Medline SYRI003314Recalls & reported problems
Medline Industries, Inc. · SYR W/NDLE,INSLN,0.3ML,31GX5/16" · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10193489008623), received between Jul 26, 2024 and Jul 26, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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
- Insufficient Device Problem Information2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 26, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
THE REPORTING FACILITY INDICATED THAT THE NEEDLE IS RETRACTING DURING USE. 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 A USER OR A PATIENT EXPERIENCED A DEATH, SERIOUS INJURY, MEDICAL INTERVENTION, FOLLOW-UP CARE, OR OTHER ADVERSE HEALTH IMPACT ASSOCIATED WITH THE REPORTED PROBLEM/ISSUE. NO SAMPLE AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19834935 ↗MalfunctionJul 26, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
THE INITIAL REPORTER INDICATED THAT THE SYRINGE WAS "NOT PROPERLY DRAWING UP MEDICATION." NO SERIOUS INJURY OR ADVERSE IMPACT TO A PATIENT OR TO A 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. NO SAMPLE AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19834760 ↗
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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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