Stryker Spirit Select Bed Recall for Potential Entrapment Risk
Stryker is recalling Spirit Select Beds with high rail siderails due to non-compliance with safety standards and a potential risk of entrapment.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk-of-harm product (entrapment) where no specific injuries or illnesses have been reported in the source text, fitting the criteria for a High severity score.
Plain-English summary
Stryker Medical Division of Stryker Corporation is recalling the Spirit Select Bed, Model 5700 Spirit Plus, specifically units equipped with the high rail siderail option. The recall is issued because these beds may not be compliant with the IEC 60601-2-52/C1:2010 safety standard.
The primary hazard identified is a potential risk of entrapment. The affected products were distributed to facilities in 48 US states, the District of Columbia, and Canada.
Healthcare facilities and consumers should check their equipment serial numbers against the list provided in the official recall notice to determine if their units are affected. If a unit is included in the recall, users should follow the instructions provided by Stryker for remediation or replacement.
The recalled product
- Product
- The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option
- Manufacturer
- Stryker Medical Division of Stryker Corporation
- Category
- Medical Device — Hospital Bed
- Hazard
Distribution
Part of a larger recall action
This product is one of 2 recalled by Stryker Medical Division of Stryker Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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Same hazard · entrapment
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