Medline Industries, Inc. DYNJ54701BRecalls & reported problems
Medline Industries, Inc. · EP FEMORAL PACK SAFETY #1 · Class 1
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 10193489222685), received between Dec 17, 2020 and Mar 18, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (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
- Break2
- Entrapment of Device1
- Material Fragmentation1
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.
MalfunctionMar 18, 2024Break; Material Fragmentation; Break; Material Fragmentation
IT WAS REPORTED THAT THE TIP OF SYRINGE COMPONENT BROKE OFF WHILE FLUSHING A PIGTAIL CATHETER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18921560 ↗MalfunctionDec 17, 2020Break; Entrapment of Device
IT WAS REPORTED, "THE TIP OF A SYRINGE BROKE OFF AND GOT STUCK INSIDE THE LUMEN OF A PIGTAIL CATHETER."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11028986 ↗
Other Ear, nose, and throat surgical tray devices
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- Medline Industries, Inc. DYNJ17005IMedline Industries, Inc. · Ear, nose, and throat surgical tray4 recalls0 reports
- Medline Industries, Inc. DYNJ51934AMedline Industries, Inc. · Ear, nose, and throat surgical tray4 recalls0 reports
- Medline Industries, Inc. DYNJ66509AMedline Industries, Inc. · Ear, nose, and throat surgical tray3 recalls1 report
- Medline Industries, Inc. CDS984899GMedline Industries, Inc. · Ear, nose, and throat surgical tray3 recalls0 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 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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