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Surgify Halo | 5.4 mm | Medium 54.085.SHD.H1Recalls & reported problems

Surgify Medical Oy · Class 2

All models of Surgify Halo | 5.4 mm | Medium (2)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

  1. Apr 30, 2026Class IIOpen, Classified

    Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).

    Z-2568-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

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Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page