Magellan 8881882812Recalls & reported problems
Cardinal Health, Inc. · 1 mL Tuberculin Safety Syringe,Permanent Needle · Class 2
All models of Magellan (29)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10884521005921), received between Jul 12, 2017 and Feb 3, 2023 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (3 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.
Most reported problems
Device problems
- Device Contaminated During Manufacture or Shipping3
- Break1
- Detachment of Device or Device Component1
- Fail-Safe Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- No Patient Involvement3
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 3, 2023Fail-Safe Problem; Fail-Safe Problem
THE CUSTOMER REPORTED WHILE IN THE OPERATING ROOM, THE DOCTOR ATTEMPTED TO USE THE MAGELLAN 1ML TUBERCULIN SAFETY SYRINGE TO DRAW UP MEDICATION FOR THE PATIENT'S SPINAL ANESTHESIA AND WHEN PULLING OFF THE CAP, THE SAFETY MECHANISM DISENGAGED PREVENTING HIM FROM DRAWING UP THE MEDICATION. THIS HAPPENED WITH MULTIPLE SYRINGES. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16296918 ↗MalfunctionJul 29, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
THE CUSTOMER REPORTED THAT THE ACTUAL NEEDLE DISCONNECTS FROM THE SYRINGE AND REMAINS IN THE PATIENT. IT HAS OCCURRED 4 OR 5 TIMES. PER ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2022, NO NEEDLE WAS LEFT BEHIND IN THE PATIENT. THE REPORTED PROBLEM WITH THE NEEDLE COMING OFF THE SYRINGE WAS NOTICED PRIOR TO ANY PATIENT CONTACT. THIS WAS NOTICED 4 TO 5 TIMES. THE PART THAT DETACHED IS THE ENTIRE HUB THAT HOLDS THE NEEDLE AND THEN, IS INSERTED INTO THE SYRINGE. THEY COULD SEE THAT THE PIECE THAT HOLDS THE NEEDLE WAS NOT FLUSH WITH THE END OF THE SYRINGE. IT WAS ABOUT HALF WAY INTO (OR HALF WAY OUT OF) THE SYRINGE. THERE WAS NO MEDICAL INTERVENTION REQUIRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15136110 ↗MalfunctionApr 21, 2022Break; Break
THE CUSTOMER REPORTED THAT THE NURSES ARE COMPLAINING THEY ARE BROKEN. SOME NEEDLES ARE BENT, AND SOME ARE FALLING APART. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14167026 ↗MalfunctionJul 17, 2017Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
THE CUSTOMER REPORTS A THIN LIQUID IN THE SYRINGE.
Patient problems: No Patient Involvement
MAUDE report 6718461 ↗MalfunctionJul 17, 2017Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
THE CUSTOMER REPORTS A THIN LIQUID IN THE SYRINGE.
Patient problems: No Patient Involvement
MAUDE report 6718267 ↗MalfunctionJul 12, 2017Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
THE CUSTOMER STATES LIQUID RESIDUE IN THE SYRINGE.
Patient problems: No Patient Involvement
MAUDE report 6706132 ↗
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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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