Medline SYRS101272FRecalls & reported problems
Medline Industries, Inc. · SAFETY SYRINGE, 1ML 27GX0.5" · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 30888277222483), received between Mar 8, 2024 and Apr 6, 2024 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 reports).
1 FDA recall record name this device's identifier, 1 still open.
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
Recalls naming this device
- May 9, 2024Class IIOpen, Classified
Products in distribution were found by FDA to be to be substantially different from the current cleared 510(k)s with a major change or modification to the device s intended use.
Z-3074-2024 · Root cause: Other · Recall details · FDA record ↗
Most reported problems
Device problems
- Detachment of Device or Device Component2
- Suction Problem2
- Break1
- Connection Problem1
- Leak/Splash1
- Loose or Intermittent Connection1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
- Needle Stick/Puncture1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 6, 2024Loose or Intermittent Connection; Loose or Intermittent Connection
IT WAS REPORTED THAT THE NEEDLE-SYRINGE CONNECTION WAS NOTED TO BE LOOSE DURING USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19056744 ↗MalfunctionApr 6, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE NEEDLE DETACHED FROM THE SYRINGE WHEN ATTEMPTING TO ACTIVITY THE NEEDLE SAFETY FEATURE.
Patient problems: Needle Stick/Puncture
MAUDE report 19056734 ↗MalfunctionApr 5, 2024Suction Problem; Suction Problem
IT WAS REPORTED THAT THE SYRINGE DRAWS IN AN "ABUNDANCE OF AIR."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19055756 ↗MalfunctionApr 5, 2024Break; Break
IT WAS REPORTED THAT THE SYRINGE PLUNGER WAS "BROKEN AND IT WAS NOT IN THE PACKAGING."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19055748 ↗MalfunctionMar 27, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE NEEDLE FEELS "FLIMSY" AND THAT IT DETACHED FROM THE SYRINGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18984528 ↗MalfunctionMar 8, 2024Leak/Splash; Suction Problem; Connection Problem; Leak/Splash; Suction Problem; Connection Problem
IT WAS REPORTED THAT THE NEEDLE-SYRINGE CONNECTION WAS INADEQUATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18865238 ↗
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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026 · each recall links to the FDA recall notice
- 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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