McKesson 16-N251SRecalls & reported problems
Mckesson Medical-Surgical Inc. · NEEDLE, SAFETY 25GX1" (HINGED STYLE) · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 18
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 10612479244624), received between Feb 18, 2022 and Apr 10, 2026 — classified as 1 injury, 17 malfunctions.
The most frequently reported specific device problem is “Break” (6 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break6
- Decoupling3
- Contamination2
- Fail-Safe Problem2
- Fluid/Blood Leak2
- Defective Component1
- Device Damaged Prior to Use1
- Leak/Splash1
Patient problems
- No Clinical Signs, Symptoms or Conditions13
- Device Embedded In Tissue or Plaque2
- Needle Stick/Puncture2
- Insufficient Information1
Recent adverse event reports
The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 10, 2026Fluid/Blood Leak
CUSTOMER REPORTED THAT THE ITEM LEAKS WHERE NEEDLE CONNECTS. NO INJURY OCCURRED. MEDICATION WAS A VACCINE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24838702 ↗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 PRODUCTS. REPRODUCIBLE ACROSS OBSERVERS AND SITES. CERTAIN NEEDLE LOTS OF 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 24597368 ↗MalfunctionJan 21, 2026Device Damaged Prior to Use
CUSTOMER REPORTED THAT WHILE TRYING TO EXPEL AIR FROM THE NEEDLE, THEY NOTICED THE TIP PROTRUDING FROM THE SAFETY SHIELD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24129523 ↗MalfunctionJan 14, 2026Fail-Safe Problem
THE CUSTOMER REPORTED THAT WHILE TRYING TO EXPEL AIR FROM THE NEEDLE, THEY NOTICED THE TIP PROTRUDING FROM THE SAFETY SHIELD. 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 24070271 ↗MalfunctionDec 10, 2025Decoupling; Decoupling
CUSTOMER REPORTED THAT THE MEDICAL ASSISTANT DREW UP THE PENTACEL WITH THE 25G X5/8 IN SYRINGE WITH SAFETY HYPODERMIC NEEDLE 1CC AND THEN ATTACHED THE 25G X 1 INCH (MFR 16-N251S; LOT CSOD12-05) TO THE SYRINGE TO ADMINISTER THE VACCINE. WHEN GIVING THE VACCINE TO THE PATIENT THE NEEDLE BROKE OFF THE SYRINGE AND THE VACCINE SPILLED OUT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23766978 ↗MalfunctionNov 5, 2025Break; Break
IT WAS REPORTED BY THE CUSTOMER THAT WHEN GIVING THE VACCINE TO THE PATIENT THE NEEDLE BROKE OFF THE SYRINGE AND THE VACCINE SPILLED OUT. 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 23479366 ↗MalfunctionAug 13, 2025Decoupling; Fluid/Blood Leak; Decoupling; Fluid/Blood Leak
CUSTOMER REPORTED THAT THE NEEDLE HUB COULD NOT ATTACH SECURELY TO THE SYRINGE, WHICH RESULTED IN THE MEDICATION LEAKING OUT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22790978 ↗MalfunctionAug 1, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED BY THE CUSTOMER THAT THE NEEDLE NUB COULD NOT ATTACHED SECURELY TO THE SYRINGE, WHICH RESULTED IN THE MEDICATION LEAKING OUT. 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 22684929 ↗MalfunctionJul 10, 2025Contamination; Contamination
CUSTOMER REPORTED THAT WHEN THE NEEDLE IS REMOVED, IT WAS NOTICED A BLACK SPOT LEFT BEHIND FROM THE NEEDLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22466416 ↗MalfunctionJun 18, 2025Decoupling; Decoupling
CUSTOMER REPORTED THAT, AFTER THE VACCINE INJECTION, THE NEEDLE REMAINED IN THE PATIENT'S ARM WHEN THE HEALTHCARE PROVIDER ATTEMPTED TO WITHDRAW IT. FORTUNATELY, THE NEEDLE WAS SUCCESSFULLY REMOVED USING FINGERS, WITHOUT THE NEED FOR TOOLS SUCH AS TWEEZERS. IT WAS MENTIONED THAT THIS ISSUE HAS OCCURRED MULTIPLE TIMES.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 22282534 ↗MalfunctionMay 16, 2025Break; Break
CUSTOMER REPORTED THAT TWO PREVENT HT SAFETY NEEDLES OF THE SAME LOT BROKE IN PATIENTS DURING VACCINATIONS AND THE STAFF REMOVED THE PIECE WITH THEIR HANDS. NO PATIENTS WERE INJURED. THE STAFF REMOVED THE LOT FROM USE.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 22035785 ↗MalfunctionMay 16, 2025Break; Break
CUSTOMER REPORTED: THE CUSTOMER REPORTED THAT DURING THE ADMINISTRATION OF A FLU SHOT, THE NEEDLE BROKE AT THE HUB AND PENETRATED THE EMPLOYEE'S THUMB. UPON FURTHER COMMUNICATION WITH THE CUSTOMER OVER THE PHONE, IT WAS CONFIRMED THAT WHEN ATTEMPTING TO INSPECT AN UNUSED PRODUCT, THE NEEDLE ONCE AGAIN DETACHED FROM THE HUB.
Patient problems: Needle Stick/Puncture
MAUDE report 22035709 ↗MalfunctionMay 16, 2025Defective Component; Defective Component
"THE CUSTOMER REPORTED THAT THEY HAVE EXPERIENCED THREE INCIDENTS WHERE NEEDLES BENT WHEN THE SAFETY CAP WAS APPLIED POST-INJECTION. THE BENDING OCCURS BECAUSE THE NEEDLE TIP IS HITTING SOMETHING INSIDE THE SAFETY CAP INSTEAD OF MOVING SMOOTHLY AS INTENDED. NO NEEDLESTICK INJURIES HAVE RESULTED FROM THESE INCIDENTS. ALL AFFECTED STOCK HAS BEEN REMOVED FROM THE LAB, AND THE REMAINING BOXES ARE LABELED ""DO NOT USE"" PENDING FURTHER INSTRUCTIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22035685 ↗MalfunctionMay 16, 2025Break; Break
"CUSTOMER REPORTED THAT THE NEEDLE BROKE DURING INSERTION. "
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22035501 ↗MalfunctionMar 21, 2025Break; Break
IT WAS REPORTED BY THE CUSTOMER THAT TWO SAFETY NEEDLES OF THE SAME LOT BROKE IN PATIENTS DURING VACCINATIONS, THE NEEDLES WERE SAFELY REMOVED BY HAND, NO PATIENT INJURIES WERE SUSTAINED AS A RESULT OF THIS INCIDENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21661859 ↗MalfunctionJan 15, 2025Fail-Safe Problem; Fail-Safe Problem
IT WAS REPORTED BY THE CUSTOMER THAT THEY HAVE EXPERIENCED THREE INCIDENTS WHERE NEEDLES BENT WHEN THE SAFETY CAP WAS APPLIED AFTER INJECTION. THE BENDING OCCURS BECAUSE THE NEEDLE TIP IS STRIKING AN INTERNAL COMPONENT OF THE SAFETY CAP, RATHER THAN GLIDING SMOOTHLY AS INTENDED; THERE'S NO NEEDLESTICK INJURIES HAVE RESULTED FROM THESE INCIDENTS. 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 21160722 ↗InjuryNov 27, 2024Break; Break
IT WAS REPORTED BY THE CUSTOMER THAT AFTER USING THE NEEDLE TO ADMINISTER A FLU SHOT, THE NEEDLE BROKE AT THE HUB AND EMPLOYEE RECEIVED A SMALL SCRATCH TO HIS RIGHT PINKIE FINGER.
Patient problems: Needle Stick/Puncture
MAUDE report 20799082 ↗MalfunctionFeb 18, 2022Product Quality Problem
THE SAFETY CAP IS HARD TO CLOSE OVER EXPOSED NEEDLE CAUSING POTENTIAL NEEDLE STICK AS YOU PUSH DOWN TO COVER NEEDLE AFTER USE. WE RECEIVED SEVERAL BOXES AND ALL ARE THE SAME. PLASTIC COVER APPEARS TO BE SMALL AND REQUIRES A FORCE TO CLOSE - POTENTIALLY SLIDING FINGER OVER NEEDLE
Patient problems: Insufficient Information
MAUDE report 13558887 ↗
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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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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