The Recall Desk
HighFDA (Devices)·Z-1810-2012·Announced 2012-06-20

Stryker T4-Hytrel Zipper Toga Recall Due to Missing Tape

Stryker is recalling T4-Hytrel Zipper Togas because clear tape was not applied during manufacturing, allowing bodily fluids to bleed through the sleeve seam.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device failure that compromises the barrier against infectious body fluids, posing a risk of harm to surgical staff, which aligns with the 'High' severity criteria for risk-of-harm products.

Plain-English summary

Stryker Instruments Div. of Stryker Corporation is recalling T4-Hytrel Zipper Togas. These medical devices are intended to provide a barrier between the operating room and the surgical team to help protect against contamination and exposure to infectious body fluids and harmful microorganisms.

The recall is due to a manufacturing defect where clear tape, intended to prevent patient fluids from contacting the surgeon or staff through the sleeve seam, was not applied. Stryker has received five complaints associated with these defective seams, which allowed for the bleed-through of bodily fluids.

The affected products include Part numbers 0400-821-000, 0400-841-000, and 0400-851-000 across all lots. The distribution was worldwide, including nationwide distribution in the United States and Switzerland. Healthcare facilities should stop using these products and contact Stryker for instructions on return or replacement.

The recalled product

Product
T4-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.
Manufacturer
Stryker Instruments Div. of Stryker Corporation
Category
Medical Device — Surgical Barrier
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

  • Part 0400-821-000
  • 0400-841-000
  • and 0400-851-000 all lots

Distribution

Distributed nationwide across the United States.

The notice also names 39 states specifically:

Part of a larger recall action

This product is one of 2 recalled by Stryker Instruments Div. of Stryker Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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