Medline Industries, Inc. PAIN9025Recalls & reported problems
Medline Industries, Inc. · TRAY,CON,EPID,19G REINF,W/TUOH · Class 2
Data updated Oct 18, 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
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10193489777697), received between Apr 13, 2023 and Sep 30, 2026 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Material Deformation” (1 report).
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 18, 2026.
Reports received per month
Recalls naming this device
- Oct 16, 2024Class IIOpen, Classified
The connectors may not allow catheters to be inserted as intended if the connector is not in the fully open position.
Z-0509-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported problems
Device problems
- Appropriate Device Problem Term/Code Not Available1
- Material Deformation1
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Material Deformation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951322 ↗InjuryApr 13, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
ACCORDING TO THE FACILITY ON (B)(6) 2023 "THE PATIENTS EPIDURAL CATHETER BECAME DISLODGED FROM THE HUB AT THE CONNECTOR AND THE EPIDURAL WAS REPLACED AS PARTS OF THE EPIDURAL CATHETER LOOKED TO BE DISINTEGRATED."
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 16736621 ↗
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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 · each recall links to the FDA recall notice
- 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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