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DeRoyal 89-10553Recalls & reported problems

Deroyal Industries, Inc. · CMC GYN LAPAROSCOPY PACK · 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. Apr 17, 2023Open, Classified

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

    Z-1691-2023 · Root cause: Nonconforming Material/Component · FDA record ↗

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