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DeRoyal 89-6219Recalls & reported problems

Deroyal Industries, Inc. · PELVIC EXAM TRAY · Class 2

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

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

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

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. May 30, 2023Open, Classified

    The outer package seal could be open, or compromised which affects the sterility of the procedure pack inside.

    Z-2089-2023 · Root cause: Process control · FDA record ↗

Other Pelvic exam kit devices

All Pelvic exam kit devices →

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