DeRoyal 89-9341Recalls & reported problems
Deroyal Industries, Inc. · ENT NASAL TRACEPACK · Class 2
Data updated Oct 13, 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 00749756913263), received between Sep 20, 2019 and Sep 20, 2019 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Device Misassembled During Manufacturing /Shipping” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Device Misassembled During Manufacturing /Shipping2
- Manufacturing, Packaging or Shipping Problem2
Patient problems
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 20, 2019Device Misassembled During Manufacturing /Shipping; Manufacturing, Packaging or Shipping Problem; Device Misassembled During Manufacturing /Shipping; Manufacturing, Packaging or Shipping Problem
THERE WAS NON X-RAY DETECTABLE GAUZE IN A CONVENIENCE KIT WHEN IT SHOULD HAVE BEEN X-RAY DETECTABLE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9098139 ↗MalfunctionSep 20, 2019Device Misassembled During Manufacturing /Shipping; Manufacturing, Packaging or Shipping Problem; Device Misassembled During Manufacturing /Shipping; Manufacturing, Packaging or Shipping Problem
THERE WAS NON X-RAY DETECTABLE GAUZE IN A CONVENIENCE KIT WHEN IT SHOULD HAVE BEEN X-RAY DETECTABLE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9097743 ↗
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- Halyard KRIV26-02_0003Avid Medical, Inc. · General surgery tray4 recalls0 reports
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- Medline Industries, Inc. CDS983467JMedline Industries, Inc. · General surgery tray4 recalls0 reports
- Medline Industries, Inc. ACC010690Medline Industries, Inc. · General surgery tray4 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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