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Vortex Surgical Inc VS0205.25Recalls & reported problems

Vortex Surgical, Inc. · 25ga EZPass Soft Tip Cannula - 0.5mm Box of 5 · Class 1

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. Dec 16, 2025Open, Classified

    There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.

    Z-1247-2026 · Root cause: Employee error · FDA record ↗

Other Cannula, Ophthalmic devices

All Cannula, Ophthalmic devices →

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