Magellan 8881850310Recalls & reported problems
Cardinal Health, Inc. · Hypodermic Safety Needle · Class 2
All models of Magellan (29)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Cardinal Health hypodermic safety needle is used for injections, including vaccines, with a sliding safety shield meant to cover the needle after use. The 43 reports mostly describe liquid or blood leaking from the needle, the needle tip breaking or cracking, and the safety mechanism not sliding shut so the needle stays exposed after use. Two injuries and no deaths are reported. There are no recalls naming this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 43
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 43 adverse event reports that list this exact device (DI 10884521000544), received between May 15, 2017 and Dec 23, 2025 — classified as 2 injuries, 41 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (24 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
- Fluid/Blood Leak24
- Break7
- Device Contamination with Chemical or Other Material5
- Crack4
- Device Contaminated During Manufacture or Shipping3
- Fail-Safe Problem3
- Leak/Splash2
- Air/Gas in Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions27
- No Consequences Or Impact To Patient6
- Insufficient Information4
- Needle Stick/Puncture3
- No Known Impact Or Consequence To Patient3
- No Patient Involvement3
Recent adverse event reports
The 25 most recent of 43 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 23, 2025Fail-Safe Problem; Fail-Safe Problem
THE CUSTOMER REPORTED THAT WHILE GIVING VACCINES USING THESE NEEDLES, THE NEEDLES DID NOT SLIDE AND CLOSE ALL THE WAY, CAUSING THE MAS TO GET STUCK WITH THE NEEDLE. THERE HAVE BEEN INSTANCES TOO, WHILE THE MAS GIVE VACCINES WITH ONE HAND, GO TO PICK UP ANOTHER VACCINE, AND FIND THAT THE NEEDLE THEY THOUGHT THEY SLID CLOSE, IS ACTUALLY NOT CLOSED AT ALL, AND EXPOSED AFTER USE. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2025 STATED THAT ONE MA WAS STUCK WHILE PREPPING VACCINES. NO INTERVENTION OR TESTING WAS REQUIRED AS IT OCCURRED DURING PREPPING VACCINE.
Patient problems: Needle Stick/Puncture
MAUDE report 23882599 ↗MalfunctionFeb 18, 2025Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT THEY INJECTED DEPOT TO RIGHT DELTOID AS REQUESTED BY PATIENT. WHILST DEPRESSING THE SYRINGE, MEDICATION BEGAN LEAKING FROM THE HYPODERMIC SAFETY NEEDLE DOWN THE PATIENTS ARM. IT APPEARED THE MEDICATION WAS LEAKING OUT FROM THE PLASTIC PART OF THE DEVICE BEFORE ENTERING THE STEEL LUMEN OF THE NEEDLE AS THE MEDICATION WAS BEING PUSHED THROUGH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21396143 ↗MalfunctionFeb 18, 2025Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THEY INJECTED DEPOT MEDICATION TO RIGHT DELTOID. WHILST DEPRESSING THE SYRINGE, MEDICATION BEGAN LEAKING FROM THE HYPODERMIC SAFETY NEEDLE DOWN THE PATIENT'S ARM. IT APPEARED THE MEDICATION WAS LEAKING OUT FROM THE PLASTIC PART OF THE DEVICE BEFORE ENTERING THE STEEL LUMEN OF THE NEEDLE AS THE MEDICATION WAS BEING PUSHED THROUGH. IT WAS ALSO STATED THAT WHEN THE NEEDLE IS PRIMED WITH THE MEDICATION, NO LEAKING OCCURS AT THIS TIME. IT IS WHEN THE NEEDLE IS INSERTED INTO THE INTRAMUSCULAR AREA AND INJECTED UNDER PRESSURE THAT THE LEAKING HAS OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21393305 ↗MalfunctionOct 23, 2024Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT SUSPENSION ESCAPES FROM THE SCREW CAP WHEN THE PRE-FILLED SYRINGE (PFS) IS VENTED. THE PFS WAS INSPECTED AND THE POINT AT WHICH THE SUSPENSION LEAKED AROUND THE SCREW CAP WAS VISIBLE. THE PFS APPEARS TO HAVE BEEN ASSEMBLED CORRECTLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20517191 ↗MalfunctionOct 17, 2024Fluid/Blood Leak; Detachment of Device or Device Component; Fluid/Blood Leak; Detachment of Device or Device Component
THE CUSTOMER REPORTED THAT THE PRE-FILLED SYRINGE LEAKING AT THE THREAD. THE USER TRIED TO STOP THE INJECTION FROM LEAKING FURTHER BY TIGHTENING THE NEEDLE MORE FIRMLY THEN THE CONNECTING PART BETWEEN THE NEEDLE AND SYRINGE HAD SUBSEQUENTLY BROKEN OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20469983 ↗MalfunctionOct 17, 2024Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT WHEN THE PEN WAS BEING ADMINISTERED TO THE PATIENT, POWDER WAS COMING OUT OF THE END SO COULD NOT BE ADMINISTERED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20469958 ↗MalfunctionOct 15, 2024Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT THE NURSE ATTEMPTED TO ADMINISTER THE DOSE TO AN INDIVIDUAL PATIENT AND FLUID FROM THE SYRINGE LEAKED AT THE CONNECTION POINT BETWEEN THE NEEDLE AND SYRINGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20450101 ↗MalfunctionOct 14, 2024Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER STATED THAT THE NURSE COULD NOT GET THE DROP AT THE END OF THE SYRINGE BEFORE INJECTING, AT WHICH POINT SHE REALIZED THERE WAS A LEAK AND THAT THE PRODUCT WAS DRIPPING ONTO HER HANDS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20447856 ↗MalfunctionOct 14, 2024Break; Break
THE CUSTOMER REPORTED THAT THE CANNULA IS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20442568 ↗MalfunctionOct 14, 2024Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT THE SUSPENSION LEAKS OUT AT THE SIDE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20440953 ↗MalfunctionOct 14, 2024Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT THE SUSPENSION LEAKS OUT BETWEEN THE NEEDLE AND SYRINGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20440444 ↗MalfunctionOct 7, 2024Break; Fluid/Blood Leak; Break; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT THE NEEDLE HUB BROKE WHICH RESULTED IN LEAKAGE AT THE LUER CONNECTION. SOME OF THE MEDICATION LEAKED DOWN. NURSE REPORTED DURING ADMINISTRATION TO OBSERVE A CRACK IN THE NEEDLE SHAFT. FLUID LEAKING FROM THE SIDE. THE CRACK OCCURRED AT THE BASE OF THE NEEDLE (HUB) WHEN IT WAS SCREWED INTO THE SYRINGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20393010 ↗MalfunctionOct 7, 2024Break; Fluid/Blood Leak; Break; Fluid/Blood Leak
THE CUSTOMER REPORTED THE NEEDLE HUB BROKE WHICH RESULTED IN LEAKAGE AT THE LUER CONNECTION. AFTER ATTACHING THE NEEDLE TO THE SYRINGE HE HEARD A NOISE AND NOTICED THAT THE PLASTIC SHEATH AROUND THE NEEDLE WAS CRACKED AND THAT PRODUCT WAS FLOWING OUT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20392761 ↗MalfunctionOct 7, 2024Break; Fluid/Blood Leak; Fail-Safe Problem; Break; Fluid/Blood Leak; Fail-Safe Problem
THE CUSTOMER REPORTED THAT THE NEEDLE HUB BROKE WHICH RESULTED IN LEAKAGE AT THE LUER CONNECTION. THE TIP OF THE NEEDLE WAS TWISTED AND THE SAFETY WAS CUT IN HALF AT THE BASE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20392682 ↗MalfunctionOct 7, 2024Break; Fluid/Blood Leak; Break; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT THE NEEDLE HUB BROKE WHICH RESULTED IN LEAKAGE AT THE LUER CONNECTION. THE SUSPENSION LEAKED FROM THE NEEDLE HUB. WHEN THE NURSE SCREWED THE NEEDLE TO THE SYRINGE TIP AND WANTED TO PURGE, THE LIQUID CAME OUT FROM THE SIDE AT THE BLUE PART OF THE NEEDLE. THE THREAD IS BROKEN/BROKEN AT THE JOINT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20392482 ↗MalfunctionOct 7, 2024Break; Fluid/Blood Leak; Break; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT THE NEEDLE HUB BROKE WHICH RESULTED IN LEAKAGE AT THE LUER CONNECTION. THE SYRINGE COULD NOT BE USED DUE TO A PRODUCT LEAK. A SLIGHT CRACKING NOISE WAS HEARD WHEN THE CANNULA WAS PLACED ON THE SYRINGE. THE SYRINGE LEAKED. THERE IS A CRACK IN THE NEEDLE TIP BETWEEN THE NEEDLE AND THE SCREW THREAD. THE SYRINGE BROKE BETWEEN THE NEEDLE AND THE START OF THE SYRINGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20392304 ↗MalfunctionOct 7, 2024Break; Fluid/Blood Leak; Break; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT THE NEEDLE HUB BROKE WHICH RESULTED IN LEAKAGE AT THE LUER CONNECTION. THE PRODUCT LEAKS FROM THE NEEDLE SIDE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20390530 ↗MalfunctionAug 28, 2024Crack; Crack
THE CUSTOMER REPORTED THAT WHEN THE NEEDLE WAS ATTACHED TO THE SYRINGE, THERE WAS A SMALL NOISE. WHEN SHE STARTED TO INJECT, THE PRODUCT ESCAPED FROM THE SYRINGE AND BUBBLES APPEARED BETWEEN THE SYRINGE AND THE NEEDLE. THE NURSE STOPPED THE TREATMENT AND FOUND THAT THE NEEDLE PROTECTION HAD LOST A PIECE OF PLASTIC AND WAS CRACKED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20085219 ↗MalfunctionJun 11, 2024Crack; Crack
THE CUSTOMER REPORTED A 23G NEEDLE WAS OBSERVED TO HAVE A CRACK IN THE PLASTIC PART OF THE NEEDLE. RESIDUES OF A DRY, WHITE SOLUTION WERE OBSERVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19515010 ↗MalfunctionMar 14, 2024Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED AN ISSUE REGARDING THE USE OF THE SAFETY NEEDLE AND STATED "AMPULE BAGS/PFS/VIAL LEAKS." THE PRODUCT INFORMATION WAS NOT PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18909079 ↗MalfunctionMar 13, 2024Crack; Crack
THE CUSTOMER REPORTED THAT THE TOP OF THE BLUE NEEDLE HUB WAS CRACKED ALL THE WAY DOWN TO THE NEEDLE. THERE WERE NO ADDITIONAL DETAILS GIVEN OTHER THAN THERE WERE NO INJURIES TO THE TEAM MEMBER OR PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18895565 ↗MalfunctionMar 13, 2024Crack; Crack
THE CUSTOMER REPORTED THAT THE MEDICAL ASSISTANT (MA) PUT A 23G 1-INCH NEEDLE WITH BLUE BASE ON A COVID 12+ VACCINE SYRINGE. THE NEEDLE WAS SECURELY ON THE SYRINGE. AS THE MA WAS PUSHING THE PLUNGER TO INJECT, THE MA SAW THAT THE VACCINE CAME OUT OF THE NECK OF THE VIAL/BASE OF THE NEEDLE AND NOT INTO THE PATIENT. AFTER INSPECTING THE VIAL AND NEEDLE, THE MA SAW THAT THE BASE OF THE NEEDLE WAS CHIPPED. THE PROVIDER AND THE PATIENT WERE NOTIFIED. THE DOCTOR SAID THAT WE COULD RE-VACCINATE IF THEY WANT. THE PATIENT SAID THEY WILL NEXT TIME THEY ARE IN CLINIC. THE NEEDLE WAS INSPECTED PRIOR TO DISCARDING IT IN THE SHARPS CONTAINER. IT WAS REPORTED THAT THE BLUE NEEDLE HUB CRACKED OFF IN THE TWIST ON. NO INJURY OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18895562 ↗MalfunctionAug 10, 2023Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED SMALL SPILLAGE FROM STEM OF NEEDLE, AS SUCH FULL DOSE NOT ADMINISTRATED. HOWEVER, NEEDLE WAS TIGHTLY SCREWED ON.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17505163 ↗MalfunctionNov 7, 2022Air/Gas in Device; Air/Gas in Device
CUSTOMER REPORTS: AIR BUBBLES ARE FORMING IN THE NEEDLES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15743576 ↗MalfunctionSep 9, 2021Fluid/Blood Leak; Fluid/Blood Leak
CUSTOMER REPORTS: THE CANNULA LEAKS AND LIQUID LEAKED OUT OF THE SIDE OF THE PLASTIC ATTACHMENT WHEN INJECTING.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 12448055 ↗
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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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