Medline SSN103235Recalls & reported problems
Medline Industries, Inc. · SYR W/NDLE,SAFETY,23GX1, 3ML · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10193489037906), received between Jul 26, 2024 and Sep 16, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Connection Problem” (1 report).
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
- Connection Problem1
- Insufficient Device Problem Information1
- Loose or Intermittent Connection1
- Tear, Rip or Hole in Device Packaging1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Needle Stick/Puncture1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 16, 2026Loose or Intermittent Connection; Tear, Rip or Hole in Device Packaging
Patient problems: Needle Stick/Puncture
MAUDE report 50794067 ↗MalfunctionNov 22, 2024Connection Problem; Connection Problem
IT WAS REPORTED THAT "ONCE THE VACCINE WAS IN THE SYRINGE THE NEEDLE SLOWLY BEGAN TO UNSCREW FROM THE SYRINGE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20765089 ↗MalfunctionJul 26, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
THE REPORTING FACILITY INDICATED THAT AN ISSUE WAS IDENTIFIED WHERE "THE PROTECTIVE SHEATH" OF THE SAFETY NEEDLE "COMES LOOSE". TO DATE, NO INFORMATION HAS BEEN RECEIVED TO INDICATE THAT THERE WAS A SYRINGE- RELATED DEFECT RELATED TO THE ORIGINAL REPORT OR THAT THE REPORT INVOLVED AN OUT OF SPECIFICATION SYRINGE. TO DATE, NO INFORMATION HAS BEEN RECEIVED TO INDICATE THAT THE SAFETY NEEDLE DETACHED OR DISLODGED FROM THE SYRINGE. 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. NO SAMPLES AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19834893 ↗
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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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