Medline Industries, Inc. DYNJ82657Recalls & reported problems
Medline Industries, Inc. · T AND A PACK · 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 10195327199302), received between Aug 17, 2026 and Sep 14, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Break1
- Scratched Material1
- Thermal Decomposition of Device1
Patient problems
- Burn(s)1
- 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 14, 2026Break; Thermal Decomposition of Device
It was reported that insulation on the suction cautery burning off during use, resulting in clear break of the product.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50763055 ↗MalfunctionAug 17, 2026Scratched Material
Patient problems: Burn(s)
MAUDE report 50288717 ↗
Other Ear, nose, and throat surgical tray devices
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- 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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