The Recall Desk
HighFDA (Devices)·Z-0438-2019·Announced 2018-11-21

Stryker Spirit Plus Bed Recall for Potential Entrapment Risk

Stryker is recalling 20,030 Spirit Plus hospital beds with high rail siderails due to non-compliance with safety standards and a potential risk of patient entrapment.

What this means for you

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 injuries have been reported, which aligns with the 'High' severity criteria.

Plain-English summary

Stryker Medical Division of Stryker Corporation is recalling 20,030 units of the Spirit Plus Bed, Model 5600, specifically those equipped with the high rail siderail option. The recall was initiated because these beds may not be compliant with the IEC 60601-2-52/C1:2010 safety standard.

The primary hazard associated with this recall is a potential risk of entrapment. The affected products were distributed to facilities in all 50 US states, the District of Columbia, and Canada. The recall covers specific serial numbers listed in the official FDA documentation.

Healthcare facilities and consumers who possess these specific beds should contact Stryker for instructions on how to proceed with the recall. The source text does not report any specific injuries or illnesses associated with this defect.

The recalled product

Product
The Spirit Plus Bed, Model 5600 Spirit Plus /with high rail siderail option
Affected units
20,030

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.

See all 2 products in this recall →