Medline SYR103205Recalls & reported problems
Medline Industries, Inc. · SYR W/NDLE,HYPODERM,LL,20GX1", 3ML · Class 2
Data updated Oct 18, 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 10080196449408), received between Mar 18, 2024 and Jul 26, 2024 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component2
- Insufficient Device Problem Information2
- Appropriate Device Problem Term/Code Not Available1
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.
MalfunctionJul 26, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
ACCORDING TO THE CUSTOMER, THERE HAVE BEEN THREE INCIDENCES WHERE NURSES ARE RECAPPING THE HYPODERMIC SYRINGES THE NEEDLES PIERCE THE SIDE OF THE CAP AND ENTER THE NURSE'S FINGER'. THE CUSTOMER REPORTED THAT NEEDLE STICKS HAPPENED PRIOR TO USING THE NEEDLES ON PATIENTS. THE CUSTOMER REPORTED THERE WAS NO IMMEDIATE OR FOLLOW UP INTERVENTION REQUIRED', NO POST-EXPOSURE FACILITY PROTOCOL REQUIRED, AND THE NURSES ARE DOING FINE'.NO SAMPLE AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19834933 ↗MalfunctionJul 26, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
THE INITIAL REPORTER INDICATED THAT NEEDLE DETACHMENT FROM THE SYRINGE OCCURRED. NO SERIOUS INJURY OR ADVERSE HEALTH IMPACT WAS ORIGINALLY REPORTED. TO DATE, NO INFORMATION HAS BEEN RECEIVED TO INDICATE THAT A USER OR A PATIENT EXPERIENCED A DEATH, SERIOUS INJURY, MEDICAL INTERVENTION, FOLLOW-UP CARE, OR OTHER ADVERSE HEALTH IMPACT ASSOCIATED WITH THE REPORTED PROBLEMS/ISSUES. NO SAMPLES AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19834869 ↗MalfunctionMay 2, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
ACCORDING TO THE CUSTOMER ON 4/4, "WHILE DRAWING UP A MEDICATION, A NURSE NOTICED A HAIR FLOATING IN THE SYRINGE. IT APPEARS TO BE AN EYELASH. THE MEDICATION WAS DISCARDED AND THE SYRINGE WAS ISOLATED".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19229303 ↗MalfunctionApr 1, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE "BLACK STOPPER" OF THE SYRINGE PLUNGER DETACHED DURING USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19016239 ↗MalfunctionMar 18, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT NEEDLE DETACHMENT FROM THE SYRINGE OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18922649 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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