGED. LOOKING CLOSELY AT THE NEEDLE, THEY NOTICED DISCOLORATION, THAT APPEARED TO BE RUST. ONE WAS OPENED AND A STAFF FINGER RAN OVER IT AND THE DISCOLORATION TRANSFERRED TO THE FINGER. THEY WERE CONCERNED THAT CHUNKS OF THE RUST WERE CLOGGING THE NEEDLES. THEY CHECKED THE STOCK IN BOTH BUILDINGS, AND THIS BOX LOT AND TWO PIECES WERE THE ONLY ONES THEY IDENTIFIED WITH THE ISSUES. DIFFICULT FLUID DELIVERY AND RUST. THEY STOPPED USING THIS LOT AND HAVE NOT HAD THE ISSUE SINCE. NO ANIMALS WERE HARMED DUE TO ISSUE. ADDITIONAL INFORMATION WAS RECEIVED ON 07DECEMBER 2021: THE TECH HAD JUST OPENED THE DEVICE, WHEN DISCOLORATION WAS NOTED. THE NEEDLE WAS NOT USED DURING ANY ANIMAL PROCEDURE. THEY COULD NOT CONFIRM EXACT RECEIPT DATE OF PRODUCT, OR STORAGE TIME BUT STATED IT COULD NOT HAVE BEEN IN FACILITY FOR MORE THAN 2 MONTHS PRIOR TO THE ISSUE. ALSO, THE NEEDLES ARE DISTRIBUTED BY TECHS WHO MOVE THE NEW PRODUCT FROM LOCKED MEDICAL STOR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13014314 ↗
• MalfunctionDec 15, 2021Corroded; Contamination /Decontamination Problem; Corroded; Contamination /Decontamination Problem

  THE USER FACILITY REPORTED THAT THE STAFF SAID THAT THE NEEDLE WAS DIFFICULT TO USE AND NOTICED RUST ON THE NEEDLE. IT WAS REPORTED THAT IT WAS NOT A PENETRATION ISSUE. THE STAFF STATED IT WAS DIFFICULT TO INJECT THE FLUIDS THROUGH, ALMOST AS IF IT WAS CLOGGED. LOOKING CLOSELY AT THE NEEDLE, THEY NOTICED DISCOLORATION, THAT APPEARED TO BE RUST. ONE WAS OPENED AND A STAFF FINGER RAN OVER IT AND THE DISCOLORATION TRANSFERRED TO THE FINGER. THEY WERE CONCERNED THAT CHUNKS OF THE RUST WERE CLOGGING THE NEEDLES. THEY CHECKED THE STOCK IN BOTH BUILDINGS, AND THIS BOX LOT AND TWO PIECES WERE THE ONLY ONES THEY IDENTIFIED WITH THE ISSUES. DIFFICULT FLUID DELIVERY AND RUST. THEY STOPPED USING THIS LOT AND HAVE NOT HAD THE ISSUE SINCE. NO ANIMALS WERE HARMED DUE TO ISSUE. ADDITIONAL INFORMATION WAS RECEIVED ON 07DECEMBER 2021: THE TECH HAD JUST OPENED THE DEVICE, WHEN DISCOLORATION WAS NOTED. THE NEEDLE WAS NOT USED DURING ANY ANIMAL PROCEDURE. THEY COULD NOT CONFIRM EXACT RECEIPT DATE OF PRODUCT, OR STORAGE TIME BUT STATED IT COULD NOT HAVE BEEN IN FACILITY FOR MORE THAN 2 MONTHS PRIOR TO THE ISSUE. ALSO, THE NEEDLES ARE DISTRIBUTED BY TECHS WHO MOVE THE NEW PRODUCT FROM LOCKED MEDICAL STOR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13012452 ↗
• MalfunctionApr 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE USER FACILITY REPORTED THAT A PATIENT RECEIVED AN INJECTION AND MIGHT HAVE GOTTEN AN INFECTION. PATIENT IS IN GOOD CONDITION POST TREATMENT FOR INJECTION SITE INFECTION. PATIENT'S ORIGINAL SYMPTOMS WERE RESOLVED, AS WELL AS THE SWELLING AT THE INJECTION SITE. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2019: THE (B)(6), NEUTERED, MALE PIT-BULL, WAS PRESENTED WITH VOMITING AND DIARRHEA ON (B)(6) 2019. THE DOG WAS TREATED WITH SUB-Q FLUIDS FOR SYMPTOMS AND WITH INJECTIONS OF METRONIDAZOLE AND WAS RELEASED. ON (B)(6) 2019 THE FACILITY WAS CONTACTED TO THAT THE INJECTION SITE AREA WAS SWOLLEN AND HOT. THE ANIMAL WAS RETURNED TO FACILITY FOR TREATMENT INCLUDING CULTURE OF INJECTION SITE AND PAIN MEDICATION. NO ANTIBIOTICS WERE GIVEN AS HE WAS ALREADY BEING TREATED WITH METRONIDAZOLE. THE AREA CULTURE TESTED POSITIVE FOR TWO TYPES OF BACTERIAL ORGANISMS. THE PATIENT WAS RELEASED THE SAME DAY. THE AREA WAS RESOLVED AFTER SEVERAL DAYS AS REPORTED IN THE FOLLOW UP APPOINTMENT.

  Patient problems: Bacterial Infection; Swelling

  MAUDE report 8478230 ↗

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