Monoject 8881501160 (UDI 20192253035299)Recalls & reported problems
Cardinal Health, Inc. · 1 mL Tuberculin Syringe Detachable Needle · 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 20192253035299), received between May 4, 2024 and Oct 23, 2024 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (5 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.
Reports received per month
Most reported problems
Device problems
- Insufficient Device Problem Information5
Patient problems
- No Clinical Signs, Symptoms or Conditions5
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 23, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
CUSTOMER FEEDBACK: THE CUSTOMER REPORTED MULTIPLE "BURS" ON THE NEEDLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20511695 ↗MalfunctionAug 27, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
THE CUSTOMER REPORTED THAT THERE WAS AN OPEN NEEDLE INSIDE THE CLINIC'S BOX OF SYRINGES AND THE PERSON UNPACKING THE BOX GOT STABBED WHEN SHE REACHED IN. SHE IS BLEEDING BECAUSE OF IT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20082275 ↗MalfunctionJun 24, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
THE WRONG NEEDLE ON SYRINGES. ON (B)(6) 2024 THE INITIAL REPORTER PROVIDED A PHOTO STATING THAT THE PHOTO SHOWS THE 2 DIFFERENT 1 ML TUBERCULIN SYRINGES W/25 G NEEDLE. THE SYRINGE ON THE LEFT IS WHAT THEY PREVIOUSLY ORDERED AND RECEIVED. THE PREVIOUS NEEDLE IS DIFFERENT AND DOESN'T HAVE A "NIPPLE" ON TOP OF THE PLUNGER. THE SYRINGE ON THE RIGHT IS THE ONE THEY NOW RECEIVED AND THE PLUNGER IS VERY FLIMSY AND HAS A TENDENCY TO BREAK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19592106 ↗MalfunctionMay 4, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
THE CUSTOMER REPORTED THAT THE NEEDLES ARE SMALLER THAN BEFORE AND DO NOT FIT THE PLUNGER. THEY PROVIDED TWO PHOTOS AND STATED THAT THE ORANGE NEEDLE HUB IS THE UNIT THEY RECENTLY RECEIVED, BUT THEY SAY THE NEEDLE SIZE IS DIFFERENT, AND IS MUCH SMALLER - LIKE A 27G INSTEAD OF A 25G. THE COLOR OF THE NEEDLE HUB HAS ALSO CHANGED AND THEY HAVE CONCERNS OVER THE PLUNGER AND STATED THAT THE NEEDLE WON'T STAY ON. ADDITIONAL INFORMATION RECEIVED ON 13MAR2024 CLARIFIED THAT THE HUB WON'T STAY ON THE SYRINGE WHILE IN USE. THE COLOR OF THE HUB HAS CHANGED (FROM RED TO ORANGE, ORANGE TYPICALLY MEANS A 27G NEEDLE, INSTEAD OF THE RED 25G NEEDLE). THE PLUNGER IS CHANGED (FROM STANDARD TO ZERO-WASTE, WHICH MAKES IT DIFFICULT TO READ THE VOLUME INDICATOR LINES). THESE CHANGES HAVE MADE THE STAFF VERY UNHAPPY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19244510 ↗MalfunctionMay 4, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
THE CUSTOMER REPORTED THE THE CAPS ARE FLIMSY. NOT EVERY SYRINGE, BUT IT HAPPENS ON A LOT OF THEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19244506 ↗
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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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