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.
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, 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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