McKesson 16-N2558Recalls & reported problems
Mckesson Medical-Surgical Inc. · Needle, Hypodermic TW, 25GX 5/8 · Class 2
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10612479206790), received between Mar 13, 2025 and Oct 27, 2025 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Complete Blockage” (5 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
Most reported problems
Device problems
- Complete Blockage5
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions6
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 27, 2025Break; Break
THE CUSTOMER REPORTED THAT THE NEEDLE WOULD BREAK WHILE INJECTING PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23388304 ↗MalfunctionAug 22, 2025Complete Blockage; Complete Blockage
THE COMPLAINT REPORTED THAT THE NEEDLES FAILED TO INJECT INTO THE PATIENT DUE TO CLOGGING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22871889 ↗MalfunctionAug 7, 2025Complete Blockage; Complete Blockage
THE CUSTOMER REPORTED THAT THE NEEDLE WAS CLOGGED AND FAILED TO DISPENSE THE MEDICATION. NO PATIENT INJURIES WERE REPORTED AS A RESULT OF THIS ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22736321 ↗MalfunctionJul 23, 2025Complete Blockage; Complete Blockage
IT WAS REPORTED BY THE CUSTOMER THAT THE NEEDLES FAILED TO INJECT THE MEDICATION INTO THE PATIENT DUE TO CLOGGING. NO PATIENT INJURIES WERE SUSTAINED AS A RESULT OF THIS INCIDENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22576791 ↗MalfunctionMar 14, 2025Complete Blockage; Complete Blockage
IT HAS BEEN REPORTED THAT THIS PARTICULAR LOT OF NEEDLES IS NOT EFFECTIVELY ADMINISTERING MEDICATIONS. THE CUSTOMER INDICATED THAT THE NEEDLES FROM THIS LOT WERE UNABLE TO PUSH METHYLPREDNISOLONE AND OTHER DRUGS THROUGH AS EXPECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21604947 ↗MalfunctionMar 13, 2025Complete Blockage; Complete Blockage
IT WAS REPORTED BY THE CUSTOMER THAT THE NEEDLES FROM THIS LOT NUMBER WERE NOT PUSHING METHYLPREDNISOLONE AND OTHER DRUGS THROUGH. NO INFORMATION WAS RECEIVED REGARDING ANY SERIOUS INJURY AS A RESULT OF THIS PRODUCT TISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21591886 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.