MagellanRecalls & reported problems across all models
Cardinal Health, Inc. · 29 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 445
- Deaths reported
- 0
- Injuries reported
- 30
- Recalls
- 0
We found 29 models of Magellan by Cardinal Health, Inc. in the FDA's device registry (GUDID). Together they are named in 445 adverse event reports in the FDA's MAUDE database, received between Nov 8, 2016 and Sep 15, 2026 — classified as 30 injuries, 415 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (188 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Magellan problems
Device problems
- Fluid/Blood Leak188
- Fail-Safe Problem87
- Break56
- Crack42
- Fail-Safe Did Not Operate31
- Device Contaminated During Manufacture or Shipping29
- Device Contamination with Chemical or Other Material16
- Detachment of Device or Device Component13
Patient problems
- No Clinical Signs, Symptoms or Conditions183
- No Consequences Or Impact To Patient99
- Needle Stick/Puncture60
- No Patient Involvement54
- No Known Impact Or Consequence To Patient30
- Insufficient Information13
- No Information7
- Exposure to Body Fluids3
Magellan models
29 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Magellan 8881850510Needle, hypodermic, single lumen118 reports
- Magellan 8881850558Needle, hypodermic, single lumen87 reports
- Magellan 8881850310Needle, hypodermic, single lumen43 reports
- Magellan 8881850215Needle, hypodermic, single lumen41 reports
- Magellan 8881833510Needle, hypodermic, single lumen19 reports
- Magellan 8881833558Needle, hypodermic, single lumen16 reports
- Magellan 8881833310Needle, hypodermic, single lumen14 reports
- Magellan 8881850815Needle, hypodermic, single lumen13 reports
- Magellan 8881892910Syringe, Piston12 reports
- Magellan 8881892950Syringe, piston12 reports
- Magellan 8881850515Needle, hypodermic, single lumen12 reports
- Magellan 8881833215Needle, hypodermic, single lumen9 reports
- Magellan 7777850310Needle, hypodermic, single lumen7 reports
- Magellan 8881850110Needle, hypodermic, single lumen6 reports
- Magellan 8881882812Syringe, piston6 reports
- Magellan 8881882712Syringe, piston5 reports
- Magellan 8881850115Needle, hypodermic, single lumen3 reports
- Magellan 8881850015Needle, hypodermic, single lumen3 reports
- Magellan 8881850810Needle, hypodermic, single lumen3 reports
- Magellan 8881850210Needle, hypodermic, single lumen2 reports
- Magellan 8881850915Needle, hypodermic, single lumen2 reports
- Magellan 8881811510Needle, hypodermic, single lumen2 reports
- Magellan 8881893010Syringe, piston2 reports
- Magellan 8881850058Needle, hypodermic, single lumen2 reports
- Magellan 7777866210Needle, hypodermic, single lumen2 reports
- Magellan 8881850010Needle, hypodermic, single lumen1 report
- Magellan 8881850158Needle, hypodermic, single lumen1 report
- Magellan 8881833115Needle, hypodermic, single lumen1 report
- Magellan 8881892930Syringe, piston1 report
Recent Magellan adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 15, 2026Fail-Safe Did Not Operate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50779402 ↗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 ↗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 ↗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 ↗MalfunctionNov 25, 2025Fail-Safe Problem; Fail-Safe Problem
THE CUSTOMER REPORTED THAT THE RN STATED THEY WERE PUSHING THE SAFETY OF THE INSULIN SYRINGE AND IT WENT TO THE SIDE, ACCIDENTLY POKING PINKY FINGER. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: Needle Stick/Puncture
MAUDE report 23647124 ↗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 ↗MalfunctionOct 15, 2025Fail-Safe Problem; Fail-Safe Problem
THE CUSTOMER REPORTED THAT THE NURSE WAS HANDLING A MAGELLAN HYPODERMIC SAFETY NEEDLE ATTACHED WITH THE GUARD DEPLOYED, WRITER EXPERIENCED A NEEDLE STICK TO THE LEFT THUMB IN SPITE OF THE SAFETY GUARD BEING DEPLOYED. ADDITIONAL INFORMATION RECEIVED ON 14OCT2025 STATED THAT THE NURSE RECEIVED FIRST AID AND WAS MANAGED BY OCC HEALTH. INFORMATION FROM THE EMPLOYEE RECORDS IS NOT AVAILABLE.
Patient problems: Needle Stick/Puncture
MAUDE report 23297155 ↗MalfunctionAug 7, 2025Fail-Safe Problem; Fail-Safe Problem
THE CUSTOMER REPORTED THAT THEY HAD AN ACCIDENTAL NEEDLESTICK INCIDENT INVOLVING SYRINGE MODEL 8881892950 DISPENSED BY PHARMACY FOR LONG-ACTING INSULIN ADMINISTRATION. THE CORE SAFETY CONCERN IS THAT THE NEEDLE GUARD ON THIS SYRINGE DOES NOT ENGAGE SMOOTHLY. INITIALLY, IT SLIDES UP AND APPEARS TO STOP, WHICH CAN GIVE THE IMPRESSION THAT THE NEEDLE IS FULLY COVERED. HOWEVER, NURSES NEED TO APPLY ADDITIONAL FORCE BEYOND THIS INITIAL RESISTANCE TO FULLY ACTIVATE THE SAFETY GUARD AND PROPERLY COVER THE NEEDLE. THIS INCOMPLETE CLOSURE CREATES A RISK FOR ACCIDENTAL NEEDLESTICKS. ADDITIONAL INFORMATION RECEIVED ON 23JUL2025 STATED THAT THERE WAS NO MEDICAL TREATMENT NEEDED DUE TO IT BEING A CLEAN NEEDLE STICK.
Patient problems: Needle Stick/Puncture
MAUDE report 22741860 ↗MalfunctionAug 6, 2025Fail-Safe Problem; Fail-Safe Problem
THE CUSTOMER REPORTED THAT THEY RECEIVED A REPORT OF A SAFETY GUARD BREAKING WHILE BEING USED ON A NURSING UNIT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22733723 ↗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 THAT THEY INJECTED DEPOT TO RIGHT VENTRO-GLUTEAL. NEEDLE APPEARED TO BE FAULTY AS SOME OF THE MEDICATION WAS LEAKING OUT FROM THE DEVICE BEFORE ENTERING THE LUMEN OF THE NEEDLE AS THE MEDICATION WAS BEING PUSHED THROUGH. THEY WERE UNABLE TO DETERMINE HOW MUCH DRUG WAS ACTUALLY RECEIVED BY PATIENT AND HOW MUCH HAD LEAKED OUT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21394102 ↗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 ↗
Other Cardinal Health, Inc. products
- Kangaroo145 models · 4,461 reports
- Monoject164 models · 701 reports · 7 recalls
- Dover90 models · 226 reports · 12 recalls
- Argyle64 models · 459 reports
- Salem Sump28 models · 92 reports · 3 recalls
- Vistec8 models · 141 reports · 1 recall
- Kendall SCD12 models · 118 reports
- Kendall35 models · 58 reports · 1 recall
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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