Magellan 8881850558Recalls & reported problems

Summary

The FDA's MAUDE database contains 87 adverse event reports that list this exact device (DI 10884521000575), received between Nov 8, 2016 and Dec 23, 2025 — classified as 6 injuries, 81 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (51 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 87 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 09DEC2025 STATED THAT ONE MA WAS STUCK WITH A NEEDLE WHILE GIVING A VACCINE. IT IS UNKNOWN IF ANY INTERVENTION OR TESTING WAS REQUIRED.

  Patient problems: Needle Stick/Puncture

  MAUDE report 23882466 ↗
• MalfunctionDec 10, 2025Fail-Safe Problem; Fail-Safe Problem

  THE CUSTOMER REPORTED THAT THE NEW NEEDLE REPLACEMENT FOR BACK ORDERED 25G 5/8 BRANDED MAGELLAN LOT 23K131 WAS VERY DIFFICULT TO UNCAP. PRIOR NEEDLE OF SAME LOT UNCAPPED BUT SHEATHED ITSELF WITH CAP REMOVAL PRIOR TO INJECTION TO PATIENT. STAFF USED SIGNIFICANT FORCE TO REMOVE CAP AND IN PROCESS STABBED LEFT THUMB OF STAFF. BLEEDING IN GLOVE, NO HARM TO PATIENT. NEEDLE REPLACED AND INJECTION GIVEN TO PATIENT. ADDITIONAL INFORMATION RECEIVED ON 27NOV2025 STATED THAT THE STAFF MEMBER RECEIVED FIRST-AID (I.E., SELF-CARE, PRESSURE TO WOUND, CLEANED AND BAND-AID). THERE WAS NO BLOOD DRAW OR PROPHYLACTIC MEDICATION SINCE THE INCIDENT OCCURRED PRIOR TO PATIENT.

  Patient problems: Needle Stick/Puncture

  MAUDE report 23771273 ↗
• MalfunctionJan 8, 2025Fail-Safe Problem; Fail-Safe Problem

  THE CUSTOMER REPORTED THAT DURING VACCINE CLINIC MAGELLAN NEEDLES WERE BEING USED. THERE WERE SEVERAL OCCURRENCES WHERE THE MAGELLAN SAFETY NEEDLE WAS PUT IN THE LOCKED POSITION BUT THE COVER DID NOT COMPLETELY COVER THE NEEDLE TIP RESULTING IN SEVERAL NEAR MISSES OF POSSIBLE NEEDLE POKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21107404 ↗
• MalfunctionJan 7, 2025Fail-Safe Problem; Fail-Safe Problem

  THE CUSTOMER REPORTED THAT THE NEEDLE MALFUNCTIONED WHILE ACTIVATING THE SAFETY RESULTING IN A NEEDLE STICK. THE NEEDLE WAS USED TO DRAW UP LIDOCAINE AND OFF OF THE SYRINGE WHEN THE POKE HAPPENED. THIS COULD CAUSE A PROBLEM IF IT WAS A NEEDLE USED IN A PATIENT OR IF THE NEEDLE WAS TO BEND IN THE PATIENT, SO THEY REPORTED IT AS A POTENTIAL PATIENT SAFETY EVENT. ADDITIONAL INFORMATION RECEIVED ON 07JAN2025 STATED THAT THERE WAS NOT MEDICAL TREATMENT REQUIRED, JUST THE REQUIRED TESTING.

  Patient problems: Needle Stick/Puncture

  MAUDE report 21094430 ↗
• MalfunctionNov 12, 2024Fail-Safe Problem; Fail-Safe Problem

  THE CUSTOMER REPORTED THAT THE NEEDLE HAD TROUBLE LOCKING AND THEY HAD TO PRESS HARDER THAN NORMAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20668004 ↗
• MalfunctionApr 23, 2024Fail-Safe Problem; Fail-Safe Problem

  THE CUSTOMER REPORTED THEY ARE HAVING AN ISSUE WITH SOME OF THE SAFETY NEEDLE. THEY STATED THAT IT IS NOT EVERY ONE BUT IT IS HAPPENING ON A REGULAR BASIS. THE CUSTOMER STATED THERE HAS BEEN NO IMPACT OR INJURIES AT THIS TIME. ADDITIONAL INFORMATION PROVIDED ON (B)(6) 2024 STATED THAT THE ISSUE IS THAT WHEN PLACING THE SAFETY MECHANISM OVER THE TOP OF THE NEEDLE, THE NEEDLE IS NOT COMPLETELY COVERED. THE SHARP END OF THE NEEDLE IS STILL OUT PAST THE COVER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19168587 ↗
• MalfunctionMar 13, 2024Crack; Crack

  THE CUSTOMER REPORTED THAT THE MEDICAL ASSISTANT ATTACHED THIS NEEDLE TO A PRE-FILLED SYRINGE (VACCINE). WHEN ATTEMPTING TO ADMINISTER, THE VACCINE SPILLED OUT OF THE HUB. SHE INSPECTED THE SYRINGE/NEEDLE AND NOTICED THAT THE HUB ON THE NEEDLE WAS CRACKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18897206 ↗
• MalfunctionMar 12, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT THE ITEM HAS BEEN LEAKING. THEY STATED THAT THIS IS NOT A VISUAL DEFECT. THE LEAK APPEARS TO COME FROM THE COLORED HUB ONCE THE PLUNGER ON THE SYRINGE IS PUSHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18890685 ↗
• MalfunctionJan 30, 2024Fail-Safe Problem; Fail-Safe Problem

  THE CUSTOMER REPORTED THAT THE NEEDLE BENT SLIGHTLY (FROM PRESSURE ENGAGING THE COVER) AND PROTECTOR WAS ENGAGED. IT SEEMS LIKE THE INTERNAL CLIP DIDN¿T ACTIVATE BECAUSE THE NEEDLE WAS BENT MEANING THE NEEDLE COULD BE EXPOSED AGAIN. NO INJURY REPORTED DURING THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18606831 ↗
• MalfunctionJan 30, 2024Fail-Safe Problem; Fail-Safe Problem

  THE CUSTOMER REPORTED THAT THE NEEDLE BENT SLIGHTLY (FROM PRESSURE ENGAGING THE COVER) AND PROTECTOR WAS ENGAGED. IT SEEMS LIKE THE INTERNAL CLIP DIDN¿T ACTIVATE BECAUSE THE NEEDLE WAS BENT MEANING THE NEEDLE COULD BE EXPOSED AGAIN. THIS INCIDENT RESULTED IN A NEEDLE STICK INJURY. THE RN WENT TO OCCUPATIONAL HEALTH FOR THE NEEDLE STICK INJURY. ADDITIONAL INFORMATION RECEIVED ON 24JAN2024 STATED THAT THEY COULD NOT PROVIDE SPECIFIC INFORMATION REGARDING THE TREATMENT BUT CONFIRMED THAT THEY ARE ACTING IN ACCORDANCE WITH ONTARIO'S MANDATORY BLOOD TESTING ACT (2006).

  Patient problems: Needle Stick/Puncture

  MAUDE report 18606830 ↗
• MalfunctionJan 12, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT WHILE INJECTING SUBCUTANEOUS AZACYTIDINE, NURSE NOTED LEAKING AROUND THE NEEDLE. THE ITEM WAS A MONOJECT MAGELLAN HYPODERMIC SAFETY NEEDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18503252 ↗
• MalfunctionNov 27, 2023Fail-Safe Problem; Fail-Safe Problem

  THE CUSTOMER REPORTED THAT THEY HAD A NEEDLESTICK ACCIDENT DUE TO THE SAFETY NEEDLE NOT LOCKING PROPERLY. THE NEEDLE LOCK DEVICE FAILED, AND RETRACTED WHEN THEY PLACED THE SYRINGE IN THE SHARPS CONTAINER. THEY THEN POKED THEIR LEFT INDEX FINGER. THE NEEDLE HAD BEEN USED ON A PATIENT. THEY TRIED IT AGAIN ON ANOTHER NEEDLE AND THE SECURITY DEVICE FAILED TO ENGAGE. THEY WERE TREATED IN THE ER AND WILL FOLLOW UP WITH EMPLOYEE HEALTH SERVICES. ADDITIONAL INFORMATION RECEIVED ON 02-NOV2023 CONFIRMED THAT THE SECOND NEEDLE WAS A CLEAN NEEDLE. INFORMATION REGARDING IF TREATMENT WAS REQUIRED IS PENDING.

  Patient problems: Needle Stick/Puncture

  MAUDE report 18212620 ↗
• MalfunctionNov 13, 2023Fail-Safe Problem; Fail-Safe Problem

  THE CUSTOMER REPORTED THAT THE NURSE HAD A SAFETY NEEDLE THAT DID NOT LOCK PROPERLY. THE NEEDLE WAS USED ON A PATIENT HOWEVER NO INJURIES OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18127505 ↗
• MalfunctionJul 11, 2023Use of Device Problem; Fail-Safe Did Not Operate; Use of Device Problem; Fail-Safe Did Not Operate

  CUSTOMER REPORTS: WHEN ATTEMPTING TO ADMINISTER A SHOT TO A 4-YEAR-OLD, THE STAFF MEMBER WAS STABBED. THE SAFETY MECHANISM DOES NOT ALWAYS WORK AND COVER THE TOP OF THE NEEDLE. THE STAFF MEMBER WAS CHECKED BY EMPLOYEE HEALTH. THE CUSTOMER REQUESTED STAFF EDUCATION AS PRODUCT IS NEEDED AT THE FACILITIES.

  Patient problems: Needle Stick/Puncture

  MAUDE report 17303170 ↗
• MalfunctionMay 5, 2023Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THERE WAS A LEAK AT THE CONNECTION POINT BETWEEN THE CARDINAL HEALTH HYPODERMIC SAFETY NEEDLE AND THE BD PHASEAL OPTIMA INJECTOR. IN ADDITION TO THE NEEDLE AND INJECTOR, A BD PHASEAL OPTIMA CONNECTOR WAS ALSO BEING USED AT THE TIME. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16876685 ↗
• MalfunctionMay 5, 2023Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THERE WAS A LEAK AT THE CONNECTION POINT BETWEEN THE CARDINAL HEALTH HYPODERMIC SAFETY NEEDLE AND THE BD PHASEAL OPTIMA INJECTOR. IN ADDITION TO THE NEEDLE AND INJECTOR, A BD PHASEAL OPTIMA CONNECTOR WAS ALSO BEING USED AT THE TIME. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16876668 ↗
• MalfunctionMar 13, 2023Fail-Safe Did Not Operate; Fail-Safe Did Not Operate

  CUSTOMER REPORTS: THIS IS A SAFETY COMPLAINT. A NEEDLESTICK INJURY OCCURRED WITH A STAFF MEMBER DURING PATIENT USE. THE RN ADMINISTERED AN INJECTION; WHEN ATTEMPTING TO ACTIVATE THE PROTECTIVE COVER OVER THE NEEDLE, THE COVER WOULD ONLY ADVANCE HALFWAY AND WAS STUCK LEAVING THE NEEDLE EXPOSED LEADING TO A NEEDLESTICK INJURY TO STAFF. BLOODWORK WAS DONE TO MONITOR THE STAFF MEMBER AS MEDICAL INTERVENTION.

  Patient problems: Exposure to Body Fluids; Needle Stick/Puncture

  MAUDE report 16529891 ↗
• MalfunctionFeb 13, 2023Fail-Safe Problem; Fail-Safe Problem

  CUSTOMER REPORTS: WHEN THE THE SAFETY WAS ENGAGED ON THE NEEDLE, THE NEEDLE REMAINED EXPOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16362443 ↗
• MalfunctionJan 20, 2023Fluid/Blood Leak; Fluid/Blood Leak

  CUSTOMER REPORTS: THE NURSE HAD TO STOP TREATMENT DUE TO THE NEEDLE LEAKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16218744 ↗
• MalfunctionJan 20, 2023Fluid/Blood Leak; Fluid/Blood Leak

  CUSTOMER REPORTS: ONE OF THE NURSING STAFF REPORTED LEAKING ISSUES WITH A HYPODERMIC SAFETY NEEDLE 25G 5/8¿ LAST WEEK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16217916 ↗
• MalfunctionDec 9, 2022Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT IT APPEARS THAT THERE WAS LEAKAGE HAPPENING AT THE POINT OF THE ORANGE PLASTIC ON THE NEEDLE AND THE STEEL NEEDLE. THIS INCIDENT INVOLVED HAZARDOUS CYTOTOXIC MEDICATION. THE NEEDLE WAS CHANGED WHICH RESULTED IN OPENING A CLOSED SYSTEM AND EXPOSURE OF SUBSTANCE TO NURSING TEAM. NO HARM TO PATIENT. APPROPRIATE SPILL CLEAN UP WAS COMPLETED. MEDICATION DELIVERED TO PATIENT WITH NEW NEEDLE CONNECTED. PHOTOS ATTACHED. ADDITIONAL INFORMATION RECEIVED ON 29NOV2022 STATED THAT THE MEDICATION WAS RITUXIMAB. THE NURSES WERE EXPOSED TO THE DRUG AS A RESULT OF THE LEAKING DEVICE. THEY WERE WEARING APPROPRIATE PPE SO EXPOSURE WAS A NON-EVENT. THIS OCCURRED WHEN ATTEMPTING TO ADMINISTER MEDICATION TO PATIENT. THE NEEDLE WAS REPLACED AND MEDICATION ADMINISTERED. NO PATIENT INJURY AND MEDICAL INVENTION WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15954394 ↗
• 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 15744165 ↗
• MalfunctionOct 6, 2022Use of Device Problem; Fail-Safe Did Not Operate; Use of Device Problem; Fail-Safe Did Not Operate

  CUSTOMER REPORTS: THE NEEDLE DIDN¿T ACTIVATE THE SAFETY NEEDLE FEATURE AND POKED THE NURSE. PER ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER, THE NEEDLE STICK OCCURRED WITH A USED NEEDLE AND PROTOCOL FOR EMPLOYEE HEALTH WAS CONDUCTED. THERE IS NO ADDITIONAL TESTING OR PROCEDURE REQUIRED THAT WE HAVE BEEN MADE AWARE OF.

  Patient problems: Exposure to Body Fluids; Needle Stick/Puncture

  MAUDE report 15552556 ↗
• MalfunctionSep 7, 2022Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT AN INCIDENT OCCURRED AT THE ORANGE PLASTIC SAFETY LATCH CONNECTION POINT WITH THE NEEDLE, CAUSING MEDICATION TO LEAK FROM THAT POINT. THE INCIDENT WAS CAUGHT IN TIME AND THE NEEDLE WAS CHANGED, WHICH RESULTED IN OPENING A CLOSED SYSTEM. THERE WAS NO PATIENT HARM. THE APPROPRIATE SPILL CLEAN UP WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15373961 ↗
• MalfunctionSep 7, 2022Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT AN INCIDENT OCCURRED AT THE ORANGE PLASTIC SAFETY LATCH CONNECTION POINT WITH THE NEEDLE, CAUSING MEDICATION TO LEAK FROM THAT POINT. THE INCIDENT WAS CAUGHT IN TIME AND THE NEEDLE WAS CHANGED, WHICH RESULTED IN OPENING A CLOSED SYSTEM. THERE WAS NO PATIENT HARM. THE APPROPRIATE SPILL CLEAN UP WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15373951 ↗