Medline Industries, Inc. DYNJ0396069FRecalls & reported problems
Medline Industries, Inc. · TR-SEPTO-RHINOPLASTY PK-LF · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10889942065714), received between Mar 14, 2018 and Mar 14, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Contamination With Biological Material” (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.
Most reported problems
Device problems
- Device Contamination With Biological Material1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 14, 2018Device Contamination With Biological Material
AFTER PROCEDURE STARTED, A HAIR WAS FOUND IN THE PACK ON THE OUTSIDE OF THE BASIN. THE SURGICAL TEAM WAS MADE AWARE. THIS DID NOT REACH THE PATIENT, HOWEVER, IT WAS NOT SAVED SINCE THE PROCEDURE WAS ALREADY PROGRESSING, AND STAFF NEEDED TO WORK QUICKLY TO REPLACE SUPPLIES. PER SITE REPORTER: THE FIELD REPRESENTATIVE WAS NOTIFIED AND HE WILL OPEN A COMPLAINT WITH MEDLINE'S QUALITY TEAM.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7337320 ↗
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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