Stryker T4 Toga Recall Due to Potential Sterile Barrier Breach
Stryker is recalling T4 Toga sterile surgical gowns because accelerated aging tests indicate a potential breach in the sterile barrier packaging.
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 risk-of-harm product (sterile barrier breach) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Stryker Instruments Division of Stryker Corporation is recalling 9,930 units (993 boxes) of Stryker Instruments 0400-840-000 T4 Toga, Zipper, Large, Sterile, EO. These single-use surgical gowns are intended to protect patients, healthcare personnel, and operating room personnel against contamination and exposure to infectious bodily fluids. The products were distributed nationwide in the United States.
The recall was initiated following an accelerated aging test for the product packaging. The testing indicated a potential for a breach in the sterile barrier within the header bag and potentially the blue sterilization wrap. This potential breach could occur within the second and third year of the product's shelf life. The test method used high heat to accelerate the aging of the packaging. Stryker is currently conducting additional testing and assessing the product.
The recalled product
- Product
- 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
- Manufacturer
- Stryker Instruments Div. of Stryker Corporation
- Category
- Medical Device — Surgical Gowns
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 (2)
- 1105390
- 1107543
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 16 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.
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