Stryker T4 Zipper Toga sterile garments recalled for layer separation
Stryker is recalling T4 Zipper Toga sterile personal protection garments because material layers may separate, creating a risk of exposure to contaminants.
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 garment) where injury has not yet been reported, fitting the High severity criteria for potential exposure to contaminants without confirmed illness.
Plain-English summary
Stryker Instruments Div. of Stryker Corporation is recalling T4 Zipper Toga sterile personal protection garments (S/M size, Catalog Number 0400-810-000). The recall involves 34,570 units from Lot number 17061794. These products were distributed in the United States, Ireland, Japan, South Korea, and the UK.
The recall is being issued because separation of material layers may occur. This defect creates a potential risk of exposure to contaminants, which could compromise the sterile integrity of the garment.
Healthcare facilities and users should stop using the affected products and contact Stryker for instructions on return or replacement. The agency has classified this as a Class II recall.
The recalled product
- Product
- T4 Zipper Toga (S/M); Catalog Number: 0400-810-000 Sterile personal protection garment
- Manufacturer
- Stryker Instruments Div. of Stryker Corporation
- Category
- Medical Device — Surgical Gowns
- Affected units
- 34,570
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 (1)
- Lot number: 17061794
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 11 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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