Medline SYRI101314Recalls & reported problems
Medline Industries, Inc. · SYR W/NDLE,INSLN,1ML,31GX5/16" · Class 2
Data updated Oct 18, 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 10193489008661), received between Mar 22, 2024 and Jul 26, 2024 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Insufficient Device Problem Information1
- Material Too Soft/Flexible1
- Suction Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 26, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
THE INITIAL REPORTER INDICATED THAT A NEEDLE DID NOT "TIGHTEN DOWN" WITH THE SYRINGE AND THAT DETACHMENT OCCURRED. NO SERIOUS INJURY OR ADVERSE IMPACT TO THE PATIENT OR THE USER 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. DUE TO THE REPORTED PROBLEMS/ISSUES. NO SAMPLES AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19834872 ↗MalfunctionMar 31, 2024Material Too Soft/Flexible; Material Too Soft/Flexible
IT WAS REPORTED THAT THE SYRINGE IS "BENDY."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19009233 ↗MalfunctionMar 22, 2024Suction Problem; Suction Problem
IT WAS REPORTED THAT THE SYRINGE WAS "NOT PROPERLY DRAWING UP MEDICATION."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18961901 ↗
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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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