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DeRoyal 89-10567Recalls & reported problems

Deroyal Industries, Inc. · OB-OR C-SECTION PACK · Class 1

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
1

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00749756364300), received between Jan 8, 2021 and Jan 8, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Integrity Problem” (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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

  1. Apr 17, 2023Open, Classified

    The custom procedure packs contain light handle covers that have been recalled by another firm.

    Z-1692-2023 · Root cause: Nonconforming Material/Component · FDA record ↗

Most reported problems

Device problems

  • Material Integrity Problem1

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.

  • MalfunctionJan 8, 2021Material Integrity Problem; Material Integrity Problem

    THE DRAPE INCLUDED IN THE CONVENIENCE KIT DOES NOT WORK PROPERLY. IT CONTINUES TO ALLOW FLUID TO LEAK OUT, COMPROMISING STERILITY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11141190 ↗

Other Kit, surgical instrument, disposable devices

All Kit, surgical instrument, disposable devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.