Stryker Instruments Div. of Stryker Corporation: Medical Device Recall in 2012 - (Recall #: Z-1809-2012)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

Product Description:

T5 Hytrel Zipper Toga. Product Usage: The togas are intended to provide a barrier between the operating room and the members of the surgical team in order to help protect against contamination and/or exposure of infectious body fluids and harmful microorganisms.

Product Classification:

Class II

Date Initiated: June 1, 2012

Date Posted: June 20, 2012

Recall Number: Z-1809-2012

Event ID: 61848

Reason for Recall:

The clear tape, that is intended to aid in the prevention of patients fluids from contacting the surgeon/surgical staff through the sleeve seam of the toga, was not applied during the manufacturing process. Stryker has received 5 complaints associated with the defective seams which allowed bleed through of bodily fluids.

Status: Terminated

Product Quantity: 23,653 ( past 3 years) 47937 all years

Code Information:

Part 0400-821-100, 0400-841-100 , 0400-851-100 0400-851-100S1, and 0400-851-100S2 all lots

Distribution Pattern:

Worldwide Distribution - US (nationwide) including the states of: AK, AL, AZ, CA, CO, DE, FL, GA, IA, ID, IL, IN, KY, LA, MA, ME, MI, MN, MO, MS, MT, NC, ND, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA, WI, WV and the country of SWITZERLAND

Voluntary or Mandated:

Voluntary: Firm initiated