Monoject 8881250248Recalls & reported problems
Cardinal Health, Inc. · Standard Hypodermic Needle,Polypropylene Hub · Class 2
All models of Monoject (164)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 20884521006222), received between Aug 21, 2020 and Dec 15, 2020 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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
- Detachment of Device or Device Component3
- Disconnection1
- Fitting Problem1
- Fluid/Blood Leak1
Patient problems
- No Consequences Or Impact To Patient3
- Needle Stick/Puncture1
- No Clinical Signs, Symptoms or Conditions1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 15, 2020Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT THE CAPS WERE LOOSE AND THE NEEDLES WERE LEAKING AROUND THE HUB. THERE WERE NO INJURIES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11011881 ↗MalfunctionSep 30, 2020Fitting Problem; Detachment of Device or Device Component; Fitting Problem; Detachment of Device or Device Component
THE CUSTOMER REPORTED THAT WHEN THEY OPENED THE BOX, MANY OF THE NEEDLES DON'T ATTACH TO SYRINGE IN A WAY THAT, THE CAP CAN STAY ON. IT¿S LIKE THE NEEDLE THREADS ARE TOO DEEP FOR THE CAP TO BE RE-APPLIED. THE CUSTOMER FURTHER STATED THAT THIS ISN'T GOOD, AS THEY CARRY EUTHANASIA SOLUTION TO A PET OR VACCINES, ETC. THERE WAS NO PATIENT INJURY REPORTED.
Patient problems: Needle Stick/Puncture; No Consequences Or Impact To Patient
MAUDE report 10610170 ↗MalfunctionSep 23, 2020Detachment of Device or Device Component; Detachment of Device or Device Component
THE CUSTOMER REPORTED THAT WHEN THEY BREAK THE SEAL ON THE CAP, THE NEEDLE FALLS OUT. IT DOES NOT STAY SEATED IN THE HUB, AS IT NORMALLY WOULD. THERE WAS NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10575393 ↗MalfunctionAug 21, 2020Disconnection; Disconnection
CUSTOMER REPORTS: WHEN TWISTING OFF THE PLASTIC TOP, THE NEEDLE SEPARATES FROM THE HUB AND FALLS OFF.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10437146 ↗MalfunctionAug 21, 2020Detachment of Device or Device Component; Detachment of Device or Device Component
THE CUSTOMER REPORTS THAT WHEN THEY TWIST OFF THE PLASTIC TOP, THE NEEDLE SEPARATES FROM THE HUB AND FALLS OFF. ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER ON 20-AUG-2020 STATED THAT WHEN THEY TWISTED THE PLASTIC SHEATH OFF, THE NEEDLE WOULD FALL OFF THE PLASTIC HUB AND ONTO THE TABLE. SHE SAID THAT THEY HAD MANY NEEDLES DO THIS IN ONE BOX. THEY OPENED A SECOND BOX AND WHEN THEY TRIED TO USE THE SECOND BOX IT WOULD DO THE SAME THING, WHEN THEY TWISTED THE PLASTIC SHEATH OFF, THE NEEDLE WOULD FALL OFF THE HUB AND ONTO THE TABLE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10437126 ↗
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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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