McKesson 16-NBC21GSRecalls & reported problems
Mckesson Medical-Surgical Inc. · Safety Blood Collection Needle 21G x 1 1/4 in (48/box, 50/cs) · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 20612479244331), received between Apr 8, 2024 and Jan 10, 2025 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Fail-Safe Did Not Operate” (2 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
- Fail-Safe Did Not Operate2
- Component Incompatible1
- Fail-Safe Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 10, 2025Fail-Safe Did Not Operate; Fail-Safe Did Not Operate
THE SAFETY MECHANISM ON THESE NEEDLES HAS BEEN PROBLEMATIC, WITH COMPLAINTS ABOUT IT TILTING TO THE SIDE AND LEAVING THE NEEDLE EXPOSED. TECHNICIANS HAVE EXPRESSED CONCERNS ABOUT ACCIDENTALLY GETTING INJURED AND HAVE RESORTED TO NOT ACTIVATING THE MECHANISM. ADDITIONALLY, THE SAFETY MECHANISM DOES NOT OPEN SMOOTHLY OR FULLY, CAUSING INCONVENIENCE DURING BLOOD DRAWING; ALSO, IT HAS BEEN OBSERVED THAT IT CAN PUSH OFF SOME OF THE LARGER TUBES OFF THE NEEDLE WHILE THEY FILLED WITH BLOOD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21132247 ↗MalfunctionJan 10, 2025Fail-Safe Did Not Operate; Fail-Safe Did Not Operate
THE SAFETY MECHANISM ON THESE NEEDLES HAS BEEN PROBLEMATIC, WITH COMPLAINTS ABOUT IT TILTING TO THE SIDE AND LEAVING THE NEEDLE EXPOSED. TECHNICIANS HAVE EXPRESSED CONCERNS ABOUT ACCIDENTALLY GETTING INJURED AND HAVE RESORTED TO NOT ACTIVATING THE MECHANISM. ADDITIONALLY, THE SAFETY MECHANISM DOES NOT OPEN SMOOTHLY OR FULLY, CAUSING INCONVENIENCE DURING BLOOD DRAWING; ALSO, IT HAS BEEN OBSERVED THAT IT CAN PUSH OFF SOME OF THE LARGER TUBES OFF THE NEEDLE WHILE THEY FILLED WITH BLOOD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21132171 ↗MalfunctionSep 27, 2024Component Incompatible; Component Incompatible
THE CUSTOMER CLAIMS THAT THE VACUTAINER TUBES POP OFF OF THE NEEDLE DURING THE DRAWING PROCESS AND IT HAS CAUSED THEM TO HAVE TO STICK PATIENTS TWICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20320702 ↗MalfunctionApr 8, 2024Fail-Safe Problem; Fail-Safe Problem
IT WAS REPORTED BY THE CUSTOMER THAT COMPLAINTS HAD BEEN RECEIVED REGARDING THE NEEDLES BEING PROBLEMATIC DUE TO IT TILTING TO THE SIDE AND LEAVING THE NEEDLE EXPOSED. TECHNICIANS HAVE EXPRESSED CONCERNS ABOUT ACCIDENTALLY GETTING INJURED AND HAVE RESORTED TO NOT ACTIVATING THE MECHANISM. ADDITIONALLY, THE SAFETY MECHANISM DOES NOT OPEN SMOOTHLY OR FULLY, CAUSING INCONVENIENCE DURING BLOOD DRAWING AND SOME OF THE LARGER TUBES PUSH OFF DURING A BLOOD DRAW. THIS WAS REPORTED TO HAVE OCCURRED WITH THE MAJORITY OF THE BOX ON HAND. 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 19059919 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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