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Steris Corporation

Steris Corporation: 6 recalls posted by FDA since February 2026.

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All recalls (6)

Steris Rapicide PA Part A High-Level Disinfectant

Rapicide PA Part A High-Level Disinfectant may swell if its vented cap is blocked, and liquid may escape when opened.

Moderate risk, FDA, , Device defect

Steris HexaVue Focus Integration System

HexaVue Focus Integration System may mismatch patient information on printed images, causing documentation discrepancies.

Moderate risk, FDA, , Software defect

Steris VERIFY Biological Steam Test Packs and Biological Indicators

Verify biological indicators and test packs may show no growth even if the steam cycle did not achieve the intended spore reduction.

Moderate risk, FDA, , Device defect

ALYON and HarmonyAIR A-Series Surgical Lighting System

The surgical lighting systems may have light intensity control buttons that detach.

Moderate risk, FDA, , Device defect

HarmonyAIR A-Series Surgical Lighting System

The HarmonyAIR A-Series Surgical Lighting System has paint that can chip or peel on its light heads.

Moderate risk, FDA, , Device defect

Steris Barco MNA with HexaVue IP Integration System

The Barco MNA with the HexaVue IP Integration System was made with an incorrect configuration file.

Moderate risk, FDA, , Device defect
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