Stryker T4 Pullover Toga Recall Due to Layer Separation Risk
Stryker is recalling T4 Pullover 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 is classified as FDA Class II and involves a risk-of-harm product (sterile garment) 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 the T4 Pullover Toga, Regular (Catalog Number: 0400-750-000). This sterile personal protection garment is subject to a Class II recall by the U.S. Food and Drug Administration.
The recall is issued because separation of material layers may occur, which creates a potential risk of exposure to contaminants. The affected lot number is 17061792.
The products were distributed nationwide in the United States, as well as in Ireland, Japan, South Korea, and the UK. Users should stop using the affected garments and contact the manufacturer for further instructions.
The recalled product
- Product
- T4 Pullover Toga, Regular ; Catalog Number: 0400-750-000 Sterile personal protection garment
- Manufacturer
- Stryker Instruments Div. of Stryker Corporation
- 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 numbers: 17061792
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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