McKesson 26558Recalls & reported problems
Mckesson Medical-Surgical Inc. · NEEDLE, SAFETY PREVENT M 25GX5 · Class 2
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10612479201351), received between Aug 26, 2020 and Feb 10, 2021 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Connection Problem” (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
Device problems
- Connection Problem1
- Device Contamination with Chemical or Other Material1
- Fail-Safe Problem1
- Fluid/Blood Leak1
Patient problems
- Needle Stick/Puncture1
- No Clinical Signs, Symptoms or Conditions1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 10, 2021Fluid/Blood Leak; Connection Problem; Fluid/Blood Leak; Connection Problem
THE CUSTOMER REPORTED THAT THEY HAD ISSUE WITH THE MEDICATION LEAKING FROM THE SYRINGE WHERE THE NEEDLE IS ATTACHED TO THE SYRINGE. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER STATED THAT THERE WERE NO VISIBLE CONNECTION ISSUES. THE CUSTOMER TESTED THE NEEDLE TO CHECK IF IT WAS A CONNECTION ISSUE, SHE ATTACHED A SALINE FLUSH SYRINGE ONTO ONE OF THE SAME NEEDLE FROM THE SAME LOT NUMBER, AS SHE WAS FLUSHING THE SALINE THROUGH THE NEEDLE IT WAS NOTED TO SLOWLY LEAK OUT OF THE CONNECTION SITE. THE NEEDLE SCREWED ON TO THE SYRINGE WITHOUT DIFFICULTY AND IT WAS ENSURED THAT THE NEEDLE WAS SCREWED ON TO THE SYRINGE COMPLETELY. THE CUSTOMER FURTHER STATED THAT WHILE ADMINISTERING A MEDICATION TO THE PATIENT, LEAKING WAS NOTICED AT THE NEEDLE-CONNECTION SITE. IT WAS A B-12 INJECTION(BRIGHT PINK IN COLOR), SO IT WAS EASY TO SEE THAT THE MEDICATION WAS LEAKING. THERE WAS NO PATIENT HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11311324 ↗MalfunctionOct 2, 2020Fail-Safe Problem; Fail-Safe Problem
THE NEEDLES SEEM TO BE MORE FLIMSY AND THE SAFETY FEATURE DOES NOT SECURELY LOCK LEAVING PART OF THE NEEDLE EXPOSED, WHICH HAS LED TO NEEDLESTICKS.
Patient problems: Needle Stick/Puncture
MAUDE report 10623027 ↗MalfunctionAug 26, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
CUSTOMER REPORTS: THE NEEDLES HAVE PLASTIC PARTICLES INSIDE THE NEEDLE SHEATH AS WELL AS ON THE NEEDLES.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10453990 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.