Steris recalls six models of InnoWave Sonic Irrigators due to unclear FDA test acceptance criteria during installation. Affected units have specific serial numbers. Consumers should check their serial numbers and contact Steris for details.
A recent FDA inspection at the firm identified that the foil test performed during installation of the device does not have clear acceptance criteria.
Steris is recalling six models of InnoWave Sonic Irrigators because a recent FDA inspection found that the foil test used during installation lacks clear acceptance criteria. This could lead to improper device function, but the recall does not specify immediate safety risks or injuries.
The FDA inspection identified that the foil test performed during installation does not have clear acceptance criteria. This means the device might not function correctly, but the recall does not indicate a risk of injury or serious harm during normal use.
Surgical instrument users who own any of the six InnoWave Sonic Irrigator models (PCF, Pro, Ultra, Ultra+, Unity, or ECO) with the listed serial numbers. Healthcare professionals and surgical staff are most at risk.
Check if your InnoWave Sonic Irrigator has a serial number listed in the provided list (e.g., 11167539801, 11167539802, etc.). The recall covers six specific models: PCF, Pro, Ultra, Ultra+, Unity, and ECO.
Look for the serial number on your device and compare it to the list of affected serial numbers provided in the recall.
Reach out to Steris Corporation for further instructions on how to address the issue.
The recall affects six models: PCF, Pro, Ultra, Ultra+, Unity, and ECO.
Check the serial number on your device against the list of affected serial numbers provided in the recall.
The recall does not indicate a risk of injury or serious harm during normal use. The issue is related to unclear test criteria, not immediate safety hazards.
We’ve drafted a message you can send Steris to request your refund or repair — edit it as you like.
Subject: Recall Z-2700-2020 — Steris Steris Hello, I own a Steris that is covered by recall Z-2700-2020 from Steris. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
