Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
InnoWave Sonic Irrigator Recalled by Steris Corporation Due to A recent FDA inspection at the firm identified...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Steris Corporation directly.
Affected Products
InnoWave Sonic Irrigator, There are currently six models (PCF, Pro, Ultra, Ultra+, Unity, and ECO) - Product Usage: STERIS InnoWave Sonic Irrigators are intended to thoroughly clean (remove tissue, blood, and other contaminants from) a variety of reusable surgical instruments. The equipment provides sonic irrigation (ultrasonic cavitation) to both interior and exterior of lumened instruments.
Quantity: 1283
Why Was This Recalled?
A recent FDA inspection at the firm identified that the foil test performed during installation of the device does not have clear acceptance criteria.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Steris Corporation
Steris Corporation has 109 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report