Steris InnoWave Sonic Irrigator Recalled for Unclear Installation Test Criteria
Steris Corporation is recalling 1,283 InnoWave Sonic Irrigators because an FDA inspection found that the foil test performed during installation lacks clear acceptance criteria.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text describes a procedural deficiency (lack of clear acceptance criteria for a test) rather than a direct defect causing injury or hospitalization, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Steris Corporation is recalling 1,283 units of the InnoWave Sonic Irrigator, which includes six models: PCF, Pro, Ultra, Ultra+, Unity, and ECO. These devices are intended to thoroughly clean reusable surgical instruments by removing tissue, blood, and other contaminants using sonic irrigation.
The recall was initiated after a recent FDA inspection identified that the foil test performed during the installation of the device does not have clear acceptance criteria. The affected units were distributed nationwide in the United States, as well as in Canada, Mexico, and the United Arab Emirates.
Healthcare facilities and users of these devices should contact Steris Corporation for further instructions on how to proceed with the recall and any necessary corrective actions.
The recalled product
- Product
- 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.…
- Manufacturer
- Steris Corporation
- Affected units
- 1,283
Distribution
Distributed nationwide across the United States.
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