The Recall Desk

FDA (Devices) recall action 81211

Stryker Medical Division of Stryker Corporation recalled 2 products on 2018-11-21

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2018-11-21
Critical
0
Units
20,030

Why these products were recalled

The beds with the high rail side rail option may not be complaint with IEC 60601-2-52/C1:2010. There is a potential risk of entrapment.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–2 of 2

  • HighFDA (Devices)··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.

    Product
    The Spirit Plus Bed, Model 5600 Spirit Plus /with high rail siderail option
    Category
    Distribution
    50 states
  • HighFDA (Devices)··2018-11-21

    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.

    Product
    The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option
    Category
    Distribution
    50 states