The Recall Desk

FDA (Devices) recall action 66468

Stryker Medical Division of Stryker Corporation recalled 2 products on 2014-01-08

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
2014-01-08
Critical
0
Units
217,538

Why these products were recalled

Stryker Medical has identified a potential issue associated with Secure II and S3 Med/Surg beds built between April 2nd, 2005 and July 26th, 2011. The affected beds have the potential to experience damage to the Foot End Cover and/or Power Coil Cable due to reduced clearance between the Foot End Cover and Foot End Lift Header.

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.

1–2 of 2

  • HighFDA (Devices)··2014-01-08

    Stryker S3 Med/Surg Bed Recall for Foot End Cover Damage

    Stryker is recalling S3 Med/Surg beds due to potential damage to the Foot End Cover and Power Coil Cable caused by reduced clearance.

    Product
    S3 Med/Surg Bed Secure II and the 3002 S3 are the beds typically found in the Med-Surg units of the hospitals. The bed is designed for a 15 year expected service life under normal use conditions, and with appropriate periodic maintenance as described in the maintenance manual
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2014-01-08

    Stryker Secure II Med/Surg Beds Recalled for Potential Cover Damage

    Stryker is recalling Secure II and S3 Med/Surg beds due to potential damage to the Foot End Cover and Power Coil Cable caused by reduced clearance.

    Product
    Secure II Med/Surg Bed Secure II and the 3002 S3 are the beds typically found in the Med-Surg units of the hospitals. The bed is designed for a 15 year expected service life under normal use conditions, and with appropriate periodic maintenance as described in the maintenance
    Category
    Distribution
    0 states