Magellan 8881850510Recalls & reported problems

Summary

The FDA's MAUDE database contains 118 adverse event reports that list this exact device (DI 10884521000568), received between Jun 23, 2017 and Sep 9, 2026 — classified as 4 injuries, 114 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (49 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 118 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 9, 2026Fail-Safe Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50697084 ↗
• MalfunctionDec 26, 2025Fail-Safe Problem; Fail-Safe Problem

  THE CUSTOMER REPORTED THAT THEY HAVE BEEN EXPERIENCING SAFETY CONCERNS AND ALSO A NEEDLE STICK WITH THE CARDINAL MAGELLAN HYPODERMIC SAFETY NEEDLE 25G X 1¿, 8881850510, LOT 25G254. THIS NEEDLE IS BEING USED AS A SUB FOR THE BACKORDERED BD NEEDLE 305916. THE PRACTICE HAS NOTED THE PRODUCT HAS A DEFECTIVE SAFETY LOCK ON THE NEEDLES AND HAVE EXPERIENCED ON MULTIPLE DIFFERENT USES THAT WHEN CLOSING THE SAFETY MECHANISM, THE NEEDLE HAS REMAINED OUT. THE NEEDLE WILL ALSO BEND FORWARD AND MISS THE SAFETY LOCK ALL TOGETHER, OVERALL, THEY ARE FLIMSY AND POOR QUALITY. THESE NEEDLES ARE BEING USED FOR IM INJECTIONS.

  Patient problems: Needle Stick/Puncture

  MAUDE report 23896061 ↗
• MalfunctionNov 24, 2025Fail-Safe Problem; Fail-Safe Problem

  THE CUSTOMER REPORTED THAT AFTER GIVING MULTIPLE INJECTIONS TO A PATIENT, SHE ENGAGED THE SAFETY DEVICES. WHEN SHE WAS PLACING THEM IN THE SHARPS CONTAINER, SHE WAS POKED BY ONE OF THE NEEDLES THAT THE SAFETY DEVICE DID NOT FULLY ENGAGE. ADDITIONAL INFORMATION PROVIDED ON 24NOV2025 STATED THAT THE EMPLOYEE REQUIRED LAB WORK TO BE COMPLETED, BUT NO OTHER KNOWN TREATMENTS HAVE BEEN PROVIDED AT THIS TIME.

  Patient problems: Needle Stick/Puncture

  MAUDE report 23638933 ↗
• MalfunctionNov 24, 2025Fail-Safe Problem; Fail-Safe Problem

  THE CUSTOMER REPORTED THAT AFTER ADMINISTERING AN INJECTION TO A PATIENT, THE EMPLOYEE ENGAGED THE SAFETY DEVICE ON THE NEEDLE. THE SAFETY MECHANISM RELEASED UNEXPECTEDLY. WHEN THE EMPLOYEE RE-ENGAGED THE SAFETY DEVICE, THE NEEDLE BENT. EMPLOYEE WAS UNAWARE THE NEEDLE WAS BENT AND POKE HERSELF WHILE DISPOSING THE NEEDLE IN SHARPS CONTAINER. ADDITIONAL INFORMATION PROVIDED ON 24NOV2025 STATED THAT THE EMPLOYEE REQUIRED LAB WORK TO BE COMPLETED, BUT NO OTHER KNOWN TREATMENTS HAVE BEEN PROVIDED AT THIS TIME.

  Patient problems: Needle Stick/Puncture

  MAUDE report 23638932 ↗
• MalfunctionJan 8, 2025Fail-Safe Problem; Fail-Safe Problem

  THE CUSTOMER REPORTED THAT AFTER ADMINISTERING A VACCINE, THE SAFETY MECHANISM MALFUNCTIONED AND NEEDLE BENT SLIGHTLY. WHILE TRYING TO USE SAFETY NEEDLE MECHANISM, DEVICE WAS PRESSED GENTLY ON A FLAT SURFACE. DEVICE DID NOT CLOSE CORRECTLY, CAUSING NEEDLE TO PROTRUDE OUTWARD WITHOUT POINT COVERED. MECHANISM DID FULLY EXTEND TO LOCKED POSITION BUT DID NOT STAY IN PLACE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21107418 ↗
• MalfunctionJan 7, 2025Fail-Safe Problem; Fail-Safe Problem

  THE CUSTOMER REPORTED THAT THE SAFETY DEVICE DID NOT CLOSE PROPERLY EXPOSING THE NEEDLE. THIS OCCURRED DURING VACCINE ADMINISTRATION. ADDITIONAL INFORMATION RECEIVED ON 07JAN2025 STATED THAT NO ONE WAS INJURED BY THE DEVICE, NO MEDICAL INTERVENTION REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21094124 ↗
• MalfunctionJan 3, 2025Fail-Safe Problem; Fail-Safe Problem

  THE CUSTOMER REPORTED THAT THEY HAD MULTIPLE REPORTS FROM ONE DEPARTMENT OF AN ISSUE WITH THE MAGELLAN SAFETY NEEDLE. IT WAS REPORTED THAT THE NEEDLE WAS PROTRUDING FROM SAFETY PLASTIC. ADDITIONALLY, IT WAS REPORTED THAT THERE IS A HOLE THAT THE NEEDLE COMES THROUGH ON THE TOP. THEY DO NOT FEEL IT IS THE TECHNIQUE OF THE NURSE YET MORE A SAFETY CONCERN DUE TO HOW THIS PRODUCT IS MADE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21070612 ↗
• MalfunctionDec 4, 2024Fail-Safe Problem; Fail-Safe Problem

  THE CUSTOMER STATED THE NEEDLES WERE BENDING VERY EASILY AND WON'T ALLOW THE SAFETY GLIDE TO ENGAGE. ADDITIONAL INFORMATION RECEIVED ON 03DEC2024 STATED THAT THE NEEDLE IS BENDING WHEN THE SAFETY MECHANISM IS BEING USED. THE NEEDLE WAS ALSO BENDING WHEN IT WAS PUT INTO A VIAL TO DRAW UP A MEDICATION/IMMUNIZATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20848521 ↗
• MalfunctionNov 19, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT THE NEEDLE WAS SECURELY ATTACHED TO THE SYRINGE, WHEN INJECTED THE MEDICATION DIDN'T GO THROUGH THE NEEDLE AND LEAK OUT WHERE THE SYRINGE ATTACHES TO THE NEEDLE. FATHER WAS AWARE, EVEN STATES "YES, I COULD FEEL HIS LEG IS WET." PROVIDER NOTIFIED AND DOSE REPEATED WITH FATHER'S CONSENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20725775 ↗
• MalfunctionNov 8, 2024Crack; Crack

  THE CUSTOMER REPORTED THAT THE ORANGE PIECE OF THE NEEDLE WAS CRACKED UPON OPENING NEEDING. NO OTHER DAMAGE REPORTED TO THE BOX.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20641655 ↗
• MalfunctionNov 1, 2024Fail-Safe Problem; Fail-Safe Problem

  THE CUSTOMER REPORTED THAT THE SAFETY DEVICE DID NOT ENGAGE WHEN THE USER ATTEMPTED TO ENGAGE IT. WHEN ENGAGEMENT WAS MANUALLY FORCED, THE NEEDLE BENT. THE NEEDLE APPEARS TO BE TOO LONG FOR THE SAFETY DEVICE TO FIT OVER IT, WHICH CAUSED THE NEEDLE TO BEND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20588029 ↗
• MalfunctionOct 24, 2024Fail-Safe Problem; Fail-Safe Problem

  THE CUSTOMER REPORTED THAT THE NEEDLE BENT WHEN USED FOR THE FLU SHOT. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2024 CLARIFIED THAT THE NEEDLE BENT AFTER AN ATTEMPT TO ACTIVATE THE SAFETY FEATURE AFTER THE SHOT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20527120 ↗
• MalfunctionOct 22, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT A NURSE WAS ADMINISTERING EMPLOYEE FLU SHOTS. A NEEDLE WAS OPENED AND CORRECTLY SCREWED ON TO FLU SYRINGE. WHEN THE NEEDLE TIP WAS ENTERED IN TO ARM, THE FLU VACCINE LEAKED AROUND THE PLASTIC TIP AT THE NEEDLE BASE. THE NEEDLE ITSELF DID NOT BREAK, ONLY THE PLASTIC LEAKED. ADDITIONAL INFORMATION RECEIVED ON 18OCT2024 STATED THAT THEY GAVE THE EMPLOYEE ANOTHER VACCINE AS THEY FELT THAT NONE OF IT FLOWED INTO THE EMPLOYEE¿S ARM. A NEW SYRINGE AND NEEDLE WAS USED WHEN IT WAS ADMINISTERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20502183 ↗
• MalfunctionOct 21, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THEIR FLU CLINIC ENCOUNTERED SOME ISSUES YESTERDAY WITH THE 25GX1IN SAFETY NEEDLE, 8881850510. THEY WERE RANDOMLY LEAKING DURING ADMINISTRATION. STAFF MADE SURE THE NEEDLE AND SYRINGE WERE TIGHT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20499600 ↗
• MalfunctionJul 10, 2024Fail-Safe Did Not Operate; Fail-Safe Did Not Operate

  THE CUSTOMER REPORTED THAT A FEW WORK CENTERS ARE HAVING ISSUES OF THE SAFETY NOT ENGAGING ON THE NEEDLE CAUSING A ¿STICK INSTANCE¿. ON (B)(6) 2024 THE CUSTOMER CONFIRMED THAT NO ONE WAS STUCK BY THE NEEDLE, BUT THE ISSUE PRODUCED THE POSSIBILITY FOR A ¿STICK INSTANCE¿.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19710628 ↗
• MalfunctionJun 27, 2024Fail-Safe Did Not Operate; Fail-Safe Did Not Operate

  THE CUSTOMER REPORTED THAT A FEW WORK CENTERS ARE HAVING ISSUES OF THE SAFETY NOT ENGAGING ON THE NEEDLE CAUSING A ¿STICK INSTANCE¿. ON 25JUN2024 THE CUSTOMER CONFIRMED THAT NO ONE WAS STUCK BY THE NEEDLE, BUT THE ISSUE PRODUCED THE POSSIBILITY FOR A ¿STICK INSTANCE¿.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19629566 ↗
• MalfunctionApr 25, 2024Fail-Safe Did Not Operate; Fail-Safe Did Not Operate

  THE CUSTOMER REPORTED THAT THE SAFETY NEEDLE MECHANISM DID NOT WORK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19182012 ↗
• MalfunctionMar 29, 2024Fluid/Blood Leak; Fluid/Blood Leak

  CUSTOMER REPORTS: THE PRODUCT IS LEAKING FLUID OUT OF THE NEEDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19005061 ↗
• MalfunctionMar 28, 2024Fluid/Blood Leak; Fluid/Blood Leak

  CUSTOMER REPORTS: THE PRODUCT IS LEAKING FLUID OUT OF THE NEEDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18996541 ↗
• MalfunctionMar 28, 2024Fluid/Blood Leak; Fluid/Blood Leak

  CUSTOMER REPORTS: THE PRODUCT IS LEAKING FLUID OUT OF THE NEEDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18995245 ↗
• MalfunctionMar 12, 2024Fail-Safe Problem; Fail-Safe Problem

  THE CUSTOMER REPORTED THAT A NURSE WAS GIVING A PATIENT A VACCINATION USING THE MAGELLAN 25 GAUGE 1 INCH NEEDLE AND AFTER COMPLETING THE VACCINATION, THE NURSE PUSHED THE SAFETY DEVICE UP AND IT MALFUNCTION AND DID NOT LOCK AND THE NEEDLE CAME THROUGH THE PLASTIC SAFETY DEVICE. THE ITEM WAS ORIGINALLY REPORTED AS 5551850510 LOT 223E107 BUT WAS UPDATED TO 8881850510 LOT 23E107 AFTER CONFIRMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18887592 ↗
• MalfunctionJan 3, 2024Crack; Leak/Splash; Crack; Leak/Splash

  THE CUSTOMER REPORTED THAT SHE WAS GETTING A FLU VACCINE READY FOR ADMINISTRATION. AS SHE WAS ATTACHING THE NEEDLE THERE WAS A CLICKING SOUND WHICH AT THE TIME, SHE THOUGHT NOTHING OF, AS THE NEEDLE SHE HAD ATTACHED ARE NOT THE ONES THEY NORMALLY HAVE ORDERED TO THEIR OFFICE, AND SO SHE THOUGHT IT WAS JUST THE NEEDLE CLICKING INTO PLACE. SHE BELIEVED THAT WAS THE MOMENT THAT THE HUB OF THE NEEDLE SHE WAS USING CRACKED. AS SHE WAS UNAWARE OF THE CRACK AND DID NOT SEE ANY DEFORMITIES OR ISSUES WITH ANY PART OF THE NEEDLE, SHE WENT ALONG WITH ADMINISTERING THE FLU SHOT TO THE PATIENT. UPON PUSHING THE PLUNGER TO DELIVER THE FLU SHOT, THE FLUID, INSTEAD OF GOING THROUGH THE NEEDLE, CAME THROUGH THE CRACK IN THE HUB OF THE NEEDLE. SHE GAVE THE PATIENT SOME PAPER TOWELS, AS HE NOW HAD MOST IF NOT ALL OF A FLUBLOK VACCINE DRIPPING DOWN HIS LEFT UPPER ARM. MD AWARE AND INSTRUCTED HER, SO LONG AS THE PATIENT WAS OKAY WITH IT, TO GIVE THE FLU SHOT AGAIN AS IT WAS UNLIKELY, HE GOT ANY OF THE PREVIOUS ONE. THE PATIENT GOT THE NEW FLU SHOT READY, USING THE NEEDLES THEY REGULARLY HAVE ORDERED TO THE OFFICE AND ADMINISTERED AS USUAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18434886 ↗
• MalfunctionDec 20, 2023Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT FLU VACCINE LEAKED WHILE PATIENT WAS GETTING FLU SHOT. THE MA NOTICED THE VACCINE WAS LEAKING ON THE PATIENT'S LEFT ARM AND FLOOR WHILE PLACING PRESSURE ON THE PLUNGER. THE LVN CONFIRMED MALFUNCTION OF NEEDLE AND OBSERVED REMAINING MEDICATION LEAKING FROM HUB AND NOT COMING OUT OF NEEDLE. NO MEDICATION WAS ADMINISTERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18369488 ↗
• MalfunctionNov 28, 2023Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  CUSTOMER REPORT AN ISSUE WITH A COVIDIEN-MAGELLAN SAFETY NEEDLE. A CHILD WAS RECEIVING VACCINES THIS WEEK. THE SITE CLEANED AND PREPPED, INSERTED NEEDLE INTO MUSCLE WITHOUT A PROBLEM. WHEN BEGINNING TO INJECT THE SOLUTION, IT SHOT OUT OF THE HUB OF THE NEEDLE INTO THE MOTHER'S RIGHT EYE. THE SYRINGE WAS 1ML BD LUER-LOCK. NEEDLE WAS MAGELLAN 25G 1" COVIDIEN SAFETY NEEDLE. ADDITIONAL INFORMATION STATED THAT EYEWASH WAS PERFORMED WITH NO FURTHER INTERVENTION NEEDED FOR THE FLUID THAT SPLASHED IN THE MOTHER'S EYE. THE HUB WAS VISIBLY CRACKED.

  Patient problems: Foreign Body Sensation in Eye

  MAUDE report 18222612 ↗
• MalfunctionNov 3, 2023Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  THE CUSTOMER SENT TWO PHOTOS, ONE THAT APPEARS TO SHOW A BENT NEEDLE COMING OUT UNDER THE SHEATH AND ANOTHER PHOTO THAT APPEARS TO SHOW A SMALL AMOUNT OF BLOOD ON A THUMB. THEY STATED THAT THEY HAVE HAD NUMEROUS OCCASIONS LIKE THIS AND THAT THEY WOULD LIKE TO BE ABLE TO GO BACK TO THE OLD NEEDLES THEY USED SO THEY CAN CUT DOWN ON NEEDLE STICKS. THEY USED TO USE BD ECLIPSE NEEDLES AND DID NOT HAVE THIS ISSUE. ADDITIONAL INFORMATION RECEIVED ON 20OCT2023 STATED THAT THERE HAVE BEEN MULTIPLE TIMES WHERE THE NEEDLES JUST BEND AND BREAK WHEN TRYING TO DRAW UP MEDS. ONE PERSON HAS BEEN STUCK (PRE PATIENT) 3-4 TIMES. THE NEEDLES ALSO DO NOT ALWAYS LATCH TO THE SYRINGE AND AS THEY ARE INJECTING THE PATIENT, AND THEY CAN SEE THE MEDICATION DRIPPING OUT FROM THAT POINT, SO THE PATIENT IS NOT GETTING THE FULL DOSE. THE DOCTOR USES THESE FOR STEROID INJECTIONS AND IS WORRIED ABOUT HOW EASILY THEY BEND WHEN HE IS DOING JOINT INJECTIONS. SOME NEEDLES ARE JUST POINTING DIRECTLY SIDEWAYS WHEN THEY ARE FIRST OPENED.

  Patient problems: Needle Stick/Puncture

  MAUDE report 18070155 ↗