Stryker SmartLife Large Aseptic Housing Recall for Weld Separation
Stryker is recalling 302 SmartLife Large Aseptic Housings due to complaints of housing deterioration and weld separation caused by improper cleaning practices.
What this means for you
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, and the hazard involves structural integrity (weld separation) without reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Stryker Instruments Division of Stryker Corporation is recalling 302 units of the Stryker SmartLife Large Aseptic Housing (model 7126-120-000). The affected units were manufactured between March 18, 2015, and January 31, 2017. The recall was initiated following complaints regarding deterioration to the housing and the top and bottom housing separating at the weld.
The issue is attributed to the use of cleaning practices outside of the High-Intensity Focused Ultrasound (HIFU) system, which can lead to the housing separating at the weld. The affected units were distributed to France and Germany; no domestic distribution is reported.
Consumers and healthcare facilities should stop using the affected devices and contact Stryker Instruments for further instructions on correction or replacement.
The recalled product
- Product
- Stryker SmartLife Large Aseptic Housing (7126-120-000)
- Manufacturer
- Stryker Instruments Div. of Stryker Corporation
- Affected units
- 302
Distribution
Distribution scope not specified by the agency.
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