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McKesson 16-N25105Recalls & reported problems

Mckesson Medical-Surgical Inc. · Needle, Hypodermic TW, 25GX1 1/2 · Class 2

Adverse event reports
20
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 10612479206769), received between Apr 14, 2024 and Sep 23, 2026 — classified as 1 injury, 19 malfunctions.

The most frequently reported specific device problem is “Complete Blockage” (8 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. How this data works · Data updated Oct 13, 2026.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 1 reportsMay 2024: 0 reportsJun 2024: 1 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 1 reportsFeb 2025: 0 reportsMar 2025: 3 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 1 reportsAug 2025: 5 reportsSep 2025: 1 reportsOct 2025: 1 reportsNov 2025: 0 reportsDec 2025: 1 reportsJan 2026: 2 reportsFeb 2026: 1 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 1 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 1 reportsOct 2026: 0 reports2024202520265
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Complete Blockage8
  • Partial Blockage6
  • Break2
  • Insufficient Device Problem Information2
  • Component Incompatible1
  • Obstruction of Flow1

Patient problems

  • No Clinical Signs, Symptoms or Conditions18
  • Foreign Body In Patient2

Recent adverse event reports

The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

  • MalfunctionSep 23, 2026Component Incompatible

    Customer reported having a lot of issues with the needles not working with the syringes.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50864352 ↗
  • MalfunctionJun 14, 2026Obstruction of Flow

    CUSTOMER HAD MULTIPLE NEEDLES THAT WERE CLOGGING WITH THIS LOT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25497860 ↗
  • MalfunctionFeb 6, 2026Complete Blockage

    IT WAS REPORTED BY THE CUSTOMER THAT NEEDLES CLOGGING OR BECOMING BLOCKED AFTER PUSHING HALF THE RX THROUGH. NO INFORMATION WAS RECEIVED REGARDING ANY SERIOUS INJURY AS A RESULT OF THIS PRODUCT ISSUE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24278239 ↗
  • MalfunctionJan 24, 2026Break

    WE HAD AN INCIDENT WHERE, DURING LOCAL ANESTHETIC INFILTRATION, A MCKESSON NEEDLE BROKE OFF AND WAS RETAINED INSIDE A PATIENT. WE HAVE HAD TO S END THE PATIENT FOR URGENT REFERRAL TO GENERAL SURGERY TO HAVE THE NEEDLE REMOVED.

    Patient problems: Foreign Body In Patient

    MAUDE report 24173118 ↗
  • InjuryJan 14, 2026Break

    IT WAS REPORTED THAT A NEEDLE BROKE OFF AT THE HUB AND WAS RETAINED INSIDE A PATIENT.

    Patient problems: Foreign Body In Patient

    MAUDE report 24066656 ↗
  • MalfunctionDec 25, 2025Partial Blockage; Partial Blockage

    THE CUSTOMER REPORTED THAT THE NEEDLES INJECT APPROXIMATELY 0.5 TO 1 ML AND THEN STOP, REQUIRING MULTIPLE NEEDLE INSERTIONS TO COMPLETE THE INJECTION. NO INFORMATION WAS RECEIVED REGARDING ANY SERIOUS INJURY AS A RESULT OF THIS PRODUCT ISSUE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23892268 ↗
  • MalfunctionOct 17, 2025Partial Blockage; Partial Blockage

    THE CUSTOMER REPORTED THAT THE NEEDLES BECOME PLUGGED MID-PROCEDURE. THEY ATTEMPTED TO SIFT THROUGH VARIOUS NEEDLES TO IDENTIFY THE ISSUE. NO INFORMATION WAS RECEIVED REGARDING ANY SERIOUS INJURY AS A RESULT OF THIS PRODUCT ISSUE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23320964 ↗
  • MalfunctionSep 15, 2025Complete Blockage; Complete Blockage

    THE CUSTOMER REPORTED THAT THE NEEDLES WOULD NOT ALLOW FLUID TO EXIT TO BE INJECTED. NO INFORMATION WAS RECEIVED REGARDING ANY SERIOUS INJURY AS A RESULT OF THIS PRODUCT ISSUE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23048892 ↗
  • MalfunctionAug 28, 2025Complete Blockage; Complete Blockage

    CUSTOMER FEEDBACK SHOWS THAT SOME HYPODERMIC NEEDLES ARE UNABLE TO ALLOW THE MEDICATION TO PASS THROUGH. ALTHOUGH NOT ALL HYPODERMIC NEEDLES ARE AFFECTED, WHEN THERE IS A PROBLEM, CUSTOMERS WILL REPLACE THE NEEDLES AND CONTINUE TO OPERATE UNTIL ONE CAN BE USED NORMALLY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22912034 ↗
  • MalfunctionAug 28, 2025Complete Blockage; Complete Blockage

    IT WAS REPORTED THAT THE NEEDLE IS NOT ALLOWING THE MEDICATION TO PASS THROUGH; THEY FURTHER EXPLAINED THAT WHENEVER THEY TRY AND PUSH OMNIPA QUE OR DEPOMEDROL THROUGH THE NEEDLE, IT WOULD NOT INJECT, MAINLY FOR CAUDAL EPIDURALS.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22911999 ↗
  • MalfunctionAug 7, 2025Partial Blockage; Partial Blockage

    THE CUSTOMER REPORTED THAT SOME RESISTANCE WHEN ADMINISTERING MEDICATION THROUGH THE NEEDLE. THEY ARE INITIALLY ABLE TO BEGIN THE INJECTION, BUT AT A CERTAIN POINT, THE FLOW STOPS AND THEY ARE UNABLE TO CONTINUE. TO COMPLETE THE INJECTION, THEY HAVE BEEN SWITCHING TO A DIFFERENT NEEDLE. NO INFORMATION WAS RECEIVED REGARDING ANY SERIOUS INJURY AS A RESULT OF THIS PRODUCT ISSUE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22736323 ↗
  • MalfunctionAug 7, 2025Partial Blockage; Partial Blockage

    THE CUSTOMER REPORTED THAT SOME RESISTANCE WHEN ADMINISTERING MEDICATION THROUGH THE NEEDLE. THEY ARE INITIALLY ABLE TO BEGIN THE INJECTION, BUT AT A CERTAIN POINT, THE FLOW STOPS AND THEY ARE UNABLE TO CONTINUE. TO COMPLETE THE INJECTION, THEY HAVE BEEN SWITCHING TO A DIFFERENT NEEDLE. NO INFORMATION WAS RECEIVED REGARDING ANY SERIOUS INJURY AS A RESULT OF THIS PRODUCT ISSUE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22736320 ↗
  • MalfunctionAug 1, 2025Complete Blockage; Complete Blockage

    THE CUSTOMER REPORTED THAT SOME NEEDLES DO NOT ALLOW MEDICATION TO PASS THROUGH. WHILE NOT ALL NEEDLES ARE AFFECTED, WHEN THE ISSUE OCCURS, THE CUSTOMER REPLACES THE NEEDLE AND CONTINUES THE PROCESS UNTIL ONE FUNCTION PROPERLY. NO INFORMATION WAS RECEIVED REGARDING ANY SERIOUS INJURY AS A RESULT OF THIS PRODUCT ISSUE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22684921 ↗
  • MalfunctionJul 8, 2025Complete Blockage; Complete Blockage

    THE CUSTOMER REPORTED THAT THE NEEDLES DID NOT ALLOW THE MEDICATION TO FLOW THROUGH, WHICH OCCURRED ON A FEW OCCASIONS. NO PATIENT INJURIES WERE REPORTED AS A RESULT OF THIS ISSUE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22433574 ↗
  • MalfunctionMar 21, 2025Complete Blockage; Complete Blockage

    IT WAS REPORTED BY THE CUSTOMER THAT THE INJECTION FLUID WILL NOT GO THROUGH THE NEEDLE. NO INFORMATION WAS RECEIVED REGARDING A SERIOUS INJURY AS A RESULT OF THIS PRODUCT ISSUE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21662277 ↗
  • MalfunctionMar 14, 2025Complete Blockage; Complete Blockage

    IT WAS REPORTED BY THE CUSTOMER THAT THE INJECTION FLUID WILL NOT GO THROUGH NEEDLE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21604943 ↗
  • MalfunctionMar 12, 2025Partial Blockage; Partial Blockage

    IT WAS REPORTED BY THE CUSTOMER THAT THE INJECTION FLUID WILL NOT GO THROUGH THE NEEDLE. NO INFORMATION WAS RECEIVED REGARDING A SERIOUS INJURY AS A RESULT OF THIS PRODUCT ISSUE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21583896 ↗
  • MalfunctionJan 14, 2025Partial Blockage; Partial Blockage

    IT WAS REPORTED BY THE CUSTOMER THAT THE NEEDLES ARE UNABLE TO DELIVER THE FULL AMOUNT OF MEDICATION IN A SINGLE INJECTION, REQUIRING MULTIPLE NEEDLE CHANGES TO COMPLETE THE PROCESS. THEY CONFIRMED THAT THERE IS NO LEAKAGE OR DOSAGE ISSUES. ADDITIONALLY, NO INFORMATION WAS RECEIVED REGARDING A SERIOUS INJURY AS A RESULT OF THIS PRODUCT ISSUE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21147051 ↗
  • MalfunctionJun 24, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

    IT WAS CLAIMED THAT THE DOCTOR ADMINISTERED AN INJECTION TO A PATIENT USING GEL-ONE AND A 25 GAUGE NEEDLE, HOWEVER, THE NEEDLE WAS FAULTY AND BECAME DISCONNECTED DURING THE INJECTION PROCESS, RESULTING IN A MEDICATION SPRAYING INTO THE AIR INSTEAD OF BEING DELIVERED TO THE PATIENT'S KNEE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19592104 ↗
  • MalfunctionApr 14, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

    THE CUSTOMER REPORT THAT THE MEDICINE CAN NOT PASS THE CANNULA.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19102930 ↗

Other Needle, Hypodermic, Single Lumen devices

All Needle, Hypodermic, Single Lumen devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.