VersaOne RC12STSRecalls & reported problems

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.

2 other recalls cover devices cleared under the same FDA submission (K201805); they may or may not involve this specific model.

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. Mar 22, 2023Open, Classified

   There is a manufacturing non-conformance that may result in a metal shaving (burr) on the inside of the VersaOneTM Reusable Positioning Cannula, located where the Cannula and Body components are welded together.

   Z-1465-2023 · Root cause: Process control · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K201805. One submission often covers many models, so check the product and lot details in each record.

• Z-1464-2023 · Mar 22, 2023 · Open, Classified
  VersaOne Reusable Positioning Cannula 11mm Standard, Model Number RC11STS
• Z-1463-2023 · Mar 22, 2023 · Open, Classified
  VersaOne Reusable Positioning Cannula 8 mm Standard, Model Number RC8STS