MEDLINE SSN103255Recalls & reported problems
Medline Industries, Inc. · SYR W/NDLE,SAFETY,25GX1, 3ML · Class 2
Data updated Oct 16, 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 10193489037920), received between Nov 14, 2024 and Aug 21, 2025 — classified as 2 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
- Detachment of Device or Device Component1
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.
MalfunctionAug 21, 2025Connection Problem; Connection Problem
IT WAS REPORTED THAT THE NEEDLES "FALL OFF OF THE SYRINGE ALONG WITH THE SAFETY CAP".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22861312 ↗MalfunctionNov 14, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE FACILITY THE "NEEDLE IS FALLING OFF/OUT OF THE SYRINGE WHEN TRYING TO CAP THE NEEDLE AFTER USE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20682840 ↗
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- BD Plastipak Syringe 300865Becton, Dickinson And Company · Syringe, piston515 reports
- N/A 302830Becton, Dickinson And Company · Syringe, piston462 reports
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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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