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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 failure) where injury has not yet been reported, fitting the High severity criteria.
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 recall involves specific lot numbers and affects products distributed in the US, Ireland, Japan, South Korea, and the UK.
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.
Healthcare facilities and users should stop using the affected products and contact Stryker for instructions on return or replacement.
The recalled product
- Product
- T5 Zipper Toga with Peel-Away Face Shield, (L/XL); Catalog number: 0400-820-100 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 (11)
- Lot numbers: 17061816
- 17061836
- 17061839
- 17061853
- 17071921
- 17072017
- 17102944
- 17102948
- 17113081
- 17113141
- 17113194
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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