McKesson 16-N2558SRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10612479244655), received between Mar 27, 2025 and Mar 13, 2026 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 13, 2026Contamination

  CUSTOMER REPORTED THAT THE NEEDLES ARE LEAVING A GRAY/SILVER METALLIC RESIDUE ON PATIENTS' SKIN. PRESENT BEFORE VIAL STOPPER PUNCTURE. NOT OBSERVED IN MOST OTHER LOTS OF SAME PRODUCT. REPRODUCIBLE ACROSS OBSERVERS AND SITES. CERTAIN NEEDLE LOTS EXHIBIT VISIBLE GRAY/DARK RESIDUE DIRECTLY OUT OF UNOPENED STERILE PACKAGING. WHEN WIPED WITH STERILE WHITE GAUZE OR TISSUE, A GRAY SMEAR IS PRODUCED. WHEN USED FOR INJECTION (SIMULATION AND PATIENT CARE), A VISIBLE DARK MARK IS AT THE INJECTION PATH. WHEN REPRODUCING IN ONE MEDIA WE WERE ABLE TO CUT INTO, THE DARK MARK TRACKED THROUGH THE MEDIA ALONG THE INJECTION PATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24589491 ↗
• MalfunctionFeb 17, 2026Break; Decoupling

  CUSTOMER REPORTED THAT ,ON OCCASION THE NEEDLE COMES OFF (DOES NOT BREAK) AND IN ONE INCIDENT STAYS STUCK IN THE PATIENT. NO INJURY OCCURRED. ON OTHER OCCASIONS, THE NEEDLE HAS BROKEN AT THE HUB ALSO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24363705 ↗
• MalfunctionMay 16, 2025Material Twisted/Bent; Material Twisted/Bent

  CUSTOMER REPORTED RETURNING THE NEEDLE DUE TO MALFUNCTION IN THE SAFETY FEATURE, WHICH DOES NOT CLOSE PROPERLY. ON (B)(6) 2025, THE CUSTOMER RESPONDED TO THE PROBING QUESTIONS AND CONFIRMED THAT THIS ISSUE WAS OBSERVED WITH A FEW NEEDLES, RESULTING IN AN EMPLOYEE INJURY. THEY FURTHER EXPLAINED THAT WHEN CLOSING OF THE SAFETY DEVICE, THE NEEDLE TENDS TO BEND AND PIERCE THROUGH THE ORANGE SAFETY COVER. UPDATE: THE CUSTOMER CONFIRMED THAT WHEN CLOSING OF THE SAFETY DEVICE, THE NEEDLE TENDS TO BEND AND PIERCE THROUGH THE ORANGE SAFETY COVER. THERE WAS ONE INCIDENT WHERE THIS RESULTED IN A NEEDLESTICK TO AN EMPLOYEE. NO TREATMENT WAS REQUIRED.

  Patient problems: Needle Stick/Puncture

  MAUDE report 22035481 ↗
• InjuryMar 27, 2025Fail-Safe Problem; Fail-Safe Problem

  THE CUSTOMER REPORTED THAT THE NEEDLES EXPERIENCED A MALFUNCTION IN THE SAFETY FEATURE, WHICH DOES NOT CLOSE PROPERLY. THIS ISSUE CAUSES THE NEEDLE TO BEND AND PIERCE THROUGH THE SAFETY COVER. THERE WAS ONE INCIDENT WHERE THIS RESULTED IN A NEEDLESTICK TO AN EMPLOYEE.

  Patient problems: Needle Stick/Puncture

  MAUDE report 21709700 ↗