Stryker Instruments Div. of Stryker Corporation: Medical Device Recall in 2015 - (Recall #: Z-1077-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

Flyte Togas are components of the Stryker Flyte System and are intended to be worn over any Stryker Flyte Helmet. This toga provides Level 1 and 4 protection according to the Association for the Advancement of Medical Instrumentation (AAMI) Liquid Barrier Performance and Classification System (PB70:2012).

Product Classification:

Class III

Date Initiated: December 22, 2014

Date Posted: February 18, 2015

Recall Number: Z-1077-2015

Event ID: 70332

Reason for Recall:

A single lot (11121171) of Flyte Toga Peel-away X-Large (catalog number 0408-830-100) was labeled with an incorrect expiration date of 2412-12-01. The correct expiration date should have read 2014-12-01.

Status: Terminated

Product Quantity: 1530 units (170 cases)

Code Information:

Part/Catalog number: 0408-830-100 Lot number: 11121171 Expiration date (as printed): 2412-12-01

Distribution Pattern:

Nationwide Distribution including AL, AR, AZ, IA, IL, IN, LA, MA, NC, NE, NM, SC, TN, TX, WI, and WV.

Voluntary or Mandated:

Voluntary: Firm initiated