DeRoyal 89-3940Recalls & reported problems
Deroyal Industries, Inc. · GENERAL LAPAROSCOPIC PACK · Class 2
Data updated Oct 16, 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 00749756571524), received between Mar 14, 2024 and Mar 14, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Component Missing” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Component Missing1
- No Apparent Adverse Event1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 14, 2024Component Missing; No Apparent Adverse Event; Component Missing; No Apparent Adverse Event
THERE WERE ONLY 9 GAUZE RF IN THE PACK (SUPPOSED TO BE 10).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18904144 ↗
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- Medline Industries, Inc. CDS860016RMedline Industries, Inc. · laparoscopy kit4 recalls0 reports
- Medline Industries, Inc. DYNJ21927RMedline Industries, Inc. · laparoscopy kit4 recalls0 reports
- Medline Industries, Inc. DYNJ0426069NMedline Industries, Inc. · laparoscopy kit4 recalls0 reports
- Medline Industries, Inc. DYNJ58561DMedline Industries, Inc. · laparoscopy kit3 recalls1 report
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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