Stryker Instruments Div. of Stryker Corporation: Medical Device Recall in 2013 - (Recall #: Z-1501-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

Stryker Instruments 0400-840-000 T4 Toga, Zipper, Large, Sterile, EO; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganismsand particulate material.

Product Classification:

Class II

Date Initiated: May 23, 2013

Date Posted: June 12, 2013

Recall Number: Z-1501-2013

Event ID: 65321

Reason for Recall:

Based on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for togas within the second and third year of shelf life. The test method used involved high heat to accelerate the aging of the packaging. Stryker is conducting additional testing and assessing this pr

Status: Terminated

Product Quantity: 9,930 units (993 boxes)

Code Information:

1105390, 1107543

Distribution Pattern:

USA Nationwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated