Stryker T5 Zipper Toga Sterile Garment Recall for Layer Separation
Stryker is recalling T5 Zipper Toga sterile garments because material layers may separate, posing 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 is classified as FDA Class II. The hazard involves a risk of harm (exposure to contaminants) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Stryker Instruments Div. of Stryker Corporation is recalling 34,570 units of T5 Zipper Toga with Peel-Away Face Shield sterile personal protection garments. The affected products are size XL/T with catalog number 0400-850-100. The recall involves specific lot numbers: 17061837, 17061859, and 17113164.
The recall was initiated because separation of material layers may occur, which creates a potential risk of exposure to contaminants. This defect compromises the sterile integrity of the garment.
The products were distributed in the United States, Ireland, Japan, South Korea, and the United Kingdom. Users of these sterile garments should stop using the affected lots and contact Stryker for further instructions.
The recalled product
- Product
- T5 Zipper Toga with Peel-Away Face Shield, (XL/T); Catalog number: 0400-850-100 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 (3)
- Lot numbers: 17061837
- 17061859
- 17113164
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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