Medline DNSC83086ARecalls & reported problems
Medline Industries, Inc. · SYRINGE,LUER LOCK,5ML · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 40888277040435), received between Mar 18, 2024 and Feb 11, 2025 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Contamination” (3 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Contamination3
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 11, 2025Break; Break
ACCORDING TO THE FACILITY ON (B)(6) 2024, THE SYRINGE WAS FOUND BROKEN INSIDE THE PACK BEFORE SURGERY. THERE WAS ONE BROKEN, FLANGE/FINGER GRIP OFF THE SYRINGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21354890 ↗MalfunctionApr 1, 2024Contamination; Contamination
IT WAS REPORTED THAT HAIR WAS NOTED WITHIN THE SYRINGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19009704 ↗MalfunctionApr 1, 2024Contamination; Contamination
IT WAS REPORTED THAT HAIR WAS NOTED WITHIN THE SYRINGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19009702 ↗MalfunctionMar 18, 2024Contamination; Contamination
IT WAS REPORTED THAT "DEBRIS" WAS FOUND WITHIN THE SYRINGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18922273 ↗
Other Syringe, piston devices
- BD Luer-Lok 309657Becton, Dickinson And Company · Syringe, piston1,266 reports
- BD Luer-Lok 309653Becton, Dickinson And Company · Syringe, piston948 reports
- BD Luer-Lok 309628Becton, Dickinson And Company · Syringe, piston862 reports
- N/A 302995Becton, Dickinson And Company · Syringe, piston1 recall537 reports
- BD Plastipak Syringe 300865Becton, Dickinson And Company · Syringe, piston515 reports
- N/A 302830Becton, Dickinson And Company · Syringe, piston462 reports
- N/A 302832Becton, Dickinson And Company · Syringe, piston424 reports
- BD Ultra-Fine 328468Becton, Dickinson and Company Inc · Syringe, piston323 reports
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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